The Long-term Safety and Effectiveness Evaluation of the QDOT MICROâ„¢ System Use in Conjunction With VISITAG SURPOINTâ„¢Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
The Long-term Safety and Effectiveness Evaluation of the QDOT MICROâ„¢ System Use in Conjunction With VISITAG SURPOINTâ„¢Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation
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 MICROâ„¢ system (QDOT MICROâ„¢ catheter and nGENâ„¢ generator) in conjunction with VISITAG SURPOINTâ„¢ 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 MICROâ„¢ 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
Inclusion Criteria:
Exclusion Criteria:
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