Heart and Vascular Clinical Trials

COMMENCE: Comparing Hypothermic Temperature During Hemiarch Surgery

• Principal Investigator:
  John Bozinovski, MD
  Email: Jovan.Bozinovski@osumc.edu
• Summary:
  A randomized study investigating if mild hypothermia (around 32°C) is better or worse than moderate hypothermia (around 26°C) for patients undergoing aortic hemiarch surgery with anterograde cerebral perfusion (ACP), aiming to reduce complications like neurological injury, kidney damage, bleeding and length of hospital stay.
• Study Details

CTSN PaCES: Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG (PACeS)

• Principal Investigator:
  Bryan Whitson, MD, PhD
  Email: Bryan.Whitson@osumc.edu
• Summary:
  This study aims to assess the effectiveness and safety of adding oral anticoagulation to antiplatelet therapy in patients with new-onset post-operative atrial fibrillation after CABG surgery. 
• Study Details

EXACT-CABG: Epicardial Delivery of XC001 Gene Therapy to Promote Angiogenesis in CAD Patients Undergoing Treatment With CABG

• Principal Investigator:
  Kukbin Choi, MD
  Email: Kukbin.Choi@osumc.edu
• Summary:
  A 26-week, multicenter, randomized, double-blind phase 2 study evaluating the safety and effectiveness of XC001 gene therapy as an additional treatment to coronary artery bypass graft (CABG) surgery for patients with symptomatic coronary artery disease and left ventricular dysfunction who may not achieve complete revascularization.
• Study Details

LeAAPS: Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

• Principal Investigator:
  Matthew Henn, MD
  Email: Matthew.Henn@osumc.edu
• Summary:
  International prospective, randomized, blinded trial assesses whether left atrial appendage exclusion during cardiac surgery reduces ischemic stroke or arterial embolism risk in patients with atrial fibrillation risk factors.
• Study Details

ROMA: Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: the ROMA trial

• Principal Investigator:
  John Bozinovski, MD
  Email: Jovan.Bozinovski@osumc.edu
• Summary
  International clinical trial investigating whether using two or more arterial grafts (MAG) is better than a single arterial graft (SAG) for coronary artery bypass grafting (CABG), aiming to reduce major events like death, stroke, and myocardial infarction (heart attack).

TITAN: Treatment In Thoracic Aortic Aneurysm: Surgery versus Surveillance (TITAN: SvS)

• Principal Investigator:
  John Bozinovski, MD
  Email: Jovan.Bozinovski@osumc.edu
• Summary:
  Multi-center randomized controlled trial comparing early surgery to watchful waiting (surveillance) for patients with asymptomatic ascending aortic aneurysms (ATAA) measuring 5.0 to 5.4 cm, aiming to provide evidence for better management guidelines.
• Study Details

VIP BOLT: Veno-Arterial ECMO Versus Off-Pump Bilateral Orthotopic Lung Transplantation

• Principal Investigator:
  Bryan Whitson, MD, PhD
  Email: Bryan.Whitson@osumc.edu
• Summary:
  The VIP BOLT trial is a multicenter prospective randomized trial that aims to compare the effectiveness of veno-arterial ECMO (VA ECMO) and off pump bilateral orthotopic lung transplantation (BOLT) in terms of primary graft dysfunction (PGD) and other outcomes. The trial is designed to provide insights into which method may lead to better outcomes for patients undergoing bilateral lung transplantation.

AAA-SHAPE: AAA-SHAPE Pivotal Randomized Controlled Trial

• Principal Investigator:
  Kristine Orion, MD
  Email: Kristine.Orion@osumc.edu
• Summary:
  Evaluation of whether IMPEDE-FX RapidFill improves abdominal aortic aneurysm sac shrinkage rates when used alongside standard EVAR stent grafts in patients eligible for elective EVAR.
• Study Details

IMPROVE-AD: IMPRoving Outcomes in Vascular DisEase - Aortic Dissection

• Principal Investigator:
  Xiaoyi Teng, MD
  Email: Xiaoyi.Teng@osumc.edu
• Summary:
  To assess if starting treatment with TEVAR (Thoracic Endovascular Aortic Repair) and medication lowers the chances of death or serious aortic problems, compared to beginning with just medication plus monitoring for any worsening, in patients who have uncomplicated type B aortic dissection.
• Study Details

