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 · NCT06324201 · Observational (researchers observe without assigning treatment) · Lead sponsor: Heart Rhythm Clinical and Research Solutions, LLC
View the official record on ClinicalTrials.gov →Interventions studied
Ablation Procedure
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
21 locations listed across 13 US states.
- 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