Clinical Research
Patients in our trials are pioneering the next generation of heart and vascular treatments.
Advancing new treatments and improving patient care through innovative research
At the WVU Heart and Vascular Institute, patients benefit from the most advanced heart and vascular treatments available. Our experts also lead pioneering clinical trials and research studies that drive the future of cardiovascular care in West Virginia and the surrounding region.
Clinical Trials
Arise II
The ARISE II trial evaluates the safety and effectiveness of the GORE® Ascending Stent Graft for treating lesions in the ascending aorta and aortic arch.
Cryptic
This study compares cryopreserved platelets to standard liquid-stored platelets to determine which is more effective at controlling blood loss in patients undergoing cardiopulmonary bypass surgery.
CKJX839, Novartis, Balla
The CKJX839 study is evaluating whether inclisiran can help prevent major cardiovascular events in high-risk patients with no prior history of heart disease.
Confirm 2
The CONFIRM2 study is the largest cardiovascular outcomes study of its kind, designed to better understand how heart imaging findings relate to patient symptoms and long-term health. This international registry uses both past and current data to evaluate how coronary CT angiography (CCTA) can help predict major cardiac events and outcomes in patients with chronic coronary artery disease (CAD).
Conformal
Temporarily Paused
This study evaluates the safety and effectiveness of the CLAAS® device compared to the WATCHMAN® and Amulet™ devices for left atrial appendage closure in patients with non-valvular atrial fibrillation. Eligible participants are randomly assigned to receive one of the devices and are followed for five years after implantation.
CS-15
This multi-center, open-label study evaluates the safety and tolerability of olezarsen in up to 700 participants with severe hypertriglyceridemia (SHTG).
Participants from previous studies (ISIS 678354-CS5 or CS6) may join this trial, which includes a 31-day qualification period, a 53-week treatment phase with olezarsen, and a 13-week follow-up after treatment.
CTSN EMPRO
This prospective, multicenter, randomized trial evaluates the safety and effectiveness of the CardioGard embolic protection cannula compared to a standard cannula.
Enrollment will last approximately 30 months, with patients followed for 12 months after their procedure.
CTSN PACeS
This study aims to evaluate the effectiveness and safety of adding oral anticoagulation (OAC) to antiplatelet therapy for patients who develop new-onset atrial fibrillation after coronary artery bypass graft (CABG) surgery.
Patients with qualifying post-operative atrial fibrillation (POAF) who choose not to be randomized can join a parallel registry to track their treatment and risk factors. They will also be invited to complete a brief survey.
CTSN PRIMARY
This prospective, multicenter, randomized trial compares mitral valve transcatheter edge-to-edge repair (TEER) with surgical repair in patients with primary degenerative mitral regurgitation.
Conducted across the U.S., Canada, Germany, and the U.K., the trial allows use of any TEER devices legally approved in each country.
CTSN STRIVE
COVID-19 can trigger an overactive immune response, and immune modulation has been shown to improve outcomes in hospitalized patients. This trial evaluates whether early intensification of immune modulation with abatacept plus standard care improves recovery compared to placebo plus standard care in patients requiring low-flow oxygen. If disease progresses, both groups receive intensified immune modulation as part of standard care.
CY 6033
This clinical trial is studying how aficamten compares to placebo in improving quality of life, exercise capacity, and clinical outcomes for patients with non-obstructive hypertrophic cardiomyopathy.
DISCOVER
This registry collects data on patient characteristics, treatment patterns, and outcomes in the U.S. and Europe for people with symptomatic obstructive hypertrophic cardiomyopathy (HCM). It includes patients receiving mavacamten, other treatments, or no treatment due to intolerance or prior treatment failure.
U.S. Sub-Study: Focuses on evaluating the safety of mavacamten in real-world clinical practice.
Europe Sub-Study: Evaluates both the effectiveness and safety of mavacamten in routine care.
ECP
The Impella ECP Study is a prospective, multicenter, single-arm trial evaluating major cardiovascular and cerebrovascular events (MACCE) in adults undergoing high-risk percutaneous coronary intervention using the Impella ECP device.
This also applies to the Impella ECP Continued Access Protocol.
EXPAND II TAVR
This international, multicenter, prospective randomized study compares outcomes in patients receiving transcatheter aortic valve replacement (TAVR) using either the Evolut PRO+ or Evolut FX System, alongside guideline-directed medical therapy (GDMT), versus GDMT alone.
ICE-AF, Atricure
The primary goal of this study is to assess the safety and effectiveness of the AtriCure CryoICE system for performing the Cox-Maze III procedure, combined with Left Atrial Appendage (LAA) exclusion using the AtriClip device.
Principal Investigator: Niv Ad, MD
KJX839
This study evaluates the efficacy, safety, tolerability, and quality of life impact of inclisiran (KJX839) versus placebo, alongside optimized lipid-lowering therapy, in participants with hypercholesterolemia.
