Clinical trialNCT02701283Active, not recruitingInterventional

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

SponsorMedtronic CardiovascularEnrollment2,223Aortic Valve Stenosis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

John K. Forrest, MD
Yale New Haven Hospital
Principal Investigator
clinicaltrials.gov ↗
Michael Reardon, MD
The Methodist Hospital Research Institute
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

87 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

Saint Vincent'S Hospital Sydney
Darlinghurst, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
the Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital (fsh)
Murdoch, Western Australia, Australia

Canada

London Health Sciences Centre
London, Ontario, Canada
Toronto General Health Hospital
Toronto, Ontario, Canada
Glen Royal Victoria (mcgill)
Montreal, Quebec, Canada
Iucpq
Québec, Quebec, Canada
Montreal Heart
Montreal, Canada
Sunnybrook Health Sciences Centre
Toronto, Canada

France

Centre Hospitalier Régional Universitaire de Lille
Lille, France
L'Hôpital Privé Jacques Cartier Massy
Massy, France
Clinique Pasteur
Toulouse, France

Japan

Kokura Memorial Hospital
Kitakyushu, Fokuoka, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, Japan
Teikyo University Hospital
Tokyo, Itabashi-Ku, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
National Cerebral and Cardiovasclular Center
Suita, Osaka, Japan
the University of Osaka Hospital
Suita, Osaka, Japan
Sakakibara Heart Institute
Fuchū, Tokyo, Japan

Netherlands

Catharina Ziekenhuis
Eindhoven, Netherlands
St. Antonius Hospital Nieuwegein
Nieuwegein, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands

New Zealand

Waikato Hospital
Hamilton, New Zealand

United States

Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States
Scripps Memorial Hospital la Jolla
La Jolla, California, United States
University of Southern California University Hospital
Los Angeles, California, United States
El Camino Hospital
Mountain View, California, United States
Mercy General Hospital
Sacramento, California, United States
Los Robles Hospital & Medical Center
Thousand Oaks, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Morton Plant Hospital
Clearwater, Florida, United States
Delray Medical Center
Delray Beach, Florida, United States
Healthpark Medical Center
Fort Myers, Florida, United States
University of Miami Hospital
Miami, Florida, United States
Tallahassee Research Institute, Inc.
Tallahassee, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States

47 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Mar 2016
Primary completion: 30 Apr 2021
Completion: 30 Jun 2029
Last update posted: 2 Nov 2026
Registered enrollment: 2,223
Registry id: NCT02701283

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.