Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Completed · Phase 3
Conditions studied: Atrial Fibrillation
In brief
The primary objective of this clinical investigation is to demonstrate safety and effectiveness of the Multi-Electrode RF Balloon catheter for the treatment of drug refractory symptomatic paroxysmal atrial fibrillation.
Key facts
- Study ID
- NCT03683030
- Run by
- Biosense Webster, Inc.
- People needed
- 397
- Starts
- 2018-10-22
- Expected to finish
- 2022-02-18
- Last updated by the study team
- 2025-10-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Phoenix Cardiovascular Research Group — Phoenix, Arizona, United States
- University of Southern California — Los Angeles, California, United States
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
- Mercy General Hospital — Sacramento, California, United States
- University Of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- Med Center of the Rockies — Loveland, Colorado, United States
- Yale New Haven Hospital — New Haven, Connecticut, United States
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
- Baptist Health Research Institute — Jacksonville, Florida, United States
- AdventHealth Orlando — Orlando, Florida, United States
- Piedmont Hospital — Atlanta, Georgia, United States
- Emory St Joseph's Hospital — Atlanta, Georgia, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Kansas City Arrhythmia Research — Overland Park, Kansas, United States
- The Johns Hopkins Hospital — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Spectrum Health System — Grand Rapids, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
- Morristown Medical Center — Morristown, New Jersey, United States
- The Valley Hospital — Ridgewood, New Jersey, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Lenox Hill Hospital - Northwell Health — New York, New York, United States
- The Ohio State University — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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