Research and Clinical Trials at the UPMC Heart and Vascular Institute

AID MI Study

PI: Samir Saba, MD
Research Coordinator: Eric Pasquantonio

The purpose of this research study is to determine and understand the clinical outcomes in patients following an AMI with cardiac monitoring using the Confirm RX Insertable Cardiac Monitor or Abbott equivalent commercially available insertable cardiac monitor. Your involvement in the trial will be for two years following randomization and the trial will enroll approximately 200 patients. 

• Looking for patients 18 years or older that have experienced AMI (STEMI and NSTEMI) and are expecting hospital discharge within 7 days of AMI. The patient must be willing to give written informed consent and receive ICM insertion within 21 days of index AMI.
• Follow-up will be done at 30 days, 90 days, 12 months, and 24 months after enrollment. All follow-up visits could be performed remotely by phone call and remote device interrogation (if applicable) or in person at the outpatient clinic.
• Questionnaires and surveys will be completed by the patient during the follow-up period. 
• There will be two treatment groups randomly assigned. 100 patients will be assigned to a control group (no device) and the other 100 patients will be assigned to receive the Insertable Cardiac Monitor. 
• Expanding enrollment to our UPMC Hamot campus; will expand to Altoona eventually.
  

Reach out to Eric, RN at 412-647-8210 or pasquantonioej@upmc.edu, or Jessica Caratelli at 412-246-5997 or daughtersj@upmc.edu for more details.  

Catalyst

PI: Samir Saba, MD
Research Coordinator: Susan Sweeny

The CATALYST Trial is studying the Amplatzer™ Amulet™ Left Atrial Appendage Occluder in patients with non-valvular atrial fibrillation who are either on a non-vitamin K antagonist oral anticoagulant (NOAC) blood thinner, or eligible to take a NOAC.

WHO CAN PARTICIPATE IN THE CATALYST TRIAL COMPARING LEFT ATRIAL APPENDAGE OCCLUSION TO NOAC THERAPY? Both men and women can participate.

You may qualify if: 

• You have been diagnosed with non-valvular atrial fibrillation and are at an increased risk for ischemic stroke 
• You have a CHA2DS-VASc score of 2 or greater in males, and 3 or greater in females
• Your doctor believes you are eligible for NOAC therapy 
• You are willing and able to complete the study follow-up visits 
• You are willing to receive an Amulet Left Atrial Appendage Occluder if randomized to that therapy

Please reach out to Susan Sweeny, RN, for details at 412-864-1420 or sweenysm@upmc.edu. 

LAAOS-4

PI: Sandeep Jain, MD
Research Coordinator: Eric Pasquantonio

You are being invited to take part in a research study called The Fourth Left Atrial Appendage Occlusion Study: (LAAOS-4). Taking part in this study is completely voluntary. The purpose of the LAAOS-4 study is to determine if closure of the left atrial appendage using a closure device called the WATCHMAN™, in addition to taking oral anticoagulant medications, is more effective at reducing strokes and blood clots in your body, than taking oral anticoagulant medications on their own.

Please reach out to Eric Pasquantonio, RN at 412-647-8210 or pasquantonioej@upmc.edu.

Left vs. Left RCT

PI: Krishna Kancharla, MD
Research Coordinator: Sherry Pellegrino

You are being invited to take part in this research study because you have a weak heart (heart failure). The electrical system of your heart muscle has many tiny cells that form a tree-like shape with small branches that run throughout the lower chambers of your heart. Your heart’s electrical system controls the timing of your heartbeat (by sending out electrical signals) and conducts electricity very fast through these tiny cells. We know that people with a weak heart and an abnormal heart beat can benefit from having a pacemaker. 

If you decide to take part in this study, you will be randomly assigned (like flipping a coin) to one of two treatments (A or B), both of which are standard of care heart pacing treatments:

• A. Pacing your heart from two locations in the left ventricle (lower left chamber of the heart)
• B. Pacing your heart from one of two other places in the heart (the “His” or the left bundle branch) which are parts of the normal electrical system

The purpose of this study is to compare side by side these two treatments and evaluate if one is better than the other. This study is under the oversight of the Food and Drug Administration (FDA) which means only devices and leads covered under their oversight will be used. 

