Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter
Imricor Medical Systems
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 cer…
Interventions
- DeviceRF Ablation
RF ablation for type I atrial flutter under iCMR guidance
Locations (6)
- Johns Hopkins University (JHU)Baltimore, Maryland
- University of Virginia (UVA)Charlottesville, Virginia
- Virginia Commonwealth UniversityRichmond, Virginia
- l'institut Cardiologique Paris Sud (ICPS)Massy
- Amsterdam University Medical Center (AUMC)Amsterdam
- University Hospital of Vaud (CHUV)Lausanne