LEADER-PAD: Low dose ColchicinE in pAtients with peripheral artery DiseasE to address residual vascular Risk: A randomized trial

• Principal Investigator:
  Xiaoyi Teng, MD
  Email: Xiaoyi.Teng@osumc.edu
• Summary:
  To determine whether using low-dose colchicine as anti-inflammatory therapy can decrease vascular events in people who have symptomatic peripheral artery disease.
• Study Details

sTAAABLE: Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy

• Principal Investigator:
  Kristine Orion, MD
  Email: Kristine.Orion@osumc.edu
• Summary: This randomized clinical trial will assess the efficacy of a single-dose, locally delivered endovascular treatment for patients with abdominal aortic aneurysms (AAA) measuring 3.5–5.0 cm. The study compares this intervention to standard surveillance, with follow-ups at 30/60 days, 6, 12, 18, and 24 months, and annual monitoring for up to 5 years.
• Study Details

TAMBE: Evaluation of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

• Principal Investigator:
  Kristine Orion, MD
  Email: Kristine.Orion@osumc.edu
• Summary: This is a prospective, non-randomized, multicenter study with two independent arms. The Primary Study Arm includes TAAA and pararenal aneurysms that only require the TAMBE System, featuring hypothesis-driven analysis. The Secondary Study Arm focuses on TAAA cases requiring both the TAMBE System and CTAG devices, with non-hypothesis-driven analysis.
• Study Details

TAMBE Post-Approval: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study

• Principal Investigator:
  Kristine Orion, MD
  Email: Kristine.Orion@osumc.edu
• Summary:
  This study is to validate the continued positive benefit-risk profile of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in real-world clinical practice and to assess the effectiveness of the TAMBE Device training program.
• Study Details

The PROVE Trial: PROmote weight loss in obese PAD patients to preVEnt mobility Loss

• Principal Investigator:
  Matthew Corriere, MD
  Email: matthew.corriere@osumc.edu
• Summary:
  Randomized clinical study designed to evaluate if combining a weight loss program with walking exercise leads to greater improvement, or less decline, in six-minute walk distance after 12 months compared to walking exercise alone for people who have PAD and a BMI over 25 kg/m2.
• Study Details

VBX 24-03 GORE®: VIABAHN® VBX Balloon Expandable Endoprosthesis used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to treat Aortoiliac Occlusive Disease

• Principal Investigator:
  K. Benjamin Lee, MD
  Email: benjamin.lee@osumc.edu
• Summary:
  Examine the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (referred to as the "VBX Device" or "VBX Stent Graft") after its approval. It will also evaluate how well it works during covered endovascular reconstruction of the aortic bifurcation (CERAB) for treating aortoiliac occlusive disease (AIOD).
• Study Details

COMPANION AI

• Principal Investigator: 
  John Hummel, MD 
  Email: John.Hummel@osumc.edu
• Summary:
  Registry for patients treated with VX1 VOLTA technology to observe medium-to-long-term safety and performance outcomes.
• Patient Criteria:
  An indication for afib ablation or received an afib ablation in the last 24 months using VX1
• Study Details

ERADICATE AF II

• Principal Investigator:
  Ralph Augostini, MD
  Email: Ralph.Augostini@osumc.edu
• Summary:
  Randomized trial to determine if patients with persistent AF with controlled hypertension or without hypertension who are randomized to catheter ablation (PVI) or PVI + adjunctive RDN have reduced AF burden over time in comparison to patients who undergo only PVI.
• Patient Criteria:
  - Persistent afib referred for PVI based on current guidelines
  - No prior hypertension or hypertension controlled on medical therapy
• Study Details

REACT AF

• Principal Investigator:
  Salvatore Savona, MD
  Email: Salvatore.Savona@osumc.edu
• Summary:
  Randomized trial comparing the current SOC of continuous DOAC use versus time delimited DOAC guided by an AF sensing Smart Watch (Apple Watch) in patients with a history of paroxysmal or persistent AF and low-to-moderate stroke risk.
• Patient Criteria:
  - History of non-permanent afib on DOAC
  - CHA2DS2-VASc 1-4 for men; 2-4 for women
  - No prior TIA or stroke
• Study Details

