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Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

NCT03242642 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1056

Last updated 2026-05-19

No results posted yet for this study

Summary

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

Conditions

  • Mitral Valve Regurgitation

Interventions

DEVICE

Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

mitral valve replacement

DEVICE

Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Principal Investigators

  • Michael Mack, MD · Baylor Scott & White Hospital

  • David Adams, MD · Icahn School of Medicine at Mount Sinai

  • Martin Leon, MD · New York Presbyterian Hospital/Columbia University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-23
Primary Completion
2027-05-30
Completion
2036-09-30
FDA Device
Yes

Countries

  • United States
  • Canada
  • Denmark

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 NCT03242642 on ClinicalTrials.gov