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.

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.

Eligibility

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

Conditions2

Locations21 sites

Find trials near these locations

Browse More Trials