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Medtronic Terminate AF Study
Sponsor: Medtronic Cardiac Surgery
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).
Official title: Irrigated Radio Frequency Ablation to Terminate Non-Paroxysmal Atrial Fibrillation (Terminate AF Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2018-11-15
Completion Date
2026-12
Last Updated
2026-03-05
Healthy Volunteers
No
Interventions
Surgical Ablation
In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed.
Cardioblate and Cryoflex hand held devices
The Cardioblate hand held devices consist of the Cardioblate iRF and Cryo surgical ablation devices.
Locations (15)
Stanford Hospitals and Clinic
Palo Alto, California, United States
Adventist Health St. Helena
St. Helena, California, United States
Hartford Healthcare
Hartford, Connecticut, United States
St Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Corewell Health
Grand Rapids, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
ProMedica Toledo
Toledo, Ohio, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Intermountain Medical Center
Murray, Utah, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Mason Heart Institute
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
St. Joseph Medical Center
Tacoma, Washington, United States