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.
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Primary Efficacy Endpoint: Bi-directional block confirmation
Timeframe: Time of procedure, following delivery of last ablation energy delivery point
Primary Safety Endpoint: Composite of serious cardiovascular adverse events
Timeframe: 7-days post procedure