# Evolut Low Risk trial

Study · id `cardio:evolut-low-risk` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public)

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

Browse, organ or system: Heart  
Browse, condition area: Valve and congenital heart disease  

## In plain language

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 applicant for the valve's US approval, and the registry lists no masking.

## 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.

## Key facts

- 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: 2223 participants (enrolled count; Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients, snapshot `cardio:ctgov-nct02701283-2026-10-14`, retrieved 2026-10-14); 1468 patients (randomized count; Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients, snapshot `cardio:pubmed-30883053-2026-10-14`, retrieved 2026-10-14)
- Started: 2016-03 (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients, snapshot `cardio:ctgov-nct02701283-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2021-04 (actual) (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients, snapshot `cardio:ctgov-nct02701283-2026-10-14`, retrieved 2026-10-14)
- Completion: 2029-06 (anticipated) (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients, snapshot `cardio:ctgov-nct02701283-2026-10-14`, retrieved 2026-10-14)
- Results first posted: 2021-09-09 (actual) (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients, snapshot `cardio:ctgov-nct02701283-2026-10-14`, retrieved 2026-10-14)
- Countries: United States; Australia; Canada; France; Japan; Netherlands; New Zealand (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients, snapshot `cardio:ctgov-nct02701283-2026-10-14`, retrieved 2026-10-14)
- Care setting: Not reported
- Registry status: "ACTIVE\_NOT\_RECRUITING" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct02701283-2026-10-14`, retrieved 2026-10-14)

## Connected pages

- Registry intervention: Medtronic transcatheter aortic valve replacement systems: CoreValve and Evolut transcatheter valves (`cardio:corevalve-evolut`)
- Registry comparison: SAVR: Surgical aortic valve replacement (`cardio:surgical-aortic-valve-replacement`)
- Registry condition: aortic valve stenosis: Aortic stenosis (`cardio:aortic-stenosis`)
- Lead sponsor on the registry record: Medtronic (`cardio:medtronic`)
- Funder named in the abstract: Medtronic (`cardio:medtronic`)
- Tests transcatheter aortic valve replacement: Transcatheter aortic valve replacement (TAVR) (`cardio:tavr`)

## Provenance

Content hash: 284c281c70e64df747acb69cab738c4a35ea9c1e29d3a1ca1a715291749cc459
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-14