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.

ERADICATE-AF II

PI: Samir Saba, MD
Research Coordinator: Sherry Pellegrino

You are being asked to take part in this study because you have persistent or constant atrial fibrillation (a heart condition in which the upper chambers of your heart beat irregularly) and your doctor has determined that you need to undergo an catheter ablation procedure to treat your atrial fibrillation, a procedure that freezes heart tissue that is believed to be the cause of the arrhythmia. The purpose of this study is to see if performing an additional medical procedure called renal denervation during the standard catheter ablation for atrial fibrillation improves your atrial fibrillation.

• Looking for symptomatic persistent AF eligible for referral for PVI based on current guidelines (persistent AF defined as continuous > 7 days and up to 1 year); Study will randomize 1:1 to catheter ablation for AF alone by PVI (control group) or catheter ablation of AF by PVI with the addition of RDN (study group).

Reach out to Sherry Pellegrino, RN, at 412-647-8437 or pellegrinosl@upmc.edu.

FACT CRT

PI: Andrew Voigt, MD
Research Coordinator: Sherry Pellegrino

The purpose of this study is to validate how data collected using an echocardiogram, a heart imaging study, predicts response to cardiac resynchronization therapy provided by the CRT-D in individuals without the LBBB rhythm, and to identify new variables recorded from electrocardiograms (ECG) or echocardiography to improve use of the implanted device called “cardiac resynchronization therapy” in patients with heart failure.

You are being asked to take part in this study because you have been diagnosed with heart failure (HF) a chronic condition associated with heart muscle weakness and do not have heart arrythmia abnormality called left bundle branch block (LBBB), and you are scheduled to undergo implantation of a cardiac resynchronization therapy device with a defibrillator (CRT-D).

Please reach out to Sherry Pellegrino at 412-647-8437 for additional information.

INTEGRA-D

PI: Sandeep Jain, MD
Research Coordinator: Eric Pasquantonio

The OPTIMIZER INTEGRA CCM-D System, also known as a “Cardiac Contractility Modulation – Defibrillator” is an investigational device system that combines CCM® therapy and ICD therapy into one device. “Investigational” means that the study device is currently being tested.  It is not approved by the U.S. Food and Drug Administration (FDA). 

You may be eligible if your doctor has determined that CCM® therapy could effectively treat your heart failure and an ICD device could save your life as you are at risk for sudden cardiac arrest. This research study is designed to determine if the combination of CCM® and ICD, as an investigational device (OPTIMIZER INTEGRA CCM-D System) can effectively defibrillate and treat episodes of VT/VF should any occur.  

Please reach out to Eric Pasquantonio, RN, for details 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.

Optimizer PAS

PI: Sandeep Jain, MD
Research Coordinator: Susan Sweeny

Do you have Heart Failure? You may be interested in the FDA approved Optimizer Smart, which is a device used to treat heart failure in patients on medical therapy who still have significant symptoms. Optimizer Smart devices are implanted just the way pacemakers/defibrillators are implanted, through a small incision. Participants will be asked to complete the following:

• Study Related testing at no cost to determine eligibility
• 1 clinic visit after implant of the Optimizer Smart System
• Routine checks via phone calls
• One annual in-home visit for 3 years

Ask your doctor about the Optimizer Smart CCM device, and about participating in the Optimizer Smart Post Approval study.

Contact Susan Sweeny, RN, at 412-864-1420 or sweenysm@upmc.edu.

We're also offering this study at UPMC in Harrisburg.

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.   

PSR

PI: Sandeep Jain, MD
Research Coordinator: Susan Sweeny

Looking for patients who received Medtronic’s 3830 HIS Bundle Lead (Medtronic product).

Reach out to Susan, RN, at 412-864-1420 or sweenysm@upmc.edu, or Eric, RN, at 412-647-8210 or pasquantonioej@upmc.edu

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

AIM HIGHer

PI: Brittany Palmer, MD

Research Coordinator: Traci McGaha

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).

ARCHER

PI: Brittany Palmer, MD

Research Coordinator: Kristin Shoemaker, RN

The study will evaluate the impact of Cardiol (new formulation of cannabidiol (CBD) oil) of myocardial recovery in patient with acute myocarditis.

Please contact Kristin Shoemaker 412-692-2769 (shoeka@upmc.edu) or Brittany Palmer (palmerba2@upmc.edu). 

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).

MED TRACE 

PI: Prem Soman, MD

Research Coordinator: Chrissee 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 follow up 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.   

