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
Prospective, randomized, controlled, unblinded, multicenter clinical trial of the Amplatzer鈩� Amulet鈩� 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
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
