Atrial Flutter Ablation in the iCMR (NCT05904548) | Clinical Trial Compass
RecruitingNot Applicable
Atrial Flutter Ablation in the iCMR
United States, France, Netherlands91 participantsStarted 2024-06-20
Plain-language summary
The VISABL-AFL clinical investigation is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial. The primary objectives of VISABL-AFL are to assess the safety and efficacy of radiofrequency (RF) ablation of type-I atrial flutter performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.
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:
* Patient indicated for type I atrial flutter ablations with at least 1 documented episode of type I atrial flutter within 6 months (180 days) of enrollment
* Patient 18 years and older
Exclusion Criteria:
* Contraindications for MRI procedures
* Patients who cannot have anti-arrhythmic drugs (class I or class III) prescribed for the treatment of type I atrial flutter stopped on the day of the procedure
* Previous CTI ablation procedures
* Myocardial infarction within 60 days of enrollment
* Current unstable angina
* Cardiac surgery within 90 days of enrollment
* Any cerebral ischemic event (including transient ischemic attacks) within 6 months (180 days) of enrollment
* Thrombocytosis or thrombocytopenia
* Contraindication to anticoagulation therapy
* Currently documented intracardiac thrombus or myxoma
* Implantation of permanent leads of an implantable device in or through the right atrium within 90 days of enrollment
* Prosthetic valve through which the catheter must pass
* Interatrial baffle or patch through which the catheter must pass
* Moderate or severe tricuspid valve regurgitation or stenosis
* Uncompensated congestive heart failure
* Active systemic infection
* Pregnancy or if subject plans to become pregnant during the trial
* Uncontrolled hyperthyroidism
* Any other significant uncontrolled or unstable medical condition
* Enrollment in any concurrent study without Imricor written approval
* Life expectancy of less than or equal to 2 years …
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.