The WVU Heart and Vascular Institute is a leader in cardiovascular care and research in West Virginia. Our patients have access to the most current procedures and treatments. The experts at the WVU Heart and Vascular Institute conduct ongoing heart and vascular clinical trials and research studies.

For more information about these studies, contact Annina Guzek, RN, at 304-293-0615 or annina.guzek@wvumedicine.org.

Current Recruiting Studies

CT SURGERY

Tendyne SUMMIT (enrolling)
PI: Dr. Vinay Badhwar
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation. Prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation.
HVI is only site in WV.

Tendyne MAC (follow-up)
PI: Dr. Vinay Badhwar
Feasibility study of the Tendyne Mitral Valve System in Mitral Annular Calcification

HVI is only site in West Virginia

CTSN PACeS (enrolling)
PI: Dr. Vinay Badhwar
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG

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.

Funding is from the NIH. HVI is only site in West Virginia

Cryolife ProAct (enrolling)
PI: Dr. Vinay Badhwar
Clinical Trial of the On-X® Valve Using Low Dose Anticoagulation
This is a longitudinal, randomized (randomization to occur at the 3 month follow-up) study comparing the On-X valve on low dose anticoagulation (test group) to concomitant control groups of On-X valves receiving standard Coumadin/aspirin therapy, and also to FDA objective performance criteria (OPC).

HVI is only site in WV.

Atricure ICE-AFIB (enrolling)
PI: Dr. Vinay Badhwar
AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment during Concomitant On-Pump Endo/Epicardial Cardiac Surgery

The primary objective of this study is to evaluate the safety and effectiveness of the AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.

HVI is only site in WV and PA.


THORACIC SURGERY

Roman (enrolling)
PI: Dr. Ghulam Abbas
Prospective, Randomized, Multicentric Study on Videothoracoscopic (VATS) vs Robotic Approach for Lobectomy or Anatomical Segmentectomy in Patients Affected by Early Lung Cancer
This is a prospective, randomized, multicenter study on 300 patients (150 VATS lobectomies and 150 robotic lobectomies) affected by early stage lung cancer.

Invite only trial of top centers. HVI is only site in West Virginia


VASCULAR SURGERY

Bolton Relay Pro-T (enrolling)
PI: Dr. Luke Marone
A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects with Traumatic Injury of the Descending Thoracic Aorta. A prospective, multicenter, non-blinded, non-randomized study of the RelayPro Thoracic Stent-Graft in subjects with traumatic injury of the DTA. The primary objective is all-cause mortality at 30 days post-procedure.

Lantheus Definity (enrolling)
PI: Dr. Abbas Ali
Angiographic and Clinical Evaluation of DEFINITY Enhanced Ultrasound Guided Symptomatic Lower Extremity Peripheral Artery Disease Intervention. To investigate the use of DEFINITY enhanced ultrasound to guide peripheral artery disease assessment and intervention compared to using iodine based contrast and catheter angiography alone.

Unique trial that is investigator initiated here at HVI.

EKOS Knoc-Out PE (enrolling)
PI: Dr. Luke Marone
Retrospective and Prospective International EKoSoNic® Registry of the Treatment and Clinical OUTcomes of Patients with Pulmonary Embolism. To understand the APT treatment protocol used as SoC across institutions and document changes in practice following the OPTALYSE PE study results. To describe the effects of varied APT protocols on long-term patient outcomes.

Ranger SFA (follow-up)
PI: Dr. Luke Marone
A 3:1 Randomized Trial Comparing the Boston Scientific RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA). To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA).


CARDIOLOGY – INTERVENTIONAL

Abbott Amulet (follow-up)
PI: Dr. Bryan Raybuck
AMPLATZER Amulet Left Atrial Appendage Occluder

To evaluate the safety and effectiveness of the Amulet device by demonstrating its performance is non-inferior to the commercially available Boston Scientific LAA closure (LAAC) device (Control) in subjects with non-valvular atrial fibrillation.

HVI is only site in West Virginia

Abiomed cVAD (enrolling)
PI: Dr. Chalak Berzingi/Dr. Ramesh Daggubati
The Global cVAD Study is an ongoing, observational, multicenter, records review of patients receiving the ABIOMED, Inc. hemodynamic support device(s).

The Global cVAD Study is an ongoing, observational, multicenter, records review of patients receiving the ABIOMED, Inc. hemodynamic support device(s). In order to best represent real-world practice, patients receiving support from an ABIOMED, Inc. hemodynamic support device(s) at participating institutions will be included in the study without preselection.

Medtronic Safe-STEMI (enrollig)
PI: Dr. Chalak Berzingi
Study of Access Site for Enhancing PCI in STEMI for Seniors (SAFE-STEMI for Seniors)

To simultaneously address four potential advances in STEMI care for patients at least 65 years old.

Abiomed STEMI-DTU Pivotal (enrolling)
CO-PI’s: Dr. Jason Moreland & Dr. Chalak Berzingi
Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Pivotal Trial. To demonstrate the safety and effectiveness of primary Left Ventricular unloading and a thirty minutes delay to reperfusion vs. current standard of care in reducing infarct size and heart failure-related clinical events in patients presenting with anterior ST-Elevation Myocardial Infarction.

Boston Scientific Option (start-up)
PI: Dr. Bryan Raybuck
Comparison of Anticoagulation with Left Atrial Appendage Closure after AF Ablation

The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.

Osprey DyeVert Registry (enrolling)
PI: Dr. Jason Moreland
DyeVertTM System Use for Contrast Monitoring and Minimization in At-Risk Patients Undergoing Angiography Procedures: A Real-World Registry (DyeMINISH Registry)

To evaluate ongoing safety and performance of DyeVert Systems during standard clinical use in a real-world patient population.


