Study ID: SMART
SMall annuli randomized to Evolut™ or SAPIEN™ trial (SMART)
This study will evaluate the safety and performance of a new valve replacement system in patients with aortic stenosis, which is a condition involving the narrowing of the valve opening. To qualify, the patient’s condition must be severe and symptomatic.
The device under evaluation, the Evolut PRO/PRO system, is self-expanding. Its safety and effectiveness will be compared against the currently used SAPIEN 3/3 Ultra System, which expands with a balloon. Patients will undergo a minimally invasive procedure called transcatheter aortic valve replacement to replace their faulty valve and will be assigned on a one-to-one basis to have it performed with either the Evolut or SAPIEN system.
The procedure occurs in a cardiac catherization lab. Data will be collected before and after the procedure, at discharge, at 30 days, and once a year until the five-year follow-up.
Must be deemed symptomatic and a candidate for transcatheter aortic valve replacement (TAVR). Must have predicted risk of operative mortality of less than 15% as determined by the local Heart Team. Must have severe aortic stenosis and a small aortic annulus. Anatomy is suitable for TAVR via transfemoral vessel access.
Intervention/treatment: Multi-center, international, randomized controlled post-market trial to evaluate clinical and hemodynamic effectiveness of the Medtronic Evolut PRO/PRO+ System compared to the Edwards SAPIEN™ 3/3 Ultra System at 12 months post-procedure. Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic self-expanding Transcatheter Aortic Valve or an Edwards balloon-expandable Transcatheter Heart Valve. Data will be collected at pre- and post-procedure, at discharge, at 30 days, and once a year until the five-year follow-up.
- Must be symptomatic and a candidate for transcatheter aortic valve replacement
- Must have severe aortic stenosis and a small aortic annulus
- Must have predicted risk of operative mortality of less than 15%
Additional criteria may apply