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
Heart Rhythm Clinical and Research Solutions, LLC
250 participants
Feb 27, 2024
OBSERVATIONAL
Conditions
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 Criteria4
- Symptomatic drug refractory paroxysmal (AF episode terminate spontaneously within 7 days) who, in the opinion of the investigator, are candidates for ablation for AF
- 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
Exclusion Criteria4
- 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
Interventions
Ablation Procedure for paroxysmal atrial fibrillation
Locations(21)
View Full Details on ClinicalTrials.gov
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NCT06324201