PULSED AF PAS

• Principal Investigator: 
  John Hummel, MD 
  Email: John.Hummel@osumc.edu
• Summary:
  Post approval study to provide continuing evaluation and periodic reporting of safety and effectiveness of market released products as a part of the Medtronic cardiac ablation post-market study platform.
• Patient Criteria:
  Planned PVI using the PulseSelect PFA System
• Study Details

REMATCH

• Principal Investigator:
  Salvatore Savona, MD
  Email: Salvatore.Savona@osumc.edu
• Summary:
  Evaluating the safety and effectiveness of the FARAWAVE and FARAPOINT pulsed field ablation catheters for re-treatment of persistent atrial fibrillation after an initial failed procedure.
• Patient Criteria:
  - A single prior afib ablation within the last 5 years
  - Documentation of persistent afib either before the prior ablation/development after the prior ablation
  - Recurrence of afib at least 60 days after the prior ablation
• Study Details

SMART Ablation

• Principal Investigator: 
  John Hummel, MD 
  Email: John.Hummel@osumc.edu
• Summary:
  Assessment of the correlation of high resolution contrast enhanced MRI sites of arrhythmogenic fibrotic substrate, with sites of extra-pulmonary vein localized drivers in atrial fibrillation.
• Patient Criteria:
  Paroxysmal or persistent afib undergoing or having undergone clinically-indicated ablation procedures employing multi-electrode extra-pulmonary vein mapping with pre-operative MRI or CT
• Study Details

ALT FLOW II

• Principal Investigators:
  Rami Kahwash, MD (Email: Rami.Kahwash@osumc.edu)
  Scott Lilly, MD, PhD (Email: Scott.Lilly@osumc.edu)
• Summary:
  Randomized, blinded, sham-controlled trial evaluating LA-CS shunt in patients with HFpEF.
• Patient Criteria:
  - LVEF greater than or equal to 40%
  - NYHA II or greater
  - Heart failure hospitalization within 12 months, elevated NTproBNP, or intensification of oral diuretics
• Study Details

EASE-HF

• Principal Investigators:
  Rami Kahwash, MD (Email: Rami.Kahwash@osumc.edu)
  Scott Lilly, MD, PhD (Email: Scott.Lilly@osumc.edu)
• Summary:
  Single arm trial evaluating the InterShunt PAS-C System in subjects with heart failure. The PAS-C System creates a shunt but does not leave behind a permanent implant.
• Patient Criteria:
  - LVEF less than or equal to 40%
  - NYHA II or greater
  - Heart failure hospitalization within 12 months or elevated NTproBNP
• Study Details

RESPONDER-HF

• Principal Investigators:
  Rami Kahwash, MD (Email: Rami.Kahwash@osumc.edu)
  Scott Lilly, MD, PhD (Email: Scott.Lilly@osumc.edu)
• Summary:
  Randomized, blinded, sham-controlled trial evaluating interatrial shunt in patients with HFpEF.
• Patient Criteria:
  - LVEF greater than or equal to 40%
  - NYHA II or greater
  - Heart failure hospitalization within 12 months or elevated NTproBNP
• Study Details

ATRIUM

• Principal Investigator:
  Adam Potter, MD, PhD
  Email: Adam.Potter@osumc.edu
• Summary:
  Randomized, blinded trial evaluating Abatacept for immune checkpoint inhibitor associated myocarditis.
• Patient Criteria:
  - Hospitalized and evidence of myocarditis
  - Recent use of FDA approved immune checkpoint inhibitor
   Serum evidence of myocardial injury
• Study Details

Developing a Single-Session Cardiopulmonary CPET-CMR Exam at Low Field MRI

• Principal Investigator:
  Juliet Varghese, PhD
  Email: Juliet.Varghese@osumc.edu
• Summary:
  Development and validation of a single-session comprehensive cardiopulmonary exercise magnetic resonance (CPET-CMR) exam on a wide-bore 0.55T MR system for assessment of symptomatic post pulmonary embolism (PE) patients, and for initial evaluation of suspected Pulmonary hypertension (PHTN).
• Patient Criteria:
  - Diagnostic work up of pulmonary disease
  - No contraindication for MRI or exercise 

