NCT06324201 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 ID | NCT06324201 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heart Rhythm Clinical and Research Solutions, LLC |
| Condition | Paroxysmal Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-02-27 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2024-02-27 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Brian Sanchez, MD
STUDY DIRECTOR
J & J Corporation
Frequently Asked Questions
Who can join the NCT06324201 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Paroxysmal Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06324201 currently recruiting?
Yes, NCT06324201 is actively recruiting participants. Contact the research team at jmoss@hrcrs.com for enrollment information.
Where is the NCT06324201 trial being conducted?
This trial is being conducted at Birmingham, United States, Mobile, United States, Ventura, United States, Aurora, United States and 11 additional locations.
Who is sponsoring the NCT06324201 clinical trial?
NCT06324201 is sponsored by Heart Rhythm Clinical and Research Solutions, LLC. The principal investigator is Brian Sanchez, MD at J & J Corporation. The trial plans to enroll 250 participants.
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