TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
Completed · Not applicable
Conditions studied: Paroxysmal Atrial Fibrillation
In brief
Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated using the full range of ablation power settings in the Instructions For Use. Subjects in the High Standard Power Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).
Key facts
- Study ID
- NCT04356040
- Run by
- Abbott Medical Devices
- People needed
- 355
- Starts
- 2020-06-29
- Expected to finish
- 2022-07-01
- Last updated by the study team
- 2023-10-31
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Affinity Cardiovascular Specialists, LLC — Birmingham, Alabama, United States
- St. Bernards Medical Center — Jonesboro, Arkansas, United States
- Arkansas Heart Hospital — Little Rock, Arkansas, United States
- Mills-Peninsula Medical Center — Burlingame, California, United States
- Scripps Health — La Jolla, California, United States
- University of California at San Diego (UCSD) Medical Center — San Diego, California, United States
- South Denver Cardiology Associates PC — Littleton, Colorado, United States
- AdventHealth Orlando — Orlando, Florida, United States
- Piedmont Athens Regional Medical Center — Athens, Georgia, United States
- St. Luke's Regional Medical Center — Boise, Idaho, United States
- Kootenai Heart Clinics — Coeur d'Alene, Idaho, United States
- St. Vincent Hospital — Indianapolis, Indiana, United States
- Iowa Heart Center — West Des Moines, Iowa, United States
- Kansas City Cardiac Arrhythmia Research Foundation — Overland Park, Kansas, United States
- Ochsner Medical Center — New Orleans, Louisiana, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Providence Hospital — Southfield, Michigan, United States
- Jackson Heart Clinic — Jackson, Mississippi, United States
- North Mississippi Medical Center — Tupelo, Mississippi, United States
- New York University Hospital — New York, New York, United States
- New York-Presbyterian/Columbia University Medical Center — New York, New York, United States
- NC Heart & Vascular Research — Raleigh, North Carolina, United States
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Ohio State University — Columbus, Ohio, United States
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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