Exercise CMR

• Principal Investigator:
  Yuchi Han, MD
  Email: Yuchi.Han@osumc.edu
• Summary:
  Comparison of imaging parameters on exercise stress CMR vs. resting CMR to identify left or right ventricular dysfunction that is only elicited with exercise.
• Patient Criteria:
  - Ability to participate in exercise testing
  - Either symptomatic with SOB at rest or with exertion but with normal resting cardiac function, OR cardiac dysfunction identified on imaging studies but are asymptomatic
  - No contraindication for MRI

Ferumoxytol-enhanced MRI with Exercise-Stress to Evaluate Patients with MVR

• Principal Investigator:
  Rizwan Ahmad, PhD
  Email: Rizwan.Ahmad@osumc.edu
• Summary:
  Development of an exercise stress cardiovascular magnetic resonance imaging (MRI) protocol that can lead to a better treatment plan for mitral valve regurgitation patients.
• Patient Criteria:
  - Moderate to severe mitral valve regurgitation
  - No contraindication for MRI, exercise or ferumoxytol 

Healthy Diet Study

• Principal Investigators:
  Yuchi Han, MD (Email: Yuchi.Han@osumc.edu)
  Orlando Simonetti, PhD (Email: Orlando.Simonetti@osumc.edu)
• Summary:
  Randomized unblinded CMR trial to evaluate the effects of a ketogenic diet (KD) compared to mixed diet (MD) on exercise tolerance in subjects with metabolic phenotype of HFpEF.
• Patient Criteria:
  - LVEF 40% or greater
  - NYHA Class I-III heart failure
  - BMI 25 or greater or Type 2 Diabetes Mellitus or prediabetes (fasting glucose of 100 - 125 mg/dL or hemoglobin A1C 5.7-6.4%) or metabolic syndrome
  - Ability to participate in exercise treadmill testing
  - No contraindication for MRI 
• Study Details

Ketone Ester Study

• Principal Investigators:
  Yuchi Han, MD (Email: Yuchi.Han@osumc.edu)
  Orlando Simonetti, PhD (Email: Orlando.Simonetti@osumc.edu)
• Summary:
  Randomized, blinded CMR trial to evaluate how a ketone ester beverage affects heart function and health in people with type II diabetes.
• Patient Criteria:
  - Type II diabetes mellitus
  - BMI 25 or greater
  - Stable medical therapy for at least 1 months as determined by the treating physician (no plan to change between the two testing sessions)
  - No contraindication for MRI 
• Study Details

Impact of Bariatric Surgery on Cardiac Structure and Function

• Principal Investigator:
  Orlando Simonetti, PhD
  Email: Orlando.Simonetti@osumc.edu
• Summary:
  Development and Validation of Cardiovascular MRI Techniques on a Low-Field, Ultra-Wide Bore System to Assess Patients with Severe Obesity.
• Patient Criteria:
  - An existing diagnosis of severe obesity (BMI ≥ 40 kg/m2) and are scheduled for Roux-en-Y or sleeve gastrectomy bariatric surgery
  - Cardiac exam before surgery
  - No contraindication for MRI

PVC Imaging

• Principal Investigator:
  Yuchi Han, MD
  Email: Yuchi.Han@osumc.edu
• Summary:
  Observational study in patients who are potentially undergoing PVC suppression (ablation or medications) to perform CMR pre-PVC suppression and 6-24 months post-PVC suppression.
• Patient Criteria:
  - PVC burden 9.5% or greater as determined by 12-lead ECG or Holter
  - No persistent a-fib, HF diagnosis within last 6 months, secondary causes of cardiomyopathies (i.e. sarcoidosis, amyloid, ARVC, etc.), or severe claustrophobia
  - No contraindication for MRI 

