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The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.
Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
Summary
Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be screened for enrollment, prospectively or retrospectively, to this sub-study per inclusion and exclusion criteria.
Official title: The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO™ System Use in Conjunction With VISITAG SURPOINT™Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2024-02-27
Completion Date
2028-03
Last Updated
2025-10-31
Healthy Volunteers
No
Conditions
Interventions
Ablation Procedure
Ablation Procedure for paroxysmal atrial fibrillation
Locations (21)
Arrhythmia Institute at Grandview
Birmingham, Alabama, United States
Mobile Cardiology Associates
Mobile, Alabama, United States
Community Memorial Health System
Ventura, California, United States
Medical City - HCA
Aurora, Colorado, United States
Naples Community Hospital
Naples, Florida, United States
Sarasota Memorial Health
Sarasota, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Norton Heart and Vascular Institute
Louisville, Kentucky, United States
The Brigham and Womens Hospital
Boston, Massachusetts, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Trinity Health-Michigan Heart
Ypsilanti, Michigan, United States
The Christ Hospital
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pennsylvania (UPENN)
Philadelphia, Pennsylvania, United States
Allegheny Health
Pittsburgh, Pennsylvania, United States
Centra Health, Inc.dba Stroobants Cardiovascular Center
Lynchburg, Virginia, United States
Bon Secours Medical Group - Richmond Specialty Care
Richmond, Virginia, United States
Valley Health System
Winchester, Virginia, United States
Multicare Health Systems-Pulse Heart
Puyallup, Washington, United States
Franciscan Heart and Vascular Associates
Tacoma, Washington, United States
Mercy Health
Janesville, Wisconsin, United States