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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 250
- Locations
- 21
- Primary Endpoint
- Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months.
Study Overview
Brief 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.
Detailed 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, may be enrolled into the sub-study if the patient meets eligibility criteria and provides consent for additional follow-up of 24 and 36-months
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months.
Time Frame: 36 months
Freedom from atrial arrhythmia recurrence at 36 months post procedure.
Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 12-months.
Time Frame: 12 months
Freedom from atrial arrhythmia recurrence at 12 months post procedure.
Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months.
Time Frame: 24 months
Freedom from atrial arrhythmia recurrence at 24 months post procedure.
Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module
Time Frame: Day 0-7 post ablation
Adverse events from post-procedure through 7-day post ablation visit.
Secondary Outcomes
No secondary outcomes reported