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.
Sponsored by Heart Rhythm Clinical and Research Solutions, LLC
About this study
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.
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
Where this study is enrolling
- I'm interested
University of Pennsylvania (UPENN)
Philadelphia, Pennsylvania
Who can participate
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, or any trial that dictates the treatment plan
- ✕3. Persistent or long-standing persistent AF
- ✕4. In the opinion of the investigator, any known contraindication to an ablation procedure
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Trial data sourced from ClinicalTrials.gov.