CARDIOLOGY – NON-INVASIVE

Aegerion Lower (enrolling)
PI: Dr. Anthony Morise
Lomitapide Observational Worldwide Evaluation Registry

The registry is designed to evaluate the long-term safety and effectiveness of lomitapide in clinical practice.

GE Aurora (closed)
PI: Dr. Partho Sengupta
A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease

Assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz (18F) Injection
PET MPI in the detection of significant CAD, as defined by ICA, in patients with suspected
CAD.

University of Florida WARRIOR (enrolling)
PI: Dr.Ifran Zeb
Women’s Ischemia Trial to Reduce Events in Non-Obstructive CAD

This study is being conducted to determine whether aggressive medication treatment to modify risk factors in women with coronary arteries showing no severe obstruction but with cardiac symptoms (i.e., chest pain) will reduce their likelihood of dying, having a heart attack, stroke or being hospitalized. The results of this study will provide the data necessary to inform future guidelines regarding how best to treat this growing population of women, and ultimately improve their cardiac health and quality of life and reduce health-care costs.

Amgen CV Mobius (start-up)
PI: Dr. Anthony Morise
The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS)

Evaluate the real-world effectiveness of PCSK9is to reduce cardiovascular events in routine practice in a prospective cohort of adults presenting with a recent ASCVD event and/or revascularization procedure.


CARDIOLOGY – HEART FAILURE

PreCardia Venus HF (enrolling)
PI: Dr. George Sokos
SUPERIOR VENA CAVAL OCCLUSION IN SUBJECTS WITH ACUTE DECOMPENSATED HEART FAILURE- AN EARLY FEASIBILITY STUDY

The objective of this early feasibility study is to evaluate the safety and performance of the preCARDIA System for Superior Vena Caval (SVC) intermittent mechanical occlusion as a therapeutic approach in significantly congested subjects with Acute Decompensated Heart Failure (ADHF), who are not diuresing adequately.

Sanofi SOLOIST (enrolling)
PI: Dr. George Sokos
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of SOtagLiflozin on Clinical Outcomes in HemodynamIcally STable Patients with Type 2 Diabetes POST Worsening Heart Failure

To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity (composite of CV death or hospitalization for heart failure [HHF]) compared to placebo in hemodynamically stable patients with type 2 diabetes (T2D) and heart failure (HF) with a left ventricular ejection fraction (LVEF) <50%, after admission for worsening heart failure
(WHF). To demonstrate that sotagliflozin reduces CV mortality and morbidity (composite of CV death or HHF) compared to placebo in hemodynamically stable patients with T2D and heart failure, irrespective of LVEF, after admission for WHF (total patient population).

Astra Zeneca Deliver 1 (enrolling)
PI: Dr. Christopher Bianco
An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients with Heart Failure with Preserved Ejection Fraction (HFpEF)

To determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the composite of CV death and HF events (hospitalisation for HF or urgent HF visit) in patients with HF and preserved systolic function.

Abbott CardioMEMS (follow-up)
PI: Dr. George Sokos
Evaluate the use of the CardioMEMS HF System in patients with Class III Heart Failure in a commercial setting.

The purpose of this Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with Class III Heart Failure in a commercial setting.

Amgen Galactic (follow-up)
PI: Dr. George Sokos
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction

To evaluate the effect of treatment with omecamtiv mecarbil (OM) compared with placebo on the time to cardiovascular (CV) death or first HF event, whichever occurs first, in subjects with chronic HF with reduced ejection fraction (HFrEF) receiving standard of care (SoC) therapy.

Janssen A-DUE (enrolling)
PI: Dr. Marco Caccamo
Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy

To evaluate the effect of the M/T FDC vs macitentan 10 mg alone on PVR at EDBT in subjects with symptomatic WHO Group 1 PAH who are PAH-specific treatment-naïve or are currently being treated with an ERA as monotherapy. To evaluate the effect of the M/T FDC vs tadalafil 40 mg alone on PVR at EDBT in subjects with symptomatic WHO Group 1 PAH who are PAH-specific treatment-naïve or are currently being treated with a PDE-5i as monotherapy.

Relypsa/Syneos Health Diamond Vifor (start-up)
PI: Dr. Marco Caccamo
A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)

To determine if patiromer treatment of subjects who developed hyperkalemia while receiving RAASi medications will result in continued use of RAASi medications in accordance with heart failure (HF) treatment guidelines and thereby decrease the occurrence of the combined endpoint of cardiovascular (CV) death and CV hospitalization events compared with placebo treatment.


CARDIAC CRITICAL CARE

Astellas Icon AKI (start-up)
PI: Dr. Paul McCarthy
A Phase 2 Proof of Concept, Double-blind, Randomized, Placebocontrolled Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery

To evaluate the efficacy of postsurgery treatment with ASP1128 in subjects at risk for acute kidney injury (AKI) following coronary artery bypass graft (CABG) and/or valve surgery.

HVI only one in WV.


CARDIAC ANESTHESIOLOGY

Merck Sugammadex (enrolling)
PI. Dr. Matthew Ellison
Role of Sugammadex as Reversal Agent in Patients Extubated Immediately After Isolated Coronary Artery Bypass Grafting (CABG) Surgery

The purpose of this study is to examine whether the use of Sugammadex will reduce time from reversal to extubation and improve other post extubation outcomes in Coronary artery bypass grafting (CABG) patients.


For more information about these studies, contact Annina Guzek, RN, at 304-293-0615 or annina.guzek@wvumedicine.org.