Please reach out to Sherry Pellegrino, RN, for details at 412-647-8437 or pellegrinosl@upmc.edu. 

PIVATAL

PI: Krishna Kancharla, MD; David Kaczorowski, MD
Research Coordinator: Rachel Mcgargle; Susan Sweeny

Looking for patients with advanced cardiomyopathy (INTERMACS classification) and eligible for LVAD per HF clinical team who have had ICD w/remote monitoring in past and sustained VT or VF episode (>30 seconds in duration) in the past 5 years.

Reach out to Rachel, RN 412-864-0788,  mcgarglerd@upmc.edu; or Susan, RN 412-864-1420, sweenysm@upmc.edu for more information.    

PVC Imaging

PI: Sandeep Jain, MD
Research Coordinator: Susan Sweeny

The research study is being conducted to evaluate if imaging techniques can identify irregular heart rhythms with extra heart beats (PVCs) that would cause a cardiomyopathy.

The purpose of this study is to find out if we can determine if certain extra heart beats are bad for the heart and could cause the heart function to decline.

You are being invited to participate in a research study because you have an irregular heart rhythm with extra heart beats (PVCs).We are looking for patients with > or = 9.5% PVC’s who are likely to undergo PVC ablation and/or medical suppression of PVC’s.

If you have any potential candidates for the study, please contact Susan Sweeny, RN, at 412-864-1420 or sweenysm@upmc.edu

Assessment of Implantable CCM in the Heart Failure Group with Higher Ejection Fraction

PI: Brittany Palmer, MD

Research Coordinator: Traci McGaha (412) 692-4828

AIM HIGHER The study will evaluate the efficacy and safety of Cardiac Contractility Modulation (CCM) therapy in patients with symptomatic heart failure with a left ventricular ejection fraction ≥40 and ≤ 60% using the Optimizer Smart Mini System.

Please contact Traci McGaha 412-692-4828 (mcgahatl4@upmc.edu) or Brittany Palmer (palmerba2@upmc.edu).

CARDIAG Trial

PI: Prem Soman, MD

Research Coordinator: Christina Smith (412)-647-4463

CARDIAG evaluates the safety and effectiveness of Positron Emission Tomography (PET) Imaging to Diagnose Cardiac AL Amyloidosis. Age 18 or older, patients being considered for a possible diagnosis of cardiac amyloidosis. One visit for the PET scan and 2 follow up phone calls. Patient receives PET in addition to the standard diagnostic procedures. This study is being conducted to determine a rapid, less-invasive procedure for detecting cardiac amyloidosis. Patient also receives &250 USD for travel expenses.

PIVATAL

PI: Krishna Kancharla, MD; David Kaczorowski, MD

Research Coordinator: Rachel McGargle, RN; Susan Sweeny, RN

Looking for patients with advanced cardiomyopathy (INTERMACS classification) and eligible for LVAD per HF clinical team who have had ICD w/remote monitoring in past and sustained VT or VF episode (>30 seconds in duration) in the past 5 years.

Please contact Rachel, RN at 412-864-0788 (mcgarglerd@upmc.edu) or Susan, RN at 412-864-1420 (sweenysm@upmc.edu).

TRIUMPH-3

PI: Anita Saraf, MD

Research Coordinator: Marcy Gelman

Phase 3 study of LY3437943 (Retatrutide), a novel GLP-1/GIP/Glucagon receptor triagonist, to assess efficacy of weight loss and disease management in obese adults (BMI ≥35 kg/m2), with cardiovascular disease (prior myocardial infarction, prior ischemic or hemorrhagic stroke, PAD with intermittent claudication or ABI <0.85 at rest) or partial revascularization or amputation).  

Please contact Anita Saraf (sarafap@upmc.edu) or Marcy Gelman (gelmanms@upmc.edu). 

