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NCT05904548NARecruiting

Atrial Flutter Ablation in the iCMR

Imricor Medical Systems

Start Date

6/20/2024

Completion Date

12/31/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

RF Ablation

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Conditions

Atrial Flutter Typical

Locations

Johns Hopkins University (JHU)

Baltimore, Maryland 21218

United States

University of Virginia (UVA)

Charlottesville, Virginia 22903

United States

Virginia Commonwealth University

Richmond, Virginia 23284

United States

l'institut Cardiologique Paris Sud (ICPS)

Massy, 91300

France

Amsterdam University Medical Center (AUMC)

Amsterdam,

Netherlands

University Hospital of Vaud (CHUV)

Lausanne, 1011

Switzerland