Medtronic (NYSE:MDT) announced today that it enrolled the first patient in its Expand TAVR II pivotal trial.
Expand TAVR II will evaluate the self-expanding, supra-annular Evolut transcatheter aortic valve replacement (TAVR) platform in patients with moderate, symptomatic aortic stenosis (AS), a population outside of current guidelines and indications for TAVR.
According to a news release, the first patient was enrolled by a team led by Dr. Shigeru Saito and Dr. Tomoki Ochiai at Shonan Kamakura General Hospital in Kamakura, Japan.
The multi-center, international, prospective trial will be conducted in the U.S., Canada, Japan, EMEA regions, Australia and New Zealand, following FDA investigational device exemption approval in October 2021 and clinical trial approval from the Japan Pharmaceutical and Medical Device Agency (PMDA) in February 2022.
Medtronic said the trial will evaluate the safety and effectiveness of the Evolut Pro+ TAVR system and guideline-directed management and therapy (GDMT) compared to GDMT alone in the moderate, symptomatic aortic stenosis patient population.
Expand TAVR II will enroll up to 650 patients at up to 100 sites globally with two co-primary endpoints to evaluate the safety and efficacy of Evolut TAVR with follow-up out to ten years. The primary safety endpoint is a composite of all-cause mortality, all-stroke, life-threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication or valve dysfunction (requiring intervention) at 30 days.
The primary effectiveness endpoint is the composite rate of all-cause mortality, heart failure event, or aortic valve replacement or reintervention at two years, Medtronic said.
“We are thrilled to have the first patient enrolled in this important trial as we assess the performance of the Evolut TAVR platform in new patient populations,” CMO of Medtronic’s Structural Heart and Aortic Business Dr. Jeffery Popma said in the release. “Demonstrating our leadership in structural heart and continued commitment to generating robust clinical evidence, results from this study will support our clinical strategy to pursue a broader indication of the therapy as we work to treat more patients around the world.”