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Heart valve registry tracks Real-World device performance

NCT ID NCT04073420

Knowledge-focused Sponsor: Medtronic Cardiac Surgery Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is a registry that will follow up to 2,700 people who have received or will receive a Medtronic heart valve product during surgery. The goal is to monitor the long-term safety and performance of these devices by identifying any unexpected problems or trends. Participants will be asked to provide consent and be available for follow-up visits.

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.

Participants

About 2,700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

Dec 2039

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.

Who is studied

Subjects requiring heart valve therapy replacement and/or repair.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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.

Inclusion Criteria: 1. Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements 2. Patient has or is intended to receive or be treated with an eligible product 3. Patient is within enrollment window of treatment/therapy received at the time of their initial Registry enrollment, or meets criteria for retrospective enrollment Exclusion Criteria: 1. Patient who is, or is expected to be, inaccessible for follow-up 2. Patient prohibited from participation by local law 3. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or device study that may confound results

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Conditions

The condition(s) this trial relates to.

heart valve disorder

As listed by the trial registrant

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

Valve disease, heart

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albertinen-Herz- und Gefäßzentrum

    RECRUITING

    Hamburg, 22457, Germany

  • Allgemeines Krankenhaus - Universitätskliniken Wien

    RECRUITING

    Vienna, 1090, Austria

  • Baylor St. Luke's Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Deutsches Herzzentrum München Klinik an der TU München

    RECRUITING

    München, 80636, Germany

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Herzzentrum Dresden GmbH Universitätsklinik

    RECRUITING

    Dresden, 01307, Germany

  • Herzzentrum Leipzig

    RECRUITING

    Leipzig, Germany

  • Hospital Regional Universitario Carlos Haya Málaga - Hospital General

    RECRUITING

    Málaga, 29010, Spain

  • Hôpital Haut-Lévêque - CHU de Bordeaux

    RECRUITING

    Pessac, 33604, France

  • IRCCS Policlinico

    RECRUITING

    San Donato, Italy

  • Inova

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Inselspital - Universitätsspital Bern

    RECRUITING

    Bern, 3010, Switzerland

  • Leids Universitair Medisch Centrum

    RECRUITING

    Leiden, Netherlands

  • Mount Sinai Medical Center

    RECRUITING

    New York, New York, 10029, United States

  • Onassis Cardiac Surgery Center

    RECRUITING

    Athens, 17674, Greece

  • Ospedale Pasquinucci Massa

    RECRUITING

    Massa, 54100, Italy

  • Saint Francis Hospital

    WITHDRAWN

    Roslyn, New York, 11576, United States

  • Saint Josephs Hospital Health Center

    RECRUITING

    Syracuse, New York, 13203, United States

  • Schüchtermann-Klinik

    RECRUITING

    Bad Rothenfelde, 49214, Germany

  • The Heart Hospital Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • University Hospitals Cleveland

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Center UPMC Presbyterian

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Universitätsklinikum Düsseldorf

    RECRUITING

    Düsseldorf, 40225, Germany

  • WellStar Kennestone Hospital

    RECRUITING

    Marietta, Georgia, 30060, United States

More trials for these conditions

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