Imricor Medical Systems, Inc. announced that the Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter (VISABL-AFL) IDE clinical trial, commenced with two procedures performed at the Cardiovascular Institute of South Paris (ICPS). The VISABL-AFL (NCT05904548) 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.

The sample size is 91 patients, with an interim analysis after 76 patients have achieved the 7-day follow-up. The study includes four hospitals in the U.S. and Europe. Included in the VISABL-AFL trial is Imricor?s proprietary NorthStar Mapping System.

NorthStar allows the user to control the MRI scanner, receive MR images in real-time from the scanner, display those MR images in 3D, actively track Imricor trackable devices, and create 3D electroanatomical maps that include intracardiac electrogram signals from Imricor?s Advantage-MR system.