Structural Heart Clinical Trials

GORE REDUCE GSO-PAS 18-01

GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale fPFO): the REDUCE Post Approval Study.

This is a post market approval study for prevention of additional stroke. Every subject has device implanted post Cryptogenic Stroke to close PFO. Device is approved and paid for by both insurance and Medicare. Standard of Care currently followed for patients. This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.

Principal Investigator: Michael Cinquegrani, MD
Primary Sub-Investigator: David S. Marks, MD, MBA
Primary Study Coordinator: Beth Jeanes, CRC II

Status: Currently enrolling
Sub-Category: Structural Heart
ClinicalTrials.gov Identifier: NCT03821129

Meet Our Team

Michael P. Cinquegrani, MD, FACC, FSCAI

Director, Professor

David S. Marks, MD, MBA

Professor of Medicine and Radiology, Vice Chair for Clinical Affairs, Froedtert Hospital Senior Medical Director - Inpatient

CATALYST Trial

Clinical trial of 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 at increased risk for cardioembolic events.

Principal Investigator: James Oujiri, MD
Primary Sub-Investigator: Joshua Meskin, MD
Primary Study Coordinator: Beth Jeanes, CRCII

Status: Currently enrolling
Sub-Category: Structural Heart
ClinicalTrials.gov Identifier: NCT04226547

Meet Our Team

James Oujiri, MD

Associate Professor

Joshua A. Meskin, MD, FACC

Associate Professor; Vice Chair for Ambulatory Operations

RELIEF-Migraine

GSO 17-03 GORE® CARDIOFORM Septal Occluder Migraine Clinical Study (RELIEF Clinical Study): A Study to evaluate the safety and efficacy of transcatheter closure of patent foramen ovale (PFO) for relief of migraine headaches using the GORE CARDIOFORM Septal Occluder.

Principal Investigator: Michael Cinquegrani, MD
Primary Sub-Investigator: James Murtha, MD
Primary Study Coordinator: Shelley Schultz, CRCIII

Status: Currently enrolling
Sub-Category: Structural Heart
ClinicalTrials.gov Identifier: NCT04100135

Meet Our Team

Michael P. Cinquegrani, MD, FACC, FSCAI

Director, Professor

James K. Murtha, MD

Assistant Professor

Specialty: Headache

Cardiovascular Clinical Trials

The Cardiovascular Research Service is currently conducting drug and/or device trials in the cardiac subspecialties listed. However, this does not limit what we may be working on tomorrow.

Please contact the Cardiovascular Trials program by calling (414) 955-6784 or at DOMCVClinTriStaff@mcw.edu.