The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction Wit… (NCT06324201) | Clinical Trial Compass
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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.
United States250 participantsStarted 2024-02-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module
Timeframe: Day 0-7 post ablation
2
Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 12-months.
Timeframe: 12 months
3
Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 24-months.
Timeframe: 24 months
4
Effectiveness of the QDOT Micro System use in conjunction with VISITAG SURPOINT Module at 36-months.
Timeframe: 36 months
Trial details
NCT IDNCT06324201
SponsorHeart Rhythm Clinical and Research Solutions, LLC