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UPMC Clinical Trials For Cardiac Care in Central Pa.

UPMC has long been a leader in cardiovascular care, with a rich history in clinical research and innovation.

At the UPMC Heart and Vascular Institute, our patients benefit from having access to some of the most current and promising procedures and medications.

Our expertise in diagnosing and treating a large and diverse volume of patients, along with our commitment to advancing scientific discovery, has helped us develop a very strong catalog of research on heart and vascular diseases.

Specifically, in Central Pa., our team of experts are currently engaged in the following trials:

LIFE BTK

Principal investigator:  William Bachinsky, MD

The trial is a prospective, randomized controlled clinical trial comparing Esprit BTK to percutaneous transluminal angioplasty. The study objective is to evaluate the safety and efficacy in CLI patients with up to two lesions in separate infrapopliteal vessels.

Research nurse: Gretchen Meise, RN  meisegc@upmc.edu


SMART Trial

Principal investigator:  Hemal Gada, MD

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.

Research nurse: Anita Todd, RN toddag@upmc.edu


AGENT IDE Study

Principal investigator:  William Bachinsky, MD

This trial is designed to assess the safety and effectiveness of the Agent Paclitaxel coated PTCA Balloon Catheter compared to a balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26mm in length (by visual estimate) in a native coronary artery 2.0mm to 4.0mm in diameter.

Research nurse: Gretchen Meise, RN  meisegc@upmc.edu


REPAIR MR Study

Principal investigator:  Mubashir Mumtaz, MD

The objective of this randomized controlled trial (RCT) is 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.

Research nurse: Anita Todd, RN toddag@upmc.edu 


The Target BP I Trial

Principal investigator:  William Bachinsky, MD

The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.

Research nurse: Gretchen Meise, RN  meisegc@upmc.edu


The CATALYST Trial

Principal investigator:  Hemal Gada, MD

The purpose of the study is to analyze Atrial Fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants. Prospective, randomized, controlled, unblinded, multicenter clinical trial of the Amplatzer Amulet device in patients with non-Valvular atrial fibrillation who are increased risk for cardioembolic events.  

Research nurse: Anita Todd, RN toddag@upmc.edu


CHAMPION-AF Study

Principal investigator:  Chinmay Patel, MD

The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

Research nurse: Anita Todd, RN toddag@upmc.edu


FARAPULSE ADVENT Trial

Principal investigator:  Chinmay Patel, MD

This is a prospective, adaptive, multi-center, randomized safety and effectiveness pivotal study comparing the FARAPULSE Pulsed Field Ablation System with standard of care ablation with force-sensing RF catheters and cryoballoon catheters indicated for the treatment of PAF.

Research nurse: Gretchen Meise, RN  meisegc@upmc.edu


PERFORMANCE II (CSP-1400)

Principal investigator:  William Bachinsky, MD

A prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP System for the treatment of carotid artery stenosis in subjects at elevated risk for adverse events following carotid endarterectomy (CEA). The Neoguard IEP system is a 3-in-1 carotid stent delivery system consisting of angioplasty balloon and constrained by an outer sheath. 

Research nurse: Gretchen Meise, RN meisegc@upmc.edu


RELIEVE-HF Trial

Principal investigator:  Hemal Gada, MD

The study is a prospective, multi-center, 1:1 randomized, patient and observer blinded trial, with a Shunt Treatment arm and a non-implant Control arm. The objective is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System to improve clinical outcomes in a certain high-risk subset of symptomatic patients suffering from heart failure. 

Research nurse: Anita Todd, RN toddag@upmc.edu


The Early Feasibility Study of the Intrepid™ TMVR Transseptal System

Principal investigator:  Hemal Gada, MD

This trial is a multi-center, global, prospective, non-randomized, interventional, and pre-market. All subjects enrolled will receive the study device.

Research nurse:  Anita Todd, RN toddag@upmc.edu


Clinical Study of the BioVentrix Revivent TCTM System for Treatment of the Left Ventricular Aneurysms 

Principal investigator:  Roberto Hodara, MD

A prospective, multi-center, dual-arm pivotal study with 2:1 study vs. active concurrent control group allocation ratio. The purpose of the study is to demonstrate the safety and effectiveness of the BioVentrix Revivent TC System for the treatment of LV antero-septal aneurysms/scars in patients with symptomatic heart failure.

Research nurse: Gretchen Meise, RN meisegc@upmc.edu


SPYRAL HTN – ON MED

Principal investigator:  William Bachinsky, MD

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.

Research nurse: Gretchen Meise, RN meisegc@upmc.edu


EARLY TAVR Trial (2016-07)

Principal investigator:  Hemal Gada, MD

This is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3/SAPIEN 3 Ultra THV or CS. Patients will be stratified by whether they are able to perform a treadmill stress test or not. In addition, patients who are screened for enrollment but have a positive stress test will be followed in a registry to collect data on a subsequent treatment and mortality, as applicable. 

Research nurse: Anita Todd, RN toddag@upmc.edu

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