Paroxysmal Atrial Fibrillation Clinical Trial
— QDOT PASOfficial title:
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
NCT number | NCT06324201 |
Other study ID # | QDOT PAS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 27, 2024 |
Est. completion date | March 2028 |
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 to this sub-study per inclusion and exclusion criteria.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | March 2028 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Mercy Health | Janesville | Wisconsin |
United States | Centra Health, Inc.dba Stroobants Cardiovascular Center | Lynchburg | Virginia |
Lead Sponsor | Collaborator |
---|---|
Heart Rhythm Clinical and Research Solutions, LLC | Biosense Webster, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module | Adverse events from post-procedure through 7-day post ablation visit. | Day 0-7 post ablation | |
Primary | Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 12-months. | Freedom from atrial arrhythmia recurrence at 12 months post procedure. | 12 months | |
Primary | Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months. | Freedom from atrial arrhythmia recurrence at 24 months post procedure. | 24 months | |
Primary | Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months. | Freedom from atrial arrhythmia recurrence at 36 months post procedure. | 36 months |
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