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
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.
Description
Enrolled QDOT PAS subjects are defined as consented patients with symptomatic paroxysmal atrial fibrillation (PAF) enrolled in the REAL AF registry. These enrolled subjects will be treated with the commercially available QDOT MICRO™ system (QDOT MICRO™ catheter and nGEN™ generator) in conjunction with VISITAG SURPOINT™ Module. Subjects are required to complete scheduled assessments within 12 months of the index procedure, and additional two assessments at 24 and 36-months post procedure. Retrospective consecutive patients from the REAL AF registry, who were ablated with the QDOT MICRO™ system,…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Symptomatic drug refractory paroxysmal (AF episode terminate spontaneously within 7 days) who, in the opinion of the investigator, are candidates for ablation for AF 2. 18 years of age or older 3. Able and willing to participate in baseline and follow up evaluations for the full length of the sub-study 4. Willing and able to provide informed consent for this sub-study Exclusion Criteria: 1. Patients who have undergone catheter ablation for atrial fibrillation (PVI, roof line, posterior wall ablation...) 2. Enrolled in an investigational drug or device clinical trial,…
Interventions
- DeviceAblation Procedure
Ablation Procedure for paroxysmal atrial fibrillation
Locations (21)
- Arrhythmia Institute at GrandviewBirmingham, Alabama
- Mobile Cardiology AssociatesMobile, Alabama
- Community Memorial Health SystemVentura, California
- Medical City - HCAAurora, Colorado
- Naples Community HospitalNaples, Florida
- Sarasota Memorial HealthSarasota, Florida