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