Heart and Vascular Clinical Trials

AID MI Study

PI: Samir Saba, MD
Research Coordinator: Donna Simpson, RN

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. 

• 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. 
  

Reach out to Donna, RN (UPMC Lead Site Coordinator) at (412) 647-4463 or simpsondm@upmc.edu or Eric, RN at (412) 647-8210 or pasquantonioej@upmc.edu for more details. 

Avier DR i2i Study

PI: Sandeep Jain, MD
Research Coordinator: Liz Benckart

The Aveir™ DR i2i Study will evaluate the Aveir™ Dual-chamber Leadless Pacemaker System in patients who require bradycardia (slow heartbeat) pacing therapy to monitor and manage their heart rate. Participants in the study will play an important role in helping doctors evaluate leadless pacing as an option for people with slow or irregular heart rhythms. You may qualify if:

• You have been diagnosed with symptomatic bradycardia, sinus pauses and/or AV block.
• Your physician has told you that a dual-chamber pacemaker may help your slow or irregular heartbeat.

Reach out to Liz, RN, for details at (412) 647-4463 or by email at benckarte2@upmc.edu. 

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 
• 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

**We're expecting activation soon. Please reach out to Susan Sweeny, RN, for details at 412-864-1420 or sweenysm@upmc.edu.**

Champion AF

PI: Sandeep Jain, MD
Research Coordinator: Liz Benckart

Currently, WATCHMAN is an FDA approved device alternative for AFib patients who are unable to tolerate long-term blood thinner medication. The CHAMPION-AF Clinical trial is studying WATCHMAN as a first choice option versus blood thinners (NOAC) for AFib patients who may be medically able to tolerate long-term blood thinner use, but would consider a one-time option for stroke risk reduction.

You may be a candidate for the CHAMPION-AF clinical trial if you can answer YES to the following questions:

• I have been diagnosed with non-valvular atrial fibrillation 
• I have been deemed suitable for long term-blood thinner therapy
• I would prefer a one-time for a lifetime procedure option that permanently reduces stroke risk

To learn more, contact Liz Benckart at 412-647-4463 or benckarte2@upmc.edu.

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

PI: Chinmay Patel, MD
Research Coordinator: Dawn Macfarlane

FACT CRT

PI: Andrew Voigt, MD
Research Coordinator: Eric Pasquantonio, RN

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).

** We are expecting activation soon. Please reach out to Eric Pasquantonio at 412-647-4463 for additional information.**

Optimizer PAS

PI: Sandeep Jain, MD
Research Coordinator: Sherry Pellegin

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 Sherry Pellegrino at 412-647-8437 or pellegrinosl@upmc.edu to learn more.

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.   

If you have any potential candidates for the study, please contact Susan Sweeny, RN, at 412-864-1420 or sweenysm@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've currently paused enrollment for this study. It should resume shortly.

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

Sync AV

PI: Aditya Bhonsale, MD
Research Coordinator: Sherry Pellegrino
A study of patients to receive a new CRT implant or upgrade (Abbott CRT device and Abbott Quadripolar LV Lead) to an existing ICD/pacemaker implant.

They must not have prior LV lead placement and must have:

• HF
• LVEF ≤ 35%
• LBBB
• Intact AV conduction

The SyncAV post-market trial will study changes in left ventricular end-systolic volume (LVESV) between:

• Baseline (before CRT implant).
• 12 months (post-randomization).

The study will compare patients with CRT devices programmed with SyncAV to those programmed with fixed AV delay.

Contact Sherry Pellegrino at 412-647-8437 or pellegrinosl@upmc.edu.

Cordella™ Pulmonary Artery Sensor System for Class III Heart Failure Patients

PI: Gavin Hickey, MD
Research Coordinator: Rachel McGargle
A study of New York Heart Association (NYHA) Class III heart failure patients. This prospective, multi-center, randomized, controlled, single blind clinical trial will assess the safety and efficacy of the Cordella pulmonary artery sensor system.

CARE-HF and CARE-PH

PI: Brittany Palmer, MD
These trials will observe a real-world cohort of PAH patients newly initiating any PAH drug-therapy with guideline-directed assessments of disease severity.

LUX-DX-TRENDS

PI: Brittany Palmer, MD
Research Coordinator: Kristin Shoemaker, RN

Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study

• Inclusion Criteria: Diagnosis of Heart Failure
• Exclusion Criteria: Currently have a defibrillator 

SUMMIT

PI: Brittany Palmer, MD
Research Coordinator: Abbey Sung, RN

Study is enrolling to evaluate the safety and effectiveness of a study drug compared to placebo in adults ages 40 and older who have heart failure with preserved ejection fraction (HFpEF) and a body mass index (BI) of at least 30kg/m².

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.

AG10-34

PI: Prem Soman, MD
A study of patients with symptomatic transthyretin amyloid cardiomyopathy who completed the phase 3 attribute-cm trial (ag10-301).
This is an open-label extension and safety monitoring study of acoramidis (ag10).