MEDTRACE Trial

PI: Prem Soman, MD

Research Coordinator: Christina Smith (412)-647-4463

MEDTRACE A Phase 3, Multicenter, Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered 15O-H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging 0-15 water PET, an agent that has been evaluated in over 4000 patients in Europe. This is the first phase 3 study in the US. The study involves just one visit for the PET scan and a f/u phone call.  Enrolling patients with NO known CAD, no history of MI, previous stents, CABG or Primary Myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy.  www.medtracepharma.com 

Empa-CHD

PI: Anita Saraf, MD

Research Coordinator: Shannon Janzef

Congenital heart disease patients (>18 years) with systemic RVs or single ventricle physiology will be treated with Empagliflozin (Jardiance 10 mg) for 1 year versus placebo. Randomized, double-blind trial. 

Please contact Anita Saraf at sarafap@upmc.edu or  Shannon Janzef at janzefsl@upmc.edu for further details.

IONIS

PI: Prem Soman, MD
Research Coordinator: Tracy Nicholson
A study of patients with transthyretin-mediated amyloid cardiomyopathy (ATTR CM). This phase 3 global, double-blind, randomized, placebo controlled study will assess the efficacy and safety of ION-682884.

Redwood

PI: Timothy Wong, MD
Research Coordinator: Jenny Whitehead
Looking for adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction. This multi-center, randomized, double blinded, placebo-controlled, dose-finding study of CK-3773274 will assess the:

• Safety and tolerability.
• Pharmokinentics.
• Pharmacodynamics.

MED TRACE

PI: Prem Soman, MD
Research Coordinator: Chrisse Smith

A Phase 3, Multicenter, Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered 15O-H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging 0-15 water PET, an agent that is approved and widely used in Europe. This is the first phase 3 study in the US. The study involves just one visit for the PET scan and a f/u phone call.  Enrolling patients with NO known CAD, no history of MI, previous stents, CABG or Primary Myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy.   

ABBOTT: Percutaneous MitraClip™ Device or Surgical Mitral Valve REpair in PAtients with PrImaRy Mitral Regurgitation who are Candidates for Surgery (REPAIR MR)

PI: Ibrahim Sultan, MD
Research Coordinator: Kristin Konopka
The purpose of this study is to evaluate the medical device called MitraClip™ Mitral Valve Repair System or the MitraClipTM system for an investigational use in patients with severe primary mitral regurgitation who are at moderate surgical risk. 

Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Risk Patients who have Severe, Symptomatic, Aortic Stenosis Requiring Aortic Valve Replacement - ENVISION

PI:  Ibrahim Sultan, MD
Research Coordinator: Stephanie Trbovich

Patients are being invited by your doctor to take part in this research study evaluating the investigational NavitorTM Transcatheter Aortic Valve Implantation (TAVI) System (Navitor Valve, Navitor Loading System and FlexNavTM Delivery System) because your doctor has determined that this transcatheter heart valve could be beneficial to you in treating your heart valve condition (aortic stenosis).    

 RISE II- Evaluation of the GORE® Ascending Stent Graft in the Treatment of Lesions of the Ascending Aorta

PI: Ibrahim Sultan, MD
Research Coordinator: Kristin Konopka 412-647-7271

This research study is looking at treating aortic diseases in the part of the aorta close to the heart called the ascending aorta. Treatment would be done with a new investigational medical device called the GORE® Ascending Stent Graft (ASG device). This novel device is less invasive as it is placed via a catheter in thru groin and not open surgery where chest cavity is opened.

There are 3 ways to be a part of this study:

1. If your aortic disease is only in the ascending part of your aorta that can be treated with the ASG device. This group of Subjects is called the Primary Arm.
2. If your aortic disease extends into your aortic arch and can be treated with the ASG device in combination with another stent graft device called the GORE® TAG® Thoracic Branched Endoprosthesis (TBE Device) and possibly another commercially available stent graft device called the Conformable GORE® TAG® Thoracic Endoprosthesis (Conformable TAG® Device). This group of Subjects is called the Secondary Arm.
3. If you are not eligible to be treated with the two investigational treatments, your doctor may recommend (and you may decide to have open surgery).  If you do have surgery, you could be enrolled in the open surgery cohort of the study. 

If you have open surgery, you will remain in the research study for one year so information can be collected on how your open surgery went and how you are doing. This group of Subjects is called the Surgical Follow-up Group.

TiGER-001 Study

PI: Ibrahim Sultan, MD
Research Coordinator: Kristin Konopka

Terumo Aortic manufactures endovascular (inside the blood vessel) grafts that are widely used to treat a number of different conditions. Terumo Aortic is funding the TiGER study to better understand how the study devices perform. You are being asked to take part because your doctor has decided that the most appropriate treatment for your condition is with a Terumo Aortic Relay®Pro Endovascular graft. 

Valved Graft Post-Market Clinical Follow-up Study

PI: Derek Serna-Gallegos
Research Coordinator: Gail Wallen

The purpose of this study is to evaluate the safety and effectiveness of Abbott Valved Graft devices used for surgical replacement for patients with a malfunctioning native or prosthetic aortic heart valve and ascending aorta pathology.

Apollo: Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System

PI: Ibrahim Sultan, MD
Research Coordinator: Missy Sanders Linger
This research project is testing a new device for mitral regurgitation without the need for open heart surgery. The device is a mitral valve replacement called the Intrepid Transcatheter Mitral Valve Replacement (TMVR) System. The purpose of this study is to learn if replacing the mitral valve without open-heart surgery is as safe and effective as standard mitral valve surgery in patients with similar medical conditions.

We're also working on this trial at UPMC in Harrisburg.

PI: Mubashir Mumtaz, MD
Research Coordinator: Courtney Rodgers

Optimize Pro: Optimize PRO TAVR Post-Market Study

PI: Ibrahim Sultan, MD
Research Coordinator: Stephanie Trbovich
The purpose of this Evolut™ PRO or EVOLUT™ PRO+ system study is to learn more about:

• How well this device works.
• The effects of following a particular set of steps when treating a patient with the device.

SUMMIT: Tendyne Mitral Valve System for Treating Symptomatic Mitral Regurgitation

PI: Ibrahim Sultan, MD
Research Coordinator: Missy Sanders Linger
The purpose of this trial is to assess a new investigational device called the Tendyne™ Mitral Valve System. The Tendyne Mitral Valve System is for the treatment of a diseased, damaged, or malfunctioning mitral valve. This trial will collect data on how safe and effective this device is to treat a leaking mitral valve compared to the commercially-available, FDA-approved MitraClip® System.

The MitraClip System consists of a delivery catheter and an implantable Clip that repairs the mitral valve by clipping the two leaflets together.

Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction (VNS 21-07)

PI: Natalie Sridharan, MD
Research Coordinators: Julia Wozniak
This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic iliofemoral venous obstruction. A maximum of 30 clinical sites across the U.S. will participate in the study. One hundred and sixty-five subjects are intended to be implanted with the GORE® VIAFORT Vascular Stent in this study, with a limit of 33 treated subjects per site. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1, 6, 12, 24, 36, 48, and 60 months post-treatment.

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study (AAA 24-01)

PI: Nathan Liang, MD
Research Coordinators: Judith Brimmeier
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. A maximum of 300 adult subjects will be enrolled at up to 60 U.S. centers, with a minimum of 70 subjects enrolled at study centers with no prior experience using the TAMBE Device. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 10 years post implant.

Nectero EAST System Clinical Study (stAAAble)

PI: Raymond Eid, MD
Research Coordinators: Judith Brimmeier
The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA. The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.

EndurAnt Stent Graft system vs ExcluDer endoprosthesis: a global, prospectiVe, rANdomized Clinical trial in sac rEgression (ADVANCE Trial)

PI: Nathan Liang, MD
Research Coordinators: Julia Wozniak
This is a post-market, prospective, interventional, global, multi-center, randomized, dual-arm clinical trial. The primary objective of this trial is to evaluate sac regression outcomes of the Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis in standard EVAR subjects. Subjects are randomized on a 1:1 basis to receive EVAR with either a Medtronic Endurant II/IIs Stent Graft Systems or Gore Excluder / Excluder Conformable AAA Endoprosthesis. Data is collected pre- and post-procedure at discharge, at 30 days, and once a year until the 5-year follow-up is completed. An estimate of 550 subjects (minimum 500) are enrolled at up to 100 sites globally, with the potential to extend enrollment up to 900 subjects based on predictive probability analysis to adequately achieve either non-inferiority or superiority for the primary endpoint.

Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy (REBIRTH) for Peripartum Cardiomyopathy

Trial PI: Dennis McNamara, MD, Agnes Koczo, MD, Malamo Countouris, MD
Research Coordinator: Donna Simpson, CRNP, MPH

The purpose of REBIRTH is to test whether drug called bromocriptine can strengthen the heart in women diagnosed with peripartum cardiomyopathy when compared to those not taking the drug while all remain on heart failure medication. Women who breastfeed may be eligible to be in an observational group that does not take study drug.

International Spontaneous Coronary Artery Dissection (iSCAD) Registry

Site PI: Agnes Koczo, MD

The goal of the iSCAD Registry is to facilitate the development of best practices and clinical guidelines for predicting and treating SCAD as well as preventing its recurrence. This survey-based observational study is recruiting participating with recent or remote history of SCAD. Interested patients can be referred to the SCAD Clinic at the Magee Women’s Cardiovascular Center for enrollment in the registry.

Participants must be:

• 18 years of age or older
• Diagnosis of SCAD or history of SCAD based on coronary angiography, either catheter-based or coronary CTA
• Cause of coronary dissection is spontaneous, not primary traumatic or iatrogenic dissection

Phenotyping Later Life Left Ventricular Remodeling among Women with a History of Preeclampsia

PI: Malamo Countouris, MD
Research Coordinator: Sila Yavan

This research study aims to show why women have these abnormal heart muscle changes in the 10 to 12 years after having their babies. To do this, we will use heart MRI and blood measurements. Heart MRI gives a more in-depth look at the heart muscle and blood measurements will identify the number of proteins and molecules in the blood to understand if these molecules contribute to the heart muscle changes found on heart MRI.  

This proposed study aligns directly with the mission of the American Heart Association to help women live healthier lives and prevent heart disease.

UPMC Magee-Womens Heart Program Postpartum Hypertension Clinic Registry

PI: Malamo Countouris, MD
Research Coordinator: Sila Yavan

Cardiovascular disease (CVD) is the leading cause of death for women, yet CVD mortality rates among young women remain alarmingly stagnant. Women with a history of hypertensive disorders of pregnancy (HDP) are at an increased risk for CVD compared with women who have uncomplicated pregnancies.

The purpose of this study is to develop a database to study postpartum women with a history of pregnancy complications including high blood pressure, hypertension, preeclampsia, and gestational hypertension. This study will allow us to collect data on women in the postpartum period who attend a postpartum hypertension clinic to guide best practices.

All patients in the Postpartum Hypertension Clinic older than 18 will be asked to complete a questionnaire on their medical history, demographic information, pregnancy history, symptoms, and knowledge about hypertensive disorders of pregnancy. These questionnaires will be used to build a database to study women with a history of hypertensive disorders of pregnancy. Participants who complete the survey will receive a $10 Amazon gift card (delivered electronically).

Participants must be above the age of 18 and have a diagnosis of a pregnancy complication including chronic hypertension, gestational diabetes, gestational hypertension, preeclampsia, heart failure, or peripartum cardiomyopathy. 

IPAC-Extension Study

PI: Dennis McNamara, MD
Magee Site Investigator: Agnes Koczo, MD
Clinical Research Coordinator: Ayse Keskin

This study will enroll patient with any history of peripartum cardiomyopathy (PPCM) (new or prior) as an extension of the Investigations of Pregnancy Associated Cardiomyopathy (IPAC) registry. This study aims to explore the impact of genetic variations on outcomes in PPCM. 

Participants will have blood drawn to look at DNA and possibly other biomarkers. Demographic information, medical (including pregnancy) history, and any cardiac imaging done on their heart for clinical purpose with be extracted from the electronic medical record from diagnosis and annually out to 5 years postpartum. 

If you have patients with new or prior diagnosis of PPCM who may be interested in the study, please contact Ayse Keskin (keskinas@upmc.edu) for further information.