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
Clinical Trials - Enrolling
ARISE II
Evaluation of the GORE® Ascending Stent Graft in the Treatment of Lesions of the Ascending Aorta.
The primary objective of ARISE II is to assess the safety and effectiveness of the GORE® Ascending Stent Graft device in the treatment of lesions involving the ascending aorta and aortic arch.
ARISE III
To assess the safety and effectiveness of the Ascending Stent Graft (ASG) device in the treatment of de novo Type A aortic dissections.
BACKBEAT
To evaluate the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.
CONFORM
The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the CLAAS device or the WATCHMAN or Amulet™ devices and will be followed for 5 years after device implant.
EMPRO
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
ENVISION
To evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality.
The trial will also evaluate the safety and effectiveness of the Navitor TAVI System in a valve-in-valve (ViV) application in patients with symptomatic heart disease due to failure of a surgical or transcatheter bioprosthetic aortic valve who are at high or greater surgical risk.
EXCLUDER
This study aims to confirm that the benefit-risk assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) remains positive in real-world use and to ensure the adequacy of the TAMBE Device training program.
HF-POLARIS
This study is being done to look at the safety and effect of NNC0487-0111 in people with Heart Failure with preserved Ejection Fraction (HFpEF) or Heart Failure with mildly reduced Ejection Fraction (HFmrEF) and excess body weight when compared to placebo. The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have HFpEF or HFmrEF and excess body weight. Participants will get NNC0487-0111 or placebo by injection once a week. Which treatment participants get is decided by chance. NNC0487-0111 is a new medicine that doctors cannot prescribe yet, but it has been tested in people before.
ICONIC-HF
To learn if the intravenous (IV) Iron treatment ferric derisomaltose helps in the treatment of chronic heart failure in people with iron deficiency. Researchers will compare treatment with ferric derisomaltose to no treatment with ferric derisomaltose. This will be done to see how well ferric derisomaltose works.
MOCA II
To validate the performance of the CoFI system in detecting Microvascular obstruction (MVO) in ST-segment elevation myocardial infarction (STEMI) subjects, as confirmed by Cardiac MRI.
PACeS
The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery.
All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey.
PRIMARY
This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany, Spain, and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.
PROACTIVE-HF-2
To demonstrate safety and efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure patients, where patients have daily access to Pulmonary Artery Pressure (PAP) data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy.
PROPEL
Galvanize Prospective/ Retrospective Pulsed Electric Field Device Registry
The goal of this observational registry is to assess the use and performance of Galvanize Pulsed Electric Field (PEF) technology in a real-world setting. The main questions it aims to answer are:
- PEF utilization and performance
- Monitor safety outcomes and inform future generation devices
Participants will undergo the PEF procedure and be followed per institutional standard of care.
PULSE-LHD
A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease [Activate Soon].
The goal of this clinical study is to evaluate the safety and efficacy of percutaneous pulmonary artery denervation with the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) associated with left heart disease (LHD). This randomized control trial will compare the investigational device (The Enhancor System) to control (medical therapy.)
STRIVE 002/IC-SARI
An International Observational Study of Adults With Acute Infection.
This observational study protocol describes collection of data and biospecimens from sites across the world for characterizing acute infections in hospitalized patients. The protocol is designed to study respiratory infections, infections outside the respiratory tract, established infectious diseases, and emerging infectious diseases. Data generated in this study will be used to efficiently characterize acute infectious diseases and plan future clinical trials.
Clinical Trials - Not Enrolling
CONTEMP-ICD
Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy in Contemporary Heart Failure Patients With a Low Risk for Arrhythmic Death.
The investigators aim to compare the risk of mortality of Non-implantable carioverter defibrillator (ICD) vs. ICD management in patients with heart failure with reduced ejection fraction (HFrEF).
CS15
CORE-OLE – A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants.
With Severe Hypertriglyceridemia (SHTG) The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with Severe Hypertriglyceridemia (SHTG)
CY6022
A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment With Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM).
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
DISCOVER-HCM
Deliver Insights in Hypertrophic Cardiomyopathy and Observational Outcomes in Real World: United States and European Prospective Registry Study.
This registry evaluates patient characteristics, real-world treatment patterns, and short- and long-term outcomes in a population of patients in the United States and Europe with symptomatic obstructive hypertrophic cardiomyopathy (HCM) who are receiving mavacamten, receiving other treatment for obstructive HCM, or not receiving treatment for obstructive HCM due to intolerance or failure of prior treatment.
ECP
Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention Impella ECP Continued Access Protocol.
The Impella ECP Study is a prospective, multi-center, single-arm study evaluating the rate of major adverse cardiovascular and cerebrovascular events (MACCE) with the Impella ECP device in adult patients undergoing elective or urgent high-risk percutaneous coronary intervention.
Evolut™ EXPAND TAVR II Pivotal Trial
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
HORIZON
A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With Established Cardiovascular Disease.
This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established Cardiovascular disease (CVD) and elevated lipoprotein(a), or Lp(a)
HORIZON-OLE
A Single Arm, Multicenter, Open-label Extension (OLE) Trial to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Participants Who Completed the Parent Lp(a)HORIZON Trial.
This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).
I-SPY COVID TRIAL
An Adaptive Platform Trial to Reduce Mortality and Ventilator Requirements for Critically Ill Patients.
The goal of this project is to rapidly screen promising agents, in the setting of an adaptive platform trial, for treatment of critically ill COVID-19 patients. In this phase 2 platform design, agents will be identified with a signal suggesting a big impact on reducing mortality and the need for, as well as duration, of mechanical ventilation.
KJX V1P
A Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Effect of Inclisiran on Preventing Major Adverse Cardiovascular Events in High-risk Primary Prevention Patients (VICTORION-1 PREVENT).
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
LeAAPS
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial.
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.
MAGICAL-ISR
A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis.
A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis.
PROACTIVE-HF
A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients.
This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella Pulmonary Artery (PA) Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).
PROTECT IV
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function.
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.
ProTECT
Prospera Test Evaluation in Cardiac Transplant.
The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled within 60 days of heart transplantation.
REPAIR MR
Percutaneous MitraClip Device or Surgical Mitral Valve REpair in PAtients With PrImaRy MItral Regurgitation Who Are Candidates for Surgery.
To compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.
RESPONDER-HF
Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction (EF) Heart Failure.
To confirm the clinical efficacy of the Corvia Atrial Shunt in patients with heart failure who have a left ventricular ejection fraction (LVEF) of ≥ 40% and elevated left-sided filling pressures, despite being on standard guideline-directed medical therapy (GDMT). This trial aims to assess whether the device can effectively reduce heart failure symptoms and improve patient outcomes.
SMART
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial.
The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis.
SUMMIT
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation.
To evaluate the safety and effectiveness of using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) was to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.
SPYRAL AFFIRM
The SPYRAL AFFIRM Global Clinical Study of Renal Denervation With the Symplicity Spyral Renal Denervation System in Subjects With Uncontrolled HypertensionHTN.
The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation.
Research Faculty
J.W. Awori Hayanga, MD, MPH
Kimberly Quedado, PhD
Misa Shaw, PhD