Atrial Flutter Ablation in the iCMR
ConditionAtrial Flutter Typical
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorImricor Medical Systems
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- RF Ablation
Treatment groups
91 Participants
are divided into 1 treatment groupLocations
6France
l'institut Cardiologique Paris Sud (ICPS)91300, Massy France
Netherlands
Amsterdam University Medical Center (AUMC) Amsterdam Netherlands
Switzerland
University Hospital of Vaud (CHUV)1011, Lausanne Switzerland
United States
Johns Hopkins University (JHU)21218, BaltimoreMaryland, United States
Sponsors and collaborators
Imricor Medical Systems
Lead sponsor
Source ClinicalTrials.gov