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Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

NCT02701283 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2223

Last updated 2026-05-07

Study results available
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Summary

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Medtronic Transcatheter Aortic Valve Replacement Systems

Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with Medtronic TAVR Systems

DEVICE

Surgical Aortic Valve Replacement (SAVR)

Treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR with a commercially approved surgical bioprothesis

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Michael Reardon, MD · The Methodist Hospital Research Institute

  • John K. Forrest, MD · Yale New Haven Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2021-04-30
Completion
2029-06-30
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Japan
  • Netherlands
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02701283 on ClinicalTrials.gov