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Atrial Flutter Ablation in the iCMR
Recruiting
Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- RF Ablation (device)
Sponsor: Imricor Medical Systems · Participants: 91 · Started: Jun 20, 2024
Contact the study team
- Kate Lindborg · Phone: 952-818-8400
- Jennifer Somerville · Phone: 952-594-4138
Official record on ClinicalTrials.gov — NCT05904548
Locations in the U.S.
| Maryland | Johns Hopkins University (JHU), Baltimore |
| Virginia | University of Virginia (UVA), Charlottesville (Not yet recruiting) Virginia Commonwealth University, Richmond (Not yet recruiting) |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.