EXPAND II
Research type
Research Study
Full title
Evolut™ EXPAND TAVR II Pivotal Trial. Multi-center, international, prospective, randomized. Subjects will be randomized on 1:1 basis to Transcatheter Aortic Valve Replacement (TAVR) using the Medtronic Evolut PRO+ TAVR system + guideline-directed management and therapy (GDMT) or GDMT alone
IRAS ID
312684
Contact name
Guy Lloyd
Contact email
Sponsor organisation
Medtronic, Bakken Research Center B.V.
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 0 months, 30 days
Research summary
The purpose of this trial is to evaluate the safety and effectiveness of the Medtronic Evolut PRO+ TAVR system and guideline-directed management and therapy (GDMT) compared to GDMT in patients with moderate, symptomatic Aortic Stenosis. Aortic Stenosis is a condition when the opening in your aortic valve is narrowed. Valves affected by stenosis limit blood flow, which cause the heart to have to work harder to squeeze blood through the narrowed valve than it does when the valve opening is normal. The extra work required of the heart to pump blood through the narrowed valve may cause symptoms, such as fatigue, shortness of breath, chest pain, light-headedness, or fainting.
Aortic stenosis is a progressive disease, which means it tends get worse over time. Because of this, doctors will typically measure it as mild, moderate, or severe aortic stenosis. The treatment for aortic stenosis depends on the severity of the narrowing. Replacement of the valve is usually recommended when the stenosis is severe. Replacement of the aortic valve relieves obstruction to blood flow through the heart, improves symptoms, helps the heart work better, and allows patients to live longer. Valve replacement can be done during open-heart surgery or by a less invasive approach, called transcatheter aortic valve replacement, or TAVR.
Replacement of the aortic valve is usually not recommended until the degree of narrowing is measured as severe. However, recent studies have shown that some patients with moderate stenosis may be at similar risk for heart failure or serious heart-related events as patients with severe aortic stenosis. Therefore, the purpose of this study is to determine if it beneficial to replace the narrowed aortic valve before it becomes severely narrowed.REC name
North of Scotland Research Ethics Committee 1
REC reference
22/NS/0068
Date of REC Opinion
27 May 2022
REC opinion
Favourable Opinion