RECHARGE

• Principal Investigator:
  Ernest Mazzaferri, MD
  Email: Ernest.Mazzaferri@osumc.edu
• Summary:
  Randomized trial comparing PCI versus CABG exclusively in women and minorities: Revascularization Choices Among under-Represented Groups Evaluation.
• Patient Criteria:
  - Female sex and/or Black race or Hispanic Ethnicity- Multivessel or left main coronary artery disease intended for revasc
  - Equipoise between CABG and PCI per local heart team
• Study Details–Women
• Study Details–Minorities

The Ohio State University Cardiovascular Disease Biorepository

• Principal Investigator:
  Richard Gumina, MD, PhD
  Email: Richard.Gumina@osumc.edu
• Summary:
  Observational study to collect biologoical specimens and associated clinical data from patients with cardiovascular disorders, which will serve as a source of clinical specimens for the future study of these disorders.
• Patient Criteria:
  - Adults affected by heritable disorders, unaffected adults, affected and unaffected children
  - Adults with known or suspected cardiovascular disease or associated clinical diagnoses
  - Individuals who are at high risk of SARS-Cov-2 infection or patients suspected of or with confirmed SARS-Cov-2 infection
  - Deceased individuals and tissue
  - Adult healthy volunteers

Inflammatory and Genetic Biomarkers in Atherosclerotic Cardiovascular Disease

• Principal Investigator:
  Richard Gumina, MD, PhD
  Email: Richard.Gumina@osumc.edu
• Summary:
  Observational study investigating the impact of CD39 and CD73 gene-associated single nucleotide polymorphisms on the inflammatory cell phenotype and function in the absence (healthy volunteers) and presence (patients) of atherosclerotic cardiovascular disease.
• Patient Criteria:
  - Adult patients weighing greater than 80 pounds with Hemoglobin >6 gm/L
  - Referred for CABG surgery
  - Referred for CT angiography for evaluation of suspected coronary artery disease
  - Referred to cardiac catheterization laboratory for evaluation of: Suspected coronary artery disease; ST-elevation myocardial infarction; Non-ST elevation myocardial infarction; Out of hospital cardiac arrest; Acute cardiogenic shock; Adult healthy volunteers weighing greater than 80 pounds with no known coronary artery disease

Protocol for Genetic Analysis of Patients with Spontaneous Coronary Artery Dissection

• Principal Investigator:
  Richard Gumina, MD, PhD
  Email: Richard.Gumina@osumc.edu
• Summary:
  Observational study to identify patients with spontaneous coronary artery dissection (SCAD) for genetic analysis with whole exome sequencing. This will allow for gene identification as potential diagnostic markers of individuals at risk, as targets for therapeutic intervention and for further understanding of the pathophysiology of the disease.
• Patient Criteria:
  Adult patients with a diagnosis of spontaneous coronary artery dissection

CRAFT-HF

• Principal Investigator:
  Vaiibhav Patel, MD
  Email: Vaiibhav.Patel@osumc.edu
• Summary:
  Randomized, blinded trial assessing the effects of the investigational drug COR-1167 in subjects hospitalized due to worsening of heart failure. COR-1167 is the corticotropin-releasing factor type 2 (CRF2) peptide agonist.
• Patient Criteria:
  - Hospitalized with ADHF and has a prior HF hospitalization within the last 12 months
  - Requiring treatment with IV diuretics for volume overload
  - At risk for diuretic resistance
  - NTproBNP of 1000 pg/mL or greater
• Study Details

DORAYA-HF

• Principal Investigators:
  Rami Kahwash, MD (Email: Rami.Kahwash@osumc.edu)
  Scott Lilly, MD, PhD (Email: Scott.Lilly@osumc.edu)
• Summary:
  Randomized trial assessing the Doraya Catheter (a temporary intravenous flow regulator that is percutaneously positioned in the inferior vena cava below the level of the renal veins) for the treatment of volume overload in Acute Heart Failure Patients with Insufficient Response to Diuretics.
• Patient Criteria:
  - Admitted with ADHF (LOA less than 10 days)
  - Insufficiently responding to diuretics as specified by protocol
  - Evidence of continued volume overload
• Study Details

