Looking to participate in a clinical trial?
The Ohio State University Heart and Vascular Center is dedicated to advancing cardiovascular care through innovative research and clinical discovery. Our multidisciplinary team engages in clinical trials that assess novel device-based and pharmaceutical therapies designed to enhance outcomes for individuals with heart and vascular diseases.
The Heart and Vascular Research Organization (HVRO) serves as our dedicated clinical trials research unit, conducting comprehensive studies across a broad range of cardiovascular conditions. These include heart failure, cardiac arrhythmias, coronary artery disease and angina, aortic aneurysms, peripheral artery disease, valvular heart disease, lipid disorders, and sleep-related cardiovascular disorders. Currently, HVRO manages over 150 ongoing research projects, encompassing investigator-initiated studies, NIH-funded clinical trials, as well as large-scale national and international industry-sponsored research.
Our mission is to translate scientific discovery into meaningful, real-world therapies that improve the lives of patients while advancing the future of cardiovascular medicine.
For more information about participating in a heart and vascular clinical trial at The Ohio State University Heart and Vascular Center, please speak to your physician or contact the HVRO at 614-685-4619 or email cardiovascular.research@osumc.edu.
Active clinical trials
Cardiac Surgery
CTSN PaCES: Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG (PACeS)
Dr. Bryan Whitson (Bryan.Whitson@osumc.edu)
LeAAPS: Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Dr. Matthew Henn (Matthew.Henn@osumc.edu)
ROMA: Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: the ROMA trial
Dr. Jovan Bozinovski (Jovan.Bozinovski@osumc.edu)
TITAN: Treatment In Thoracic Aortic Aneurysm: Surgery versus Surveillance (TITAN: SvS)
Dr. Jovan Bozinovski (Jovan.Bozinovski@osumc.edu)
COMMENCE: Comparing Hypothermic Temperature During Hemiarch Surgery
Dr. Jovan Bozinovski (Jovan.Bozinovski@osumc.edu)
A Randomized Controlled Trial of Mild vs Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery with Anterograde Cerebral Perfusion.
VIP BOLT: Veno-Arterial ECMO Versus Off-Pump Bilateral Orthotopic Lung Transplantation
Dr. Bryan Whitson (Bryan.Whitson@osumc.edu)
VIP BOLT Trial A Multicenter Prospective Randomized Trial.
EXACT-CABG
Dr. Kukbin Choi (Kukbin.Choi@osumc.edu)
A 26-Week (with 26 Week Extension) Randomized, Multi-Center, Double-Blind Phase 2 Study to Evaluate the Efficacy and Safety of XC001 Gene Therapy as an Adjunct to Coronary Artery Bypass Graft Surgery for Patients with Symptomatic Coronary Artery Disease with Left Ventricular Dysfunction at Risk for Incomplete Revascularization
Vascular Surgery
AAA-SHAPE: AAA-SHAPE Pivotal Randomized Controlled Trial
Dr. Kristine Orion (Kristine.Orion@osumc.edu)
sTAAABLE: Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy
Dr. Kristine Orion (Kristine.Orion@osumc.edu)
TAMBE: Evaluation of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
Dr. Kristine Orion (Kristine.Orion@osumc.edu)
TAMBE Post-Approval: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
Dr. Kristine Orion (Kristine.Orion@osumc.edu)
IMPROVE-AD: IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
Dr. Xiaoyi Teng (Xiaoyi.Teng@osumc.edu)
LEADER-PAD: Low dose ColchicinE in pAtients with peripheral artery DiseasE to address residual vascular Risk: A randomized trial
Dr. Xiaoyi Teng (Xiaoyi.Teng@osumc.edu)
VBX 24-03 GORE®: VIABAHN® VBX Balloon Expandable Endoprosthesis used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to treat Aortoiliac Occlusive Disease
Dr. K. Benjamin Lee (benjamin.lee@osumc.edu)
The PROVE Trial: PROmote weight loss in obese PAD patients to preVEnt mobility Loss
Dr. Matthew Corriere (matthew.corriere@osumc.edu)
Cardiovascular Medicine
REMATCH
Dr. Savona (Salvatore.Savona@osumc.edu)
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
Recruiting patients with:
- 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
ERADICATE AF II
Dr. Augostini (Ralph.Augostini@osumc.edu)
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
Recruiting patients with:
- Persistent afib referred for PVI based on current guidelines
- No prior hypertension or hypertension controlled on medical therapy
REACT AF
Dr. Savona (Salvatore.Savona@osumc.edu)
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
Recruiting patients with:
- History of non-permanent afib on DOAC
- CHA2DS2-VASc 1-4 for men; 2-4 for women
- No prior TIA or stroke
COMPANION AI
Dr. Hummel (John.Hummel@osumc.edu)
Registry for patients treated with VX1 VOLTA technology to observe medium-to-long-term safety and performance outcomes.
