Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New heart valve procedure offers hope for High-Risk patients

NCT ID NCT02322840

Disease control Sponsor: Medtronic Cardiovascular Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device called the Intrepid Transcatheter Mitral Valve Replacement System for people with severe mitral regurgitation (a leaky heart valve) who are too high-risk for open-heart surgery. The goal is to see if the device is safe and works well. About 128 participants will receive the new valve through a tube inserted in a leg vein.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

128 people

The number who actually took part.

Started

Apr 2015

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Severe mitral regurgitation (PILOT) * moderate-severe or severe mitral regurgitation (EFS) * Symptomatic mitral regurgitation (NYHA Class II-IV) * Deemed to be at high risk for conventional mitral valve surgery by the local heart team (including, at minimum, a cardiac surgeon, interventional cardiologist, and an echocardiologist) (PILOT and EFS) * Subjects anatomically suitable for the Intrepid TMVR delivery system, including transfemoral and transseptal access (EFS only) * Native mitral valve geometry and size compatible with the Intrepid™ TMVR (PILOT) Key Exclusion Criteria: * Left ventricular ejection fraction (LVEF) \< 20 (PILOT) or \<30% (EFS) * Evidence of intracardiac mass, thrombus, or vegetation * Prior valve surgery or need for other valve surgery * Prior stroke within 30 days (PILOT) or 90 days (EFS) * Gastrointestinal bleeding within 6 months (PILOT) * Prior myocardial infarction 90 days (EFS) * Need for coronary revascularization * History of, or active, endocarditis if antibiotics are required (EFS) * Renal insufficiency; Serum Creatinine \> 2.5 mg/dL (PILOT) or Creatinine Clearance \<30 cc/min (EFS)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Mitral valve insufficiency are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

mitral valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mitral valve insufficiency

Contacts and locations

Locations

  • Abbott Northwestern Hospital - EFS

    Minneapolis, Minnesota, 55407, United States

  • Abbott Northwestern Hospital - PILOT

    Minneapolis, Minnesota, 55407, United States

  • Abrazo Arizona Heart Hospital - EFS

    Phoenix, Arizona, 85016, United States

  • Aurora Saint Luke's Medical Center - EFS

    Milwaukee, Wisconsin, 53215, United States

  • Aurora Saint Lukes Medical Center - PILOT

    Milwaukee, Wisconsin, 53215, United States

  • Barnes Jewish Hospital - PILOT

    St Louis, Missouri, 63110, United States

  • Baylor Jack and Jane Hamilton Heart and Vascular Hospital - PILOT

    Dallas, Texas, 75246, United States

  • Cedars-Sinai Medical Center - PILOT

    Los Angeles, California, 90048, United States

  • Centre Hospitalier Régional Universitaire de Lille - PILOT

    Lille, France

  • Clinique Pasteur - PILOT

    Toulouse, France

  • Corewell Health - EFS

    Grand Rapids, Michigan, 49503, United States

  • Guys & St Thomas NHS Foundation Trust - St Thomas Hospital - PILOT

    London, United Kingdom

  • Helsinki University Hospital - PILOT

    Helsinki, FL-00029 HUS, Finland

  • Houston Methodist Hospital - PILOT

    Houston, Texas, 77030, United States

  • Hygeia Hospital - PILOT

    Athens, Greece

  • Monash Health - PILOT

    Clayton, Victoria, 3168, Australia

  • NYU Langone Medical Center - PILOT

    New York, New York, 10016, United States

  • New York-Presbyterian Hospital Columbia University Medical Center - EFS

    New York, New York, 10032, United States

  • New York-Presbyterian Hospital Columbia University Medical Center - PILOT

    New York, New York, 10032, United States

  • Northwestern Memorial Hospital - PILOT

    Chicago, Illinois, 60208, United States

  • Oregon Health & Science University Hospital - EFS

    Portland, Oregon, 97239, United States

  • Piedmont Atlanta Hospital - PILOT

    Atlanta, Georgia, 30309, United States

  • Rigshospitalet - PILOT

    Copenhagen, Denmark

  • Royal Prince Alfred Hospital - PILOT

    Sydney, Australia

  • Royal Sussex County Hospital - PILOT

    Brighton, United Kingdom

  • The Alfred Hospital - PILOT

    Melbourne, Australia

  • The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary - PILOT

    Leeds, LS1 3EX, United Kingdom

  • The Mount Sinai Hospital (New York NY) - EFS

    New York, New York, 10029, United States

  • The Mount Sinai Hospital (New York NY) - PILOT

    New York, New York, 10029, United States

  • UPMC Pinnacle Harrisburg Campus - EFS

    Wormleysburg, Pennsylvania, 17043, United States

  • University of Michigan Health System - University Hospital - PILOT

    Ann Arbor, Michigan, 48109, United States

  • University of Virginia Medical Center - EFS

    Charlottesville, Virginia, 22908, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.