Please reach out to Chrissee Smith (study coordinator) smithcm37@upmc.edu  or Prem Soman (PI) at somanp@upmc.edu.

OCCLUFLEX

PI: Conrad Smith, MD

Research Coordinator: Kelly Kuniak

Randomized clinical investigation comparing PFO outcomes of the Occlutech Flex II PFO Occluder to standard of care PFO occlusion. Looking for patients 18 years of age or older who have had a cryptogenic stroke due to a presumed paradoxical embolism as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke, and a PFO determined by echocardiography. 

Please reach out to Kelly Kuniak (study coordinator) kuniakkc@upmc.edu or Dr Conrad Smith (PI) smithaj@upmc.edu.

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.   

OCCLUFLEX

PI: Conrad Smith, MD
Research Coordinator: Chrisse Smith

Randomized clinical investigation comparing PFO outcomes of the Occlutech Flex II PFO Occluder to standard of care PFO occlusion. Looking for patients 18 years of age or older who have had a cryptogenic stroke due to a presumed paradoxical embolism as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke, and a PFO determined by echocardiography.

Please reach out to Chrissee Smith at smithcm37@upmc.edu or Dr Conrad Smith (PI) at smithaj@upmc.edu.

A ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection: PERSEVERE

PI: Ibrahim Sultan, MD
Research Coordinator: Kristin Konopka
The purpose of this research study is to find out if AMDS is safe and effective in the treatment of acute dissection (sudden tear).

ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve through Implantation of ACURATE in Subjects InDicatEd for TAVR

PI:  Ibrahim Sultan, MD
Research Coordinator: Stephanie Trbovich

The purpose of this study is to evaluate safety and effectiveness of the Boston Scientific ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.  

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial (LeAAPS)

PI: Ibrahim Sultan, MD
Research Coordinator: Stephanie Trbovich

This is an Investigational Device Exemption (IDE) randomized clinical research trial (referred to also as a trial or a research trial) sponsored by AtriCure, Inc. (the Sponsor) to learn whether the use of the AtriClip® LAA Exclusion System to close off your left atrial appendage (LAA) during your heart surgery will reduce the risk of stroke.

The purpose of the trial is to test if closing off the LAA with a surgical device known as the AtriClip® reduces stroke occurrence in patients like yourself, who do not have AF but who have one or more risk factors for developing AF in the next 5 years.

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: Melissa Sanders Linger

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.

The PROGRESS Trial - A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement

PI: Ibrahim Sultan, MD
Research Coordinator: Kristin Konopka

This study is being done to see if the SAPIEN 3™ and SAPIEN 3 Ultra™ Transcatheter Heart Valve is beneficial for patients with moderate, calcific aortic stenosis. You will be randomly assigned to one of two groups. You will have an equal chance of getting into either group (like flipping a coin):

1. Treatment Group: If you are assigned to this group, you will have a procedure to replace your aortic valve with the Edwards SAPIEN 3 or Edwards SAPIEN 3 Ultra system. The type of procedure for this device is called Transcatheter Aortic Valve Replacement (TAVR).
2. Clinical Surveillance Group: If you are assigned to this group, you will not have your heart valve replaced. However, your doctor will continue to provide optimal medical therapy and will closely monitor how you are doing (this is called ‘Clinical Surveillance’).

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.

WiSPR: Study to Assess WiSPR (Wireless Sensing, Processing, and Recording reusable patch in Transcatheter Aortic Valve Replacement (TAVR) patients

PI: Ibrahim Sultan, MD
Research Coordinator: Gail Wallen

The study will test the use of an adhesive patch that can measure your vital signs . The measurements collected by the WiSPR patch will be compared to standard vital signs collected during the operating room surgery if in the surgery cohort.  The Home Assessment Cohort will be sent home with the patch to wear for 7 days to track a patients vital signs.

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.

GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

PI: Michael Singh, MD
Research Coordinators: Judith Brimmeier, 412-623-8486 | Julianna Sheline, 412-235-1304

A study of patients with aortic aneurysm involving the visceral vessels requiring treatment defined as:

• Fusiform aneurysm diameter ≥ 5cm.
• Saccular aneurysm.
• Rapid aneurysm growth.

Must also have proper aortic anatomy to receive the TAMBE device.

This prospective, non-randomized, multi-center study has two independent arms:

• TAAA requiring only TAMBE system.
• TAAA requiring TAMBE system and CTAG device(s).