Recruiting patients with:
- An indication for afib ablation or received an afib ablation in the last 24 months using VX1
PULSED AF PAS
Dr. Hummel (John.Hummel@osumc.edu)
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
Recruiting patients with:
- Planned PVI using the PulseSelect PFA System
SMART Ablation
Dr. Hummel (John.Hummel@osumc.edu)
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
Recruiting patients with:
- 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
ALT FLOW II
Dr. Lilly/Dr. Kahwash (Scott.Lilly@osumc.edu; Rami.Kahwash@osumc.edu)
Randomized, blinded, sham-controlled trial evaluating LA-CS shunt in patients with HFpEF
Recruiting patients with:
- LVEF greater than or equal to 40%
- NYHA II or greater
- Heart failure hospitalization within 12 months, elevated NTproBNP, or intensification of oral diuretics
RESPONDER-HF
Dr. Lilly/Dr. Kahwash (Scott.Lilly@osumc.edu; Rami.Kahwash@osumc.edu)
Randomized, blinded, sham-controlled trial evaluating interatrial shunt in patients with HFpEF
Recruiting patients with:
- LVEF greater than or equal to 40%
- NYHA II or greater
- Heart failure hospitalization within 12 months or elevated NTproBNP
EASE-HF
Dr. Kahwash/Dr. Lilly (Rami.Kahwash@osumc.edu; Scott.Lilly@osumc.edu)
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
Recruiting patients with:
- LVEF less than or equal to 40%
- NYHA II or greater
- Heart failure hospitalization within 12 months or elevated NTproBNP
ATRIUM
Dr. Potter (Adam.Potter@osumc.edu)
Randomized, blinded trial evaluating Abatacept for immune checkpoint inhibitor associated myocarditis
Recruiting patients with:
- Hospitalized and evidence of myocarditis
- Recent use of FDA approved immune checkpoint inhibitor
- Serum evidence of myocardial injury
RECHARGE
Dr. Mazzaferri (Ernest.Mazzaferri@osumc.edu)
Randomized trial comparing PCI versus CABG exclusively in women and minorities: Revascularization Choices Among under-Represented Groups Evaluation
Recruiting patients with:
- 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
DORAYA-HF
Dr. Kahwash/Dr. Lilly (Rami.Kahwash@osumc.edu; Scott.Lilly@osumc.edu)
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
Recruiting patients with:
- Admitted with ADHF (LOA less than 10 days)
- Insufficiently responding to diuretics as specified by protocol
- Evidence of continued volume overload
DRAIN-HF
Dr. Bole (Indra.Bole@osumc.edu)
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.
Recruiting patients with:
- Admitted with ADHF (LOA less than 21 days)
- Insufficiently responding to maximum tolerated diuretics
- Evidence of continued volume overload
FASTR
Dr. Bischof/Dr. Patel (Jason.Bischof@osumc.edu; Vaiibhav.Patel@osumc.edu)
Randomized trial evaluating the Reprieve Decongestion Management System (DMS) for fluid management in acute decompensated heart failure subjects
Recruiting patients with:
- Hospitalized with ADHF
- At least 10lbs over dry weight
- At risk for diuretic resistance
CRAFT-HF
Dr. Patel (Vaiibhav.Patel@osumc.edu)
Randomized, blinded trial assessing the effects of the investigational drug COR-1167 in subjects hospitalised due to worsening of heart failure. COR-1167 is the corticotropin-releasing factor type 2 (CRF2) peptide agonist.