ALIVE: Study of the BioVentrix Revivent TC System for Treatment of Left Ventricular Aneurysms

PI: Catalin Toma, MD
Research Coordinator: Sarah Tomer
The Revivent TC system is for patients suffering from symptomatic heart failure referred for treatment of left ventricular aneurysms.
This prospective, multi-center, dual arm pivotal study with 2:1 active concurrent control group allocation ratio is also available at UPMC in Harrisburg.

PI: Mubashir Mumtaz, MD
Research Coordinator: Courtney Rodgers

ATTR-CM-R6MWT

PI: Prem Soman, MD

A study of patients with transthyretin amyloid cardiomyopathy and heart failure. This study will capture the performance data of a 6-minute walk test by a wearable monitoring device.

TRILUMINATE Pivotal

PI: Conrad Smith, MD
Research Coordinator: Sarah Tomer
Looking for symptomatic patients with severe tricuspid regurgitation.
This prospective, randomized controlled study will assess treatment outcomes of the Triclip™ device.

Guided Physiologic Stenting (DEFINE GPS)

PI: Catalin Toma, MD

This is a study of the functional performance with intravascular sensors to assess the narrowing effect.

FLAME

PI: Catalin Toma, MD
Research Coordinator: Mary Jo Albright
A study of patients diagnosed with high-risk (massive) pulmonary embolism.
The main objective of this observational study is to compare treatment outcomes of the FlowTriever System to an established literature-based performance goal. We'll also study outcomes of patients who have received treatment with other (non-FlowTriever) therapies.

FLARE

PI: Catalin Toma, MD
Research Coordinator: Mary Jo Albright
This will study the safety and effectiveness of the FlowTriever System for removing emboli from the pulmonary arteries in treating acute pulmonary embolism (PE). We'll use a real-world population to study this device that closely matches its use in clinical practice.

Heart Attack Research Program (HARP)

PI: Catalin Toma, MD

Myocardial Ischemia and Transfusion (MINT) Trial

PI: Catalin Toma, MD
Research Coordinator: Mary Jo Albright
This multicenter trial randomly allocates 3,500 patients with acute myocardial infarction and a hemoglobin concentration less than 10 g/dL. They'll receive either a liberal or restrictive blood transfusion treatments strategy.

NUCGENE

PI: Prem Soman, MD
A pilot study to assess:

• The prevalence and determinants of global myocardial flow reserve abnormalities.
• Its association with impaired vasoreactivity and the CYB5R3 T117S gene variant in African American women with chest pain referred for myocardial perfusion imaging.

PK Papyrus Coronary Stent Graft System (PK Papyrus)

PI: Suresh Mulukutla, MD

Radiance: A study of the ReCor Medical Paradise System in Stage II Hypertension

PI: John Pacella, MD
Research Coordinator: Mary Jo Albright
This trial will study the effectiveness and safety of the Paradise renal denervation system in people with stage 2 hypertension.

STEMI DTU

PI: Jeff Fowler, DO
Research Coordinator: Sarah Tomer
Impella™ unloading to lessen heart failure after ST-elevation myocardial infarction (STEMI).

Quikclot

PI: Ibrahim Sultan, MD
Research Coordinator: Kristin Konopka
This will study the safety and effectiveness of a device called QuikClot Control+ Hemostatic Dressing. The device controls mild and moderate bleeding that occurs at the access site into the heart — such as the sternum — or at the suture lines during heart surgery. We're also doing this study at UPMC in Harrisburg. UPMC Harrisburg was the first site in the United States to enroll a patient in this trial.

PI: Mubashir Mumtaz, MD
Research Coordinator: Anita Todd

Proact Aortic On-X

PI: Ibrahim Sultan, MD
Research Coordinator: Kristin Konopka
We are currently recruiting patients implanted with an On-X prosthetic heart valve for a randomized, active (warfarin) controlled trial. The purpose of this study is to learn if apixaban — an anticoagulant drug different from warfarin — is safe and effective for those with an On-X aortic valve. Cryolife, Inc., sponsors the study.

TiGER-001 Study

PI: Ibrahim Sultan, MD
Research Coordinator: Kristin Konopka

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.

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.

TAVR Unload: Transcatheter Aortic Valve Replacement to Unload the Left Ventricle in Patients with Advanced Heart Failure: A Randomized Trial

PI: Ibrahim Sultan, MD
Research Coordinator: Kristin Konopka
An international, multi-center, clinical trial will compare the safety and effectiveness of TAVR with the Edwards SAPIEN 3 or SAPIEN 3 Ultra transcatheter heart valve (THV) and optimal heart failure therapy (OHFT) versus OHFT alone in heart failure patients with moderate aortic stenosis. We're also doing this study at UPMC in Harrisburg.

PI: Hemal Gada, MD
Research Coordinator: Courtney Rodgers

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.