Medtronic’s EXPAND TAVR II Pivotal Trial Begins Enrollment

May 2, 2022—Medtronic announced the first patient enrollment in the EXPAND TAVR II pivotal trial, which is the first randomized clinical trial evaluating the company’s self-expanding, supra-annular Evolut transcatheter aortic valve replacement (TAVR) platform in patients with moderate symptomatic aortic stenosis (AS).

The company noted that this population of moderate symptomatic AS patients is outside of current guidelines and indications for TAVR. Currently, the recommended management of patients with moderate AS includes periodic monitoring with transthoracic echocardiography every 1 to 2 years (or with any change in symptoms or findings).

The Evolut TAVR platform is approved for patients with severe symptomatic AS worldwide.

According to Medtronic, the EXPAND TAVR II pivotal trial is a multicenter, international, prospective trial to be conducted in the United States; Canada; Japan; Europe, the Middle East, and Africa regions; Australia; and New Zealand. The FDA’s investigational device exemption approval was received in October 2021. In February 2022, clinical trial approval was received from Japan’s Pharmaceutical and Medical Device Agency.

The global trial will evaluate the safety and effectiveness of the Medtronic Evolut Pro+ TAVR system and guideline-directed management and therapy (GDMT) compared to GDMT alone in the moderate symptomatic AS patient population.

The company stated that the EXPAND TAVR II pivotal trial will enroll up to 650 patients at up to 100 sites globally.

The trial will include two coprimary endpoints to evaluate the safety and efficacy of the Evolut TAVR system with follow up out to 10 years:

• The primary safety endpoint is a composite of all-cause mortality, all-stroke, life-threatening or fatal bleeding, acute kidney injury, hospitalization caused by device- or procedure-related complication, or valve dysfunction (requiring reintervention) 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 2 years.

The data from this trial may be used to support future regulatory submissions to expand the current indications for the Evolut TAVR platform, advised the company.

The first patient in the EXPAND TAVR II pivotal trial was enrolled by a team led by Shigeru Saito, MD, and Tomoki Ochiai, MD, at Shonan Kamakura General Hospital in Kamakura, Japan.

The study’s Principal Investigator is Paul Sorajja, MD, Headrick Family Chair, Valve Science Center at the Minneapolis Heart Institute Foundation in Minneapolis, Minnesota.

“There are many patients living with varying levels of aortic stenosis, including moderate symptomatic, who may benefit from the less invasive TAVR procedure even though they fall outside of the current indications,” commented Dr. Sorajja in Medtronic’s press release. “We are excited to add to the growing body of clinical evidence to support the safety and benefits of TAVR in new patient populations.”