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.
Recruiting now
Conditions studied: Paroxysmal Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT06324201
- Run by
- Heart Rhythm Clinical and Research Solutions, LLC
- People needed
- 250
- Starts
- 2024-02-27
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2025-10-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Symptomatic drug refractory paroxysmal (AF episode terminate spontaneously within 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
- 18 years of age or older
- Able and willing to participate in baseline and follow up evaluations for the full length of the sub-study
- Willing and able to provide informed consent for this sub-study
You may not qualify if…
- Patients who have undergone catheter ablation for atrial fibrillation (PVI, roof line, posterior wall ablation...)
- Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
- Persistent or long-standing persistent AF
- In the opinion of the investigator, any known contraindication to an ablation procedure
Where it is running
- Mercy Health — Janesville, Wisconsin, United States (enrolling)
- Mobile Cardiology Associates — Mobile, Alabama, United States (enrolling)
- Community Memorial Health System — Ventura, California, United States (enrolling)
- Medical City - HCA — Aurora, Colorado, United States (enrolling)
- Franciscan Heart and Vascular Associates — Tacoma, Washington, United States (enrolling)
- Arrhythmia Institute at Grandview — Birmingham, Alabama, United States (enrolling)
- Sarasota Memorial Health — Sarasota, Florida, United States (enrolling)
- Piedmont Healthcare — Atlanta, Georgia, United States (enrolling)
- Norton Heart and Vascular Institute — Louisville, Kentucky, United States (enrolling)
- Sparrow Clinical Research Institute — Lansing, Michigan, United States (enrolling)
- Trinity Health-Michigan Heart — Ypsilanti, Michigan, United States (enrolling)
- The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
- University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
- University of Pennsylvania (UPENN) — Philadelphia, Pennsylvania, United States (enrolling)
- Allegheny Health — Pittsburgh, Pennsylvania, United States (enrolling)
- Centra Health, Inc.dba Stroobants Cardiovascular Center — Lynchburg, Virginia, United States (enrolling)
- Bon Secours Medical Group - Richmond Specialty Care — Richmond, Virginia, United States (enrolling)
- Valley Health System — Winchester, Virginia, United States (enrolling)
- Multicare Health Systems-Pulse Heart — Puyallup, Washington, United States (enrolling)
- Naples Community Hospital — Naples, Florida, United States
- The Brigham and Womens Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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