Recruiting patients with:
- 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
AIM HIGHer
Dr. Hasan (Ayesha.Hasan@osumc.edu)
Randomized, blinded trial assessing the implantable CCM in the heart failure group with higher ejection fraction (40–60%)
Recruiting patients with:
- LVEF 40 – 60%
- Heart failure hospitalization within 12 months or elevated NTproBNP
- Scheduled, oral loop diuretic treatment (not PRN)
ELEVATE-HFpEF
Dr. Houmsse (Mahmoud.Houmsse@osumc.edu)
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
Recruiting patients with:
- Age 40 or over
- LVEF 50% or greater
- Heart failure hospitalization within 12 months OR NYHA II with protocol defined risk criteria
ALT FLOW II
Dr. Lilly/Dr. Kahwash (Scott.Lilly@osumc.edu; Rami.Kahwash@osumc.edu)
Randomized, blinded, sham-controlled trial evaluating LA-CS shunt in patients with HFpEF
Recruiting patients with:
- LVEF greater than or equal to 40%
- NYHA II or greater
- Heart failure hospitalization within 12 months, elevated NTproBNP, or intensification of oral diuretics
RESPONDER-HF
Dr. Lilly/Dr. Kahwash (Scott.Lilly@osumc.edu; Rami.Kahwash@osumc.edu)
Randomized, blinded, sham-controlled trial evaluating interatrial shunt in patients with HFpEF
Recruiting patients with:
- LVEF greater than or equal to 40%
- NYHA II or greater
- Heart failure hospitalization within 12 months or elevated NTproBNP
CORCINCH
Dr. Boudoulas/Dr. Patel (Konstantinos.Boudoulas@osumc.edu; Vaiibhav.Patel@osumc.edu)
Randomized trial to assess the safety and effectiveness of the AccuCinch Ventricular Restoration System in HFrEF patients with symptomatic heart failure
Recruiting patients with:
- LVEDD greater than or equal to 55mm
- LVEF 20% - 40%
EASE-HF
Dr. Kahwash/Dr. Lilly (Rami.Kahwash@osumc.edu; Scott.Lilly@osumc.edu)
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
Recruiting patients with:
- LVEF less than or equal to 40%
- NYHA II or greater
- Heart failure hospitalization within 12 months or elevated NTproBNP
GenePhit
Dr. Boudoulas (Konstantinos.Boudoulas@osumc.edu)
Randomized, blinded trial to evaluate the efficacy, safety and tolerability of intracoronary infusion of NAN-101 in adult subjects with New York Heart Association (NYHA) Class III heart failure and non-ischemic cardiomyopathy.
