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Medtronic CoreValve Evolut R U.S. Clinical Study

NCT02207569 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2022-11-02

Study results available
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Summary

The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis are considered at high or extreme risk for surgical aortic valve replacement.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

CoreValve Evolut R TAVR system

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Mathew R Williams, MD · New York Langone Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-08-31
Completion
2020-10-28

Countries

  • United States

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 NCT02207569 on ClinicalTrials.gov