DRAIN-HF

• Principal Investigator:
  Indra Bole, MD
  Email: Indra.Bole@osumc.edu
• Summary:
  Randomized trial evaluating DiuRetics Alone vs. AortIx ENdovascular Device for Acute Heart Failure. The arotix is a circulatory support device placed in the aorta and is designed to pump blood from the aortic arch to the lower aorta.
• Patient Criteria:
  - Admitted with ADHF (LOA less than 21 days)
  - Insufficiently responding to maximum tolerated diuretics
  - Evidence of continued volume overload
• Study Details

FASTR

• Principal Investigators:
  Jason Bischof, MD (Email: Jason.Bischof@osumc.edu)
  Vaiibhav Patel, MD (Email: Vaiibhav.Patel@osumc.edu)
• Summary:
  Randomized trial evaluating the Reprieve Decongestion Management System (DMS) for fluid management in acute decompensated heart failure subjects.
• Patient Criteria:
  - Hospitalized with ADHF
  - At least 10lbs over dry weight
  - At risk for diuretic resistance
• Study Details

AIM HIGHer

• Principal Investigator:
  Ayesha Hasan, MD
  Email: Ayesha.Hasan@osumc.edu
• Summary:
  Randomized, blinded trial assessing the implantable CCM in the heart failure group with higher ejection fraction (40–60%).
• Patient Criteria:
  - LVEF 40 – 60%
  - Heart failure hospitalization within 12 months or elevated NTproBNP
  - Scheduled, oral loop diuretic treatment (not PRN)
• Study Details

ELEVATE-HFpEF

• Principal Investigator:
  Mahmoud Houmsse, MD
  Email: Mahmoud.Houmsse@osumc.edu
• Summary:
  Randomized, blinded trial evaluating the safety and efficacy of dual chamber personalized pacing for the treatment of patients with heart failure with preserved ejection fraction.
• Patient Criteria:
  - Age 40 or over
  - LVEF 50% or greater
  - Heart failure hospitalization within 12 months OR NYHA II with protocol defined risk criteria
• Study Details

REBALANCE HF

• Principal Investigator:
  Alexandria Miller, MD
  Email: Alexandria.Miller@osumc.edu
• Summary:
  Randomized, blinded, sham-controlled trial evaluating splanchnic nerve ablation in patients with HFpEF.
• Patient Criteria:
  - EF 50% or greater
  - Age 40 or greater
  - Heart failure hospitalization in the last 12 months, or elevated NTproBNP, or elevated PCWP at either rest or exercise
• Study Details

RESPONDER-HF

• Principal Investigators:
  Rami Kahwash, MD (Email: Rami.Kahwash@osumc.edu)
  Scott Lilly, MD, PhD (Email: Scott.Lilly@osumc.edu)
• Summary:
  Randomized, blinded, sham-controlled trial evaluating interatrial shunt in patients with HFpEF.
• Patient Criteria:
  - LVEF greater than or equal to 40%
  - NYHA II or greater
  - Heart failure hospitalization within 12 months or elevated NTproBNP
• Study Details

EASE-HF

• Principal Investigators:
  Rami Kahwash, MD (Email: Rami.Kahwash@osumc.edu)
  Scott Lilly, MD, PhD (Email: Scott.Lilly@osumc.edu)
• Summary:
  Single arm trial evaluating the InterShunt PAS-C System in subjects with heart failure. The PAS-C System creates a shunt but does not leave behind a permanent implant.
• Patient Criteria:
  - LVEF less than or equal to 40%
  - NYHA II or greater
  - Heart failure hospitalization within 12 months or elevated NTproBNP
• Study Details

EMPOWER

• Principal Investigator:
  Vaiibhav Patel, MD
  Email: Vaiibhav.Patel@osumc.edu
• Summary:
  Randomized, blinded, sham-controlled trial assessing the effectiveness of transcatheter annular reduction in heart failure patients with any degree of mitral regurgitation and left ventricular dilation.
• Patient Criteria:
  - At least mild functional MR
  - LVEDD greater than or equal to 57mm
  - LVEF less than or equal to 50% 
• Study Details

FUTURE-HFII (aka FIRE1)

• Principal Investigator:
  Rami Kahwash, MD
  Email: Rami.Kahwash@osumc.edu
• Summary:
  Single arm trial evaluating the NORM system for physician directed, patient self-management of diuretics based on daily measurements of IVC diameter and collapsibility.
• Patient Criteria:
  - Daily loop diuretic dose of 40mg Lasix or equivalent
  - Heart failure hospitalization in the last 12 months and/or elevated NTproBNP
• Study Details

Sensydia

• Principal Investigator:
  Scott Lilly, MD, PhD
  Email: Scott.Lilly@osumc.edu
• Summary:
  Single arm trial evaluating the accuracy of the Cardiac Performance System (CPS), a non-invasive device, for measuring hemodynamic parameters in adult patients undergoing clinically indicated right heart catheterization.
• Patient Criteria:
  Undergoing a clinically indicated RHC
• Study Details

Amyloidosis

TRITON

• Principal Investigator:
  Ajay Vallakati, MBBS
  Email: Ajay.Vallakati@osumc.edu
• Summary:
  Randomized, blinded trial evaluating the Efficacy and Safety of Nucresiran in Patients WithTransthyretin-Mediated Amyloidosis With Cardiomyopathy (ATTRAmyloidosis With Cardiomyopathy.
• Patient Criteria:
  - ATTR Amyloidosis
  - Current treatment with a diuretic or heart failure hospitalization within the last 12 months
• Study Details

Sarcoidosis

CHASM

• Principal Investigator:
  Steven Kalbfleisch, MD
  Email: Steven.Kalbfleisch@osumc.edu
• Summary:
  Randomized trial to evaluate the efficacy of prednisone verses prednisone + methotrexate in the treatment of cardiac sarcoidosis.
• Patient Criteria:
  - Cardiac sarcoidosis presenting with protocol defined findings
  - No current or recent (within 2 months) non-topical treatment for sarcoidosis
• Study Details

CT vs TEE Post-LAAC

• Principal Investigator:
  Mahmoud Houmsse, MD
  Email: Mahmoud.Houmsse@osumc.edu
• Summary:
  Non-randomized trial to compare Cardiac CT with TEE to evaluate Watchman FLX LAA Occluder Device Characteristics.
• Patient Criteria:
  - Planned LAAC procedure using the Watchman FLX Pro device
  - eGFR of 30 or above
• Study Details

SIMPLAAFY

• Principal Investigator:
  Mahmoud Houmsse, MD
  Email: Mahmoud.Houmsse@osumc.edu
• Summary:
  Randomized trial evaluating the safety and effectiveness of two monotherapy regimens (aspirin only or reduced dose of non-vitamin K antagonist oral anticoagulant) versus dual antiplatelet therapy following implant of the Watchman FLX Pro device
• Patient Criteria:
  - Planned LAAC procedure using the Watchman FLX Pro device
  - Suitable for all protocol defined drug regimens
  - LVEF 30% or above
• Study Details

CORCINCH

• Principal Investigators:
  Konstantinos Boudoulas, MD (Email: Konstantinos.Boudoulas@osumc.edu)
  Vaiibhav Patel, MD (Email: Vaiibhav.Patel@osumc.edu)
• Summary:
  Randomized trial to assess the safety and effectiveness of the AccuCinch Ventricular Restoration System in HFrEF patients with symptomatic heart failure.
• Patient Criteria:
  - LVEDD greater than or equal to 55mm
  - LVEF 20% - 40%
• Study Details

EMPOWER

• Principal Investigator:
  Vaiibhav Patel, MD
  Email: Vaiibhav.Patel@osumc.edu
• Summary:
  Randomized, blinded, sham-controlled trial assessing the effectiveness of transcatheter annular reduction in heart failure patients with any degree of mitral regurgitation and left ventricular dilation.
• Patient Criteria:
  - At least mild functional MR
  - LVEDD greater than or equal to 57mm
  - LVEF less than or equal to 50%
• Study Details

APOLLO

• Principal Investigators:
  Konstantinos Boudoulas, MD (Email: Konstantinos.Boudoulas@osumc.edu)
  Bryan Whitson, MD, PhD (Email: Bryan.Whitson@osumc.edu)
• Summary:
  Single arm trial assessing Medtronic’s Intrepid transcatheter mitral valve in patients with symptomatic moderate-severe mitral regurgitation OR moderate mitral regurgitation in the presence of MAC.
• Patient Criteria:
  - Moderate-severe or greater MR OR moderate MR with MAC/MS
  - Unsuitable for mitral valve surgery or commercial mitraclip
  - LVEF greater than or equal to 25%
• Study Details

