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 statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeart Rhythm Clinical and Research Solutions, LLC

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ablation Procedure

Treatment groups

No treatment groups listed

Sponsors and collaborators