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Heart valve repair devices under 5-Year safety spotlight

NCT ID NCT04761120

Disease control Sponsor: Abbott Medical Devices 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 550 people who receive Abbott annuloplasty rings or bands during surgery to fix leaky mitral or tricuspid heart valves. Researchers will track survival, need for repeat surgery, and symptom improvement for five years. The goal is to confirm the devices work well in real-world use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Annuloplasty rings and bands (medical devices implanted during heart valve repair surgery)
What this could lead to
If successful, this study will confirm that these devices are safe and effective for repairing leaky heart valves, helping patients breathe easier and live longer.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. The devices are already on the market, so no new breakthrough is expected.

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 550 people

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

Started

Feb 2021

Expected to finish

Mar 2031

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

This study will enroll male and female adult subjects from the general population of cardiac surgery patients who are expected to be implanted with a Rigid Saddle, Séguin or full Tailor Ring for mitral regurgitation (MR) repair, a full Tailor Ring for tricuspid regurgitation (TR) repair or a Tailor Band or partial Tailor Ring for primary TR repair within 90 days.

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.

Inclusion Criteria: 1. Subject is expected to undergo cardiac surgery in ≤90 days including at least one of the following: 1. implant of a Rigid Saddle Ring, Séguin Ring or a full Tailor Ring without cut zone removal for MR repair 2. implant of a full Tailor Ring without cut zone removal for TR repair, or 3. implant of a Tailor Band or partial Tailor Ring with cut zone removed for primary TR repair. 2. Subject's cardiac surgery will be performed by a study investigator. 3. Subject will be ≥18 years old at the time of their annuloplasty implant(s). 4. Subject provides written informed consent and agrees to comply with all required study visits and procedures. Exclusion Criteria: 1. Subject is below the age of legal consent in the applicable jurisdiction or otherwise lacks legal authority to provide informed consent. 2. Subject is unable to read or write or has a mental illness or disability that impairs their ability to provide written informed consent. 3. Subject is expected to have active endocarditis at the time of their Abbott annuloplasty device implant(s). 4. Subject cannot be unambiguously assigned to a treatment group due to missing data on repair indication(s) or the model and configuration (cut zone removed or not) of their Abbott annuloplasty implant(s). 5. Subject is participating in another clinical investigation including any treatment outside the investigative site's usual standard of care. 6. Subject has anomalous anatomy or medical, surgical, psychiatric or social history or conditions that, in the investigator's opinion, would limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements

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Conditions

The condition(s) this trial relates to.

heart valve disorder mitral valve insufficiency tricuspid valve insufficiency

As listed by the trial registrant

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

Mitral regurgitation Tricuspid regurgitation Valvular heart disease

How to take part

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

  1. The places running it

    13 sites in 6 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

  • CHU de Besançon - Jean Minjoz

    RECRUITING

    Besançon, Bourgogne-Franche-Comté, 25000, France

  • Catharina Ziekenhuis

    RECRUITING

    Eindhoven, North Brabant, 5623 EJ, Netherlands

  • Duke University Hospital

    WITHDRAWN

    Durham, North Carolina, 27710, United States

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, Lombard, 20157, Italy

  • Herzchirurgische Abteilung Klinikum Passau

    RECRUITING

    Passau, Bavaria, 94032, Germany

  • Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • Herzzentrum-Bremen Klinikum Links der Weser

    RECRUITING

    Bremen, Free Hanseatic City of Bremen, 28211, Germany

  • Hopital Cardiovasculaire et Pneumologique Louis Pradel

    RECRUITING

    Lyon, Auvergne-Rhône-Alpes, 69500, France

  • Hospital Alvaro Cunqueiro

    RECRUITING

    Vigo, Pontevedra, 36312, Spain

  • Ospedale Luigi Sacco

    WITHDRAWN

    Milan, Milan, 20157, Italy

  • Ospedale San Raffaele - Cardiac

    RECRUITING

    Milan, Lombardy, 1350, Italy

  • Ospedale Umberto I

    RECRUITING

    Turin, Piedmont, 10128, Italy

  • Policlinico S.Orsola-Malpighi

    RECRUITING

    Bologna, Bologna, 40138, Italy

  • Tartu University Hospital

    RECRUITING

    Tartu, 50406, Estonia

  • University of Wisconsin Hospital and Clinics

    WITHDRAWN

    Madison, Wisconsin, 53792, United States

  • Universitätsklinikum Jena

    RECRUITING

    Jena, Thuringia, 07740, Germany

  • Universitätsklinikum Würzburg

    COMPLETED

    Würzburg, Bavaria, 97080, Germany

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