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Atrial Flutter Ablation in the iCMR

Sponsor: Imricor Medical Systems • ClinicalTrials.gov ID: NCT05904548

Registry updated: 2026-10-19

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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.

Interventions

RF Ablation (Device)
RF ablation for type I atrial flutter under iCMR guidance

Eligibility criteria

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

Conditions

Atrial Flutter Typical

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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