EMPOWER

• Principal Investigator:
  Vaiibhav Patel, MD
  Email: Vaiibhav.Patel@osumc.edu
• Summary:
  Randomized, blinded, sham-controlled trial assessing the effectiveness of transcatheter annular reduction in heart failure patients with any degree of mitral regurgitation and left ventricular dilation.
• Recruiting patients with:
  - At least mild functional MR
  - LVEDD greater than or equal to 57mm
  - LVEF less than or equal to 50%
• Study Details

ACCLAIM-Lp(a)

• Principal Investigator:
  Wesley Milks, MD
  Email: Wesley.Milks@osumc.edu
• Summary:
  Randomized, double blind, placebo-controlled trial investigating the effect of Lepodisiran on the reduction of MACE in adults with elevated Lp(a) who have established atherosclerotic cardiovascular disease or are at risk for a first cardiovascular event.
• Patient Criteria:
  - Lp(a) > 175 nmol/L (screening lab)
  - Established ASCVD with event/revasc OR at risk for first CV event
• Study Details

CASCADE FH Registry

• Principal Investigator:
  Wesley Milks, MD
  Email: Wesley.Milks@osumc.edu
• Summary:
  National registry for patients with familial hypercholesterolemia.
• Patient Criteria:
  Familial hypercholesterolemia

PEERLESS II

• Principal Investigator:
  Richard Gumina, MD, PhD
  Email: Richard.Gumina@osumc.edu
• Summary:
  Randomized trial comparing FlowTriever System plus anticoagulation versus anticoagulation alone in patients with intermediate-risk acute PE.
• Patient Criteria:
  - Intermediate risk PE with symptom onset in the last 14 days
  - RV dysfunction
  - Appropriate for catheter-based intervention
• Study Details

COSIRA

• Principal Investigator:
  Scott Lilly, MD, PhD
  Email: Scott.Lilly@osumc.edu
• Summary:
  Randomized, blinded, sham-controlled trial evaluating the Reducer system for treatment of patients with refractory angina treated with maximally tolerated guideline directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization.
• Patient Criteria:
  - Refractory angina (CCS class II – IV) and no therapeutic options
  - LVEF greater than or equal to 30%
• Study Details

EXACT II

• Principal Investigator:
  Konstantinos Boudoulas, MD
  Email: Konstantinos.Boudoulas@osumc.edu
• Summary:
  Randomized, blinded trial assessing safety, feasibility, and efficacy of percutaneous endovascular catheter-facilitated intramyocardial delivery of XC001 in patients with refractory angina due to obstructive coronary artery disease.
• Patient Criteria:
  - Refractory angina (CCS class II – IV) and no therapeutic options
  - LVEF greater than or equal to 25%
• Study Details

CLASP TR CAS

• Principal Investigators:
  Konstantinos Boudoulas, MD (Email: Konstantinos.Boudoulas@osumc.edu)
  Scott Lilly, MD, PhD (Email: Scott.Lilly@osumc.edu)
• Summary:
  Continued access, single arm trial evaluating the safety and effectiveness of the PASCAL Transcatheter Valve Repair System for the treatment of severe tricuspid regurgitation.
• Patient Criteria:
  - Symptomatic, severe TR
  - Intermediate or greater risk for tricuspid valve surgery
  - LVEF greater than or equal to 25%
• Study Details

RADIATE VT

• Principal Investigator:
  Jeremy Brownstein
  Email: Jeremy.Brownstein@osumc.edu
• Summary:
  Randomized trial evaluating cardiac radioablation versus repeat catheter ablation for patients with high-risk refractory Ventricular Tachycardia.
• Patient Criteria:
  - High risk refractory VT
  - Clinical indication for a repeat CA procedure for scar-mediated VT
  - Failed amiodarone therapy or intolerant to amiodarone
• Study Details