Medtronic Terminate AF Study
Start Date
11/15/2018
Completion Date
12/1/2026
Summary
The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).
Detailed Description
This is a multi-center, single-arm, prospective, non-randomized, interventional study. A maximum of 160 subjects will be treated at up to 25 centers in the United States (US). The study will include male and female patients with a history of non-paroxysmal atrial fibrillation who are undergoing concomitant cardiac surgery. Subjects will be followed and assessed after procedure and for 12 months. The purpose of this study is to evaluate the safety and effectiveness of the Cardioblate Surgical Ablation iRF and CryoFlex hand held devices to support an indication expansion to include treatment of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) to the product labeling.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Surgical Ablation
Cardioblate and Cryoflex hand held devices
Conditions
Locations
Stanford Hospitals and Clinic
Palo Alto, California 94304
United States
Adventist Health St. Helena
St. Helena, California 94574
United States
Hartford Healthcare
Hartford, Connecticut 06102
United States
St Vincent Heart Center of Indiana
Indianapolis, Indiana 46290
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Corewell Health
Grand Rapids, Michigan 49503
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
ProMedica Toledo
Toledo, Ohio 43606
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United States
Lankenau Medical Center
Wynnewood, Pennsylvania 19096
United States
Intermountain Medical Center
Murray, Utah 84107
United States
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United States
Virginia Mason Heart Institute
Seattle, Washington 98101
United States
Swedish Medical Center
Seattle, Washington 98122
United States
St. Joseph Medical Center
Tacoma, Washington 98405
United States