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Atrial Flutter Ablation in the iCMR
Sponsor: 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.
Official title: Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
91
Start Date
2024-06-20
Completion Date
2026-12-31
Last Updated
2026-01-27
Healthy Volunteers
No
Conditions
Interventions
RF Ablation
RF ablation for type I atrial flutter under iCMR guidance
Locations (6)
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