NCT05904548 · Imricor Medical Systems
Atrial Flutter Ablation in the iCMR
(VISABL-AFL)
What this study is about
The VISABL-AFL clinical investigation is a forward-looking, single-treatment group$1, multi-center, interventional, experimental Device Exemption (IDE) trial. The primary objectives of VISABL-AFL are to assess the safety and effectiveness of radiofrequency (RF) ablation of type-I atrial flutter performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 (730 days) per physician opinion
Where
- Baltimore, Maryland
- Charlottesville, Virginia
- Richmond, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations