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:

ALLIANCE

Principal investigator: Amit Vora, MD and David Loran, MD

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

Research Nurse: Brittany Mashuda, RN mashudabd@upmc.edu

APOLLO

Principal investigators: Amit Vora, MD and Mubashir Mumtaz, MD

The purpose of this study is to evaluate the safety and efficacy of Medtronic Intrepid™ TMVR System in patients with moderate-to-severe or severe symptomatic mitral regurgitation who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.

Research Nurse: Dawn MacFarlane, LPN macfarlanedm@upmc.edu

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

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

C-Guardians

Principal investigator: William Bachinsky, MD

The objective of this pivotal study is to evaluate the safety and efficacy of the CGuard™ Carotid Stent System when used to treat symptomatic and asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting.

Research Nurse: Eric Diehl, RN diehles@upmc.edu

Disrupt BTK II

Principal investigator: William Bachinsky, MD

The objective of this study is to assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries.

Research Nurse: Kathy Retzlaff, RN retzlaffkl@upmc.edu

EvolutTM EXPAND II 

Principal investigator:  Hemal Gada, MD and Atizazul Mansoor, MD

The study is designed to demonstrate the safety and effectiveness of the Medtronic TAVR system to include patients with moderate, symptomatic aortic stenosis.

Research Nurse: Brittany Mashuda, RN mashudabd@upmc.edu

Peerless RCT

Principal investigator: Amit Vora, MD

This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System compared to Catheter-Directed Thrombolysis (CDT) for acute intermediate-high-risk pulmonary embolism (PE), and includes a non-randomized cohort of up to 150 subjects with an absolute contraindication to thrombolytics.

Research Nurse: Eric Diehl, RN diehles@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 ShortCut Study

Principal investigator:  Hemal Gada, MD

The purpose of this study is to assess the safety and effectiveness of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets, and to demonstrate coronary artery ostia patency following leaflet split, in patients who are at risk for TAVR-induced coronary artery ostium obstruction following a ViV procedure.

Research nurse: Brittany Mashuda, RN mashudabd@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

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