LeAAPS
This prospective, randomized, multicenter, multinational, blinded trial evaluates whether left atrial appendage exclusion (LAAE) during cardiac surgery can better prevent ischemic stroke and systemic arterial embolism in patients at risk for atrial fibrillation and stroke.
MAGICAL ISR
This prospective, multicenter, randomized trial evaluates the safety and effectiveness of the MagicTouch™ sirolimus-coated balloon for treating coronary drug-eluting stent in-stent restenosis (ISR).
About 492 patients with prior DES implantation and ISR lesions undergoing PCI will be randomized 2:1 to receive either the MagicTouch™ balloon or plain old balloon angioplasty (POBA). The study will take place across up to 50 U.S. sites.
OPTIMAL
This study aims to evaluate the safety and patient compliance of starting treatment with intravenous (IV) antibiotics followed by oral antibiotics for uncomplicated IV drug-associated (IVDA) endocarditis.
Endocarditis is a serious infection that typically requires long hospital stays and extended IV antibiotic treatment, which can be costly and challenging for patients.
PROACTIVE 2
The PROACTIVE-HF-2 Trial is a prospective, multicenter, open-label, randomized study evaluating the safety and effectiveness of the Cordella™ Pulmonary Artery Sensor System in patients with NYHA Class II-III heart failure.
The study includes five groups:
- Randomized arm to assess safety and efficacy in NYHA Class II patients
- Treatment, active control, and crossover arms for different comparative analyses
- Single-arm study assessing the sensor combined with clinician-directed patient self-management in NYHA Class III patients
- Separate clinician management arm
Proactive HF
This prospective, open-label, single-arm, multicenter trial evaluates the safety and effectiveness of the Cordella™ Pulmonary Artery Sensor System in patients with NYHA Class III heart failure, compared against a predefined performance goal.
ProTECT
The ProTECT registry is a multicenter, observational study tracking patients undergoing heart transplant who receive Prospera testing as part of their routine care. Patients are enrolled within 60 days of their transplant and followed over time.
PROTECT IV
Clinical Trial to Evaluate the Safety and Effectiveness of the Tendyne Transcatheter Mitral Valve System for Symptomatic Mitral Regurgitation (SUMMIT Trial)
This prospective, controlled, multicenter study includes four patient cohorts:
- Randomized Cohort: Patients are randomized 1:1 to receive either the Tendyne Transcatheter Mitral Valve System or the MitraClip system for symptomatic moderate-to-severe or severe mitral regurgitation within approved MitraClip indications.
- Non-repairable Cohort: Patients not suitable for mitral valve surgery or MitraClip repair receive the Tendyne device.
- Severe Mitral Annular Calcification (MAC) Cohort: Patients with symptomatic mitral valve disease due to severe MAC, at high surgical risk, receive the Tendyne device.
- Severe MAC Continued Access Protocol (MAC CAP): Continuation of the Severe MAC cohort.
The trial’s objective is to assess the safety and effectiveness of the Tendyne system compared to MitraClip, and its use in patients with severe MAC who are ineligible for surgery. Participants will be evaluated at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually for up to 5 years.
REPAIR-MR
This randomized controlled trial compares clinical outcomes of the MitraClip™ device versus surgical repair in patients with severe primary mitral regurgitation (MR) who are at moderate surgical risk and considered candidates for mitral valve repair by their local heart team.
RESPONDER-HF
This multicenter, prospective, randomized, double-blind, sham-controlled trial evaluates the Corvia Atrial Shunt device. After a supine bicycle exercise hemodynamic assessment and sedation, eligible patients are randomized 1:1 to either the treatment or control group.
- Treatment group: Undergo a trans-septal puncture guided by fluoroscopy and echocardiography to implant the Corvia Atrial Shunt.
- Control group: Receive sham procedures involving imaging of the atrial septum and left atrium without device implantation.
All patients have femoral venous access placed and will be followed at set intervals for 5 years. Patients are unblinded after their 24-month follow-up.
SMART
This trial aims to compare the safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in patients with a small aortic annulus and symptomatic severe native aortic stenosis.
SPYRAL AFFIRM
This single-arm interventional study evaluates the long-term safety, effectiveness, and durability of the Symplicity Spyral system in patients treated with renal denervation. The study also collects follow-up data from eligible patients previously treated in the SPYRAL PIVOTAL, SPYRAL HTN-OFF MED, and SPYRAL HTN-ON MED studies.
STEMI-DTU
This study evaluates whether using the IMPELLA® CP System for 30 minutes before catheterization can better protect the heart from damage caused by a heart attack compared to the current standard of care.
SUMMIT
Clinical Trial to Evaluate the Safety and Effectiveness of the Tendyne Transcatheter Mitral Valve System for Treating Symptomatic Mitral Regurgitation
Research Faculty
Kimberly Quedado, PhD
J.W. Awori Hayanga, MD, MPH