Recruiting patients with:
- LVEF 15-35%
- NYHA Class III heart failure
FUTURE-HF (aka FIRE1)
Dr. Kahwash (Rami.Kahwash@osumc.edu)
Single arm trial evaluating the NORM system for physician directed, patient self-management of diuretics based on daily measurements of IVC diameter and collapsibility
Recruiting patients with:
- Daily loop diuretic dose of 40mg Lasix or equivalent
- Heart failure hospitalization in the last 12 months and/or elevated NTproBNP
Sensydia
Dr. Lilly (Scott.Lilly@osumc.edu)
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
Recruiting patients with:
- Undergoing a clinically indicated RHC
Sarcoidosis
CHASM
Dr. Kalbfleisch (Steven.Kalbfleisch@osumc.edu)
Randomized trial to evaluate the efficacy of prednisone verses prednisone + methotrexate in the treatment of cardiac sarcoidosis
Recruiting patients with:
- Cardiac sarcoidosis presenting with protocol defined findings
- No current or recent (within 2 months) non-topical treatment for sarcoidosis
Amyloidosis
TRITON
Dr. Vallakati (Ajay.Vallakati@osumc.edu)
Randomized, blinded trial evaluating the Efficacy and Safety of Nucresiran in Patients WithTransthyretin-Mediated Amyloidosis With Cardiomyopathy (ATTRAmyloidosis With Cardiomyopathy
Recruiting patients with:
- ATTR Amyloidosis
- Current treatment with a diuretic or heart failure hospitalization within the last 12 months
SIMPLAAFY
Dr. Houmsse (Mahmoud.Houmsse@osumc.edu)
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
Recruiting patients with:
- Planned LAAC procedure using the Watchman FLX Pro device
- Suitable for all protocol defined drug regimens
- LVEF 30% or above
CT vs TEE Post-LAAC
Dr. Houmsse (Mahmoud.Houmsse@osumc.edu)
Non-randomized trial to compare Cardiac CT with TEE to evaluate Watchman FLX LAA Occluder Device Characteristics
Recruiting patients with:
- Planned LAAC procedure using the Watchman FLX Pro device
- eGFR of 30 or above
EMPOWER
Dr. Patel (Vaiibhav.Patel@osumc.edu)
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%
CORCINCH
Dr. Boudoulas/Dr. Patel (Konstantinos.Boudoulas@osumc.edu; Vaiibhav.Patel@osumc.edu)
Randomized trial to assess the safety and effectiveness of the AccuCinch Ventricular Restoration System in HFrEF patients with symptomatic heart failure
Recruiting patients with:
- LVEDD greater than or equal to 55mm
- LVEF 20% - 40%
APOLLO
Dr. Boudoulas/Dr. Whitson (Konstantinos.Boudoulas@osumc.edu; Bryan.Whitson@osumc.edu)
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
Recruiting patients with:
- 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%
EMPOWER
Dr. Patel (Vaiibhav.Patel@osumc.edu)
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%
ACCLAIM-Lp(a)
Dr. Milks (Wesley.Milks@osumc.edu)
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
Recruiting patients with:
- Lp(a) > 175 nmol/L (screening lab)
- Established ASCVD with event/revasc OR at risk for first CV event
CASCADE FH Registry
Dr. Milks (Wesley.Milks@osumc.edu)
National registry for patients with familial hypercholesterolemia
Recruiting patients with:
- Familial hypercholesterolemia
PEERLESS II
Dr. Gumina (Richard.Gumina@osumc.edu)
Randomized trial comparing FlowTriever System plus anticoagulation versus anticoagulation alone in patients with intermediate-risk acute PE
Recruiting patients with:
- Intermediate risk PE with symptom onset in the last 14 days
- RV dysfunction
- Appropriate for catheter-based intervention
COSIRA
Dr. Lilly (Scott.Lilly@osumc.edu)
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
Recruiting patients with:
- Refractory angina (CCS class II – IV) and no therapeutic options
- LVEF greater than or equal to 30%
EXACT II
Dr. Boudoulas (Konstantinos.Boudoulas@osumc.edu)
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
Recruiting patients with:
- Refractory angina (CCS class II – IV) and no therapeutic options
- LVEF greater than or equal to 25%
CLASP TR CAS
Dr. Boudoulas/Dr. Lilly (Konstantinos.Boudoulas@osumc.edu; Scott.Lilly@osumc.edu)
Continued access, single arm trial evaluating the safety and effectiveness of the PASCAL Transcatheter Valve Repair System for the treatment of severe tricuspid regurgitation
Recruiting patients with:
- Symptomatic, severe TR
- Intermediate or greater risk for tricuspid valve surgery
- LVEF greater than or equal to 25%
RADIATE VT
Dr. Brownstein (Jeremy.Brownstein@osumc.edu)
Randomized trial evaluating cardiac radioablation versus repeat catheter ablation for patients with high-risk refractory Ventricular Tachycardia
Recruiting patients with:
- High risk refractory VT
- Clinical indication for a repeat CA procedure for scar-mediated VT
- Failed amiodarone therapy or intolerant to amiodarone