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Evolut Low Risk trial

A trial that compared TAVR (with a self-expanding Medtronic valve) against open-heart surgery in 1468 people with severe aortic stenosis who were at low risk from surgery. After two years, the rate of death or disabling stroke with TAVR was no worse than with surgery. TAVR had more pacemakers and more aortic regurgitation at 30 days. It was paid for by Medtronic, the FDA applicant for the valve, and the registry lists no masking.

Also called Evolut Low Risk · Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

  • Study
  • In this atlas

Overview

Design
Randomized, parallel-group, open-label noninferiority trial of TAVR with a self-expanding supraannular valve versus surgical aortic valve replacement. The registry records allocation as randomized, intervention model as parallel and masking as none.
Phase
Not applicable
Enrolled
  • 2,223 participants (enrolled count) (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients, retrieved )
  • 1,468 patients (randomized count) (Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients, retrieved )
Sponsor
  • Medtronic Lead sponsor on the registry record
Funder
Registry
  • NCT NCT02701283
Started
(Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients, retrieved )
Primary completion
(actual) (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients, retrieved )
Completion
(anticipated) (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients, retrieved )
Results first posted
(actual) (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients, retrieved )
Countries
United States, Australia, Canada, France, Japan, Netherlands, New Zealand (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients, retrieved )
Care setting
Not reported
Registry status
  • “ACTIVE_NOT_RECRUITING” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Registry NCT02701283 (Medtronic Cardiovascular lead sponsor, class industry, status active but not recruiting, estimated completion 2029-06). Randomized, parallel, no masking, treatment. Abstract: Bayesian analysis of the 24-month death or disabling stroke end point when 850 patients had reached 12-month follow-up; 5.3% versus 6.7%. The registry also covers a continued access study, which is why its count (2223) is larger than the 1468 randomized in the paper. The start date has no type in the registry. Findings are not tabulated because the primary composite has no outcome record in this atlas.

Arms

  • TAVR with a Medtronic self-expanding valve

    Intervention CoreValve and Evolut transcatheter valves

    Treatment with the Medtronic CoreValve System or the Medtronic CoreValve Evolut R System (registry); a self-expanding supraannular bioprosthesis (abstract).

  • Surgical aortic valve replacement

    Intervention Surgical aortic valve replacement

    Commercial surgical aortic valve replacement with a commercially approved surgical bioprosthesis (registry).

Findings

No findings are published for this study.

Record details

Record id
cardio:evolut-low-risk
Content hash
eabfed139b97d6a1d2967c47626bdb9cdcb9a33087d9037feffbc89eb175cb25