Atrial Flutter Ablation in the iCMR

Recruiting now · Not applicable

Conditions studied: Atrial Flutter Typical

In brief

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.

Key facts

Study ID

NCT05904548

Run by

Imricor Medical Systems

People needed

91

Starts

2024-06-20

Expected to finish

2026-12-31

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Johns Hopkins University (JHU) — Baltimore, Maryland, United States (enrolling)
• l'institut Cardiologique Paris Sud (ICPS) — Massy, France (enrolling)
• Amsterdam University Medical Center (AUMC) — Amsterdam, Netherlands (enrolling)
• University Hospital of Vaud (CHUV) — Lausanne, Switzerland (enrolling)
• University of Virginia (UVA) — Charlottesville, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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