The study is to assess the safety and effectiveness of the TAMBE device in treating thoracoabdominal and pararenal aortic aneurysms.

BEST-Registry

PI: Rabih Chaer, MD
Research Coordinators: Julianna Sheline, 412-235-1304 | Judith Brimmeier, 412-623-8486
A study of patients who have infrainguinal peripheral artery disease with critical limb ischemia consistent with Rutherford categories 4-6.

These include:

• Arterial insufficiency with gangrene.
• Non-healing ischemic ulcer.
• Rest pain.

This prospective, multi-center registry of people with critical limb ischemia will study:

• Real-world treatment strategies.
• Clinical outcomes.
• Health care costs.

The RESCUE Study

PI: Rabih Chaer, MD
Research Coordinators: Judith Brimmeier, 412-623-8486 | Julianna Sheline, 412-235-1304
A study of people with:

• PE symptom duration ≤ 14 days.
• Filling defect in at least one main or lobar pulmonary artery as determined by CTA.
• RV/LV diameter ratio ≥ 0.9 by CTAA.

This prospective, non-randomized, multi-center trial will study the efficacy of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism.

Chronic Venous Thrombosis Relief with Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)

PI: Eric Hager, MD
Research Coordinators: Julianna Sheline, 412-235-1304 | Judith Brimmeier, 412-623-8486
This study focuses on disabling (moderate-to-severe) PTS with:

• VCSS ≥ 8 or Villalta ≥ 10.
• Or open ulcer and iliac vein obstruction (occlusion or > 50% area stenosis).

This is a randomized, multi-center, assessor-blind trial to learn if imaging-guided endovascular therapy (EVT) is an effective strategy to reduce PTS disease severity and improve QOL in patients with established DIO-PTS (disabling iliac occlusion-post thrombotic syndrome).

VIVID Trial

PI: Rabih Chaer, MD
Research Coordinators: Judith Brimmeier, 412-623-8486 | Julianna Sheline, 412-235-1304
A study of patients with nonmalignant iliofemoral venous outflow obstruction presenting with:

• Non-thrombotic disease.
• Acute thrombotic disease.
• Chronic post-thrombotic disease.

The prospective, single-arm, non-blinded, multi-center clinical trial will study the safety and efficacy of the Vesper DUO Venous Stent System in treating people with iliofemoral occlusive disease.

GORE® TAG® Thoracic Branch Endoprosthesis

PI: Michael Singh, MD
Research Coordinators: Judith Brimmeier, 412-623-8486 | Julianna Sheline, 412-235-1304
A study of patients > 18 years of age with thoracic aortic lesions which require coverage of the left subclavian artery, left common carotid artery and/or the brachiocephalic trunk/innominate artery for effective treatment and have anatomy suitable for treatment with the TAG TBE device. The prospective, non-randomized study will assess the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) treating lesions of the aortic arch and the descending thoracic aorta.

GORE® EXCLUDER® Conformable AAA Endoprosthesis

PI: Georges Al-Khoury, MD
Research Coordinators: Judith Brimmeier, 412-623-8486 | Julianna Sheline, 412-235-1304
A study of patients > 21 years of age with a AAA that meet any of the following criteria:

• Maximum diameter ≥ 50 mm.
• Rapid growth (> 5 mm in a six-month period).
• Non-ruptured AAA presenting with clinical symptoms.

All must have the anatomy suitable for treatment with the CEXC device.

This prospective, non-randomized study will assess the safety and effectiveness of the CEXC device for treating infrarenal AAA. The CEXC device will allow endovascular treatment in hostile infrarenal aortic anatomy characterized by either a short proximal seal zone and/or excessive proximal neck angulation.

The RIGEL Study

PI: Theodore Yuo, MD
Research Coordinators: Julianna Sheline, 412-235-1304 | Judith Brimmeier, 412-623-8486
Pilot of randomized trial of fistula versus graft in elderly patients. This will study patients on hemodialysis through a tunneled dialysis catheter and, in the surgeon's opinion, both a fistula and a graft can be reasonably attempted based on the patient's anatomy.

WAVE Trial

PI: Theodore Yuo, MD
Research Coordinators: Judith Brimmeier, 412-623-8486 | Julianna Sheline, 412-235-1304
A study of patients with an AVG or AVF who have stenosis or occlusion. This prospective, randomized, controlled multi-center clinical trial will compare the Merit WRAPSODY Endovascular Stent Graft to percutaneous transluminal angioplasty for the treatment of venous outflow circus stenosis or occlusion in hemodialysis patients.

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.