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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.
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the 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.
What is being tested
- Ablation Procedure (device)
Sponsor: Heart Rhythm Clinical and Research Solutions, LLC · Participants: 250 · Started: Feb 27, 2024
Contact the study team
- Jennifer Moss · Phone: 615-448-5770
Official record on ClinicalTrials.gov — NCT06324201
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.