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

Heart device registry launches to monitor safety in routine care

NCT ID NCT06590467

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Updated 4 times

Summary

This registry will follow 2,500 people who receive Abbott heart devices, such as implants for holes in the heart or replacement heart valves. The goal is to check how safe and effective these devices are when used in everyday hospital practice. Data will be collected from standard follow-up visits to meet European regulatory requirements.

What this could mean

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

Active substance
Amplatzer occlusion devices and Epic surgical tissue heart valves
What this could lead to
If successful, this registry will confirm that these heart devices are safe and work well in everyday medical practice, helping meet regulatory standards.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results depend on routine care and may vary across hospitals.

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 2,500 people

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

Started

Aug 2024

Expected to finish

Nov 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

This Registry is open to enroll subjects of all genders and ages from the general population who undergo a procedure that use at least one Abbott SH device included in this Registry (including unsuccessful implants). Subjects must meet all eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care. Patients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the timeframe specified in the device-specific appendices of the protocol (Amplatzer cohort: consent within 7days of procedure // Cardiac Surgery (The ENDURE Study) cohort: consent within 6 months (183 days) of the implant procedure)

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. Subject is expected to undergo an implant attempt using one or more Abbott Structural Heart devices covered in this Registry or has previously undergone an implant attempt within the timeframes specified in the device-specific appendices. 2. Subject is willing and able to comply with the site's standard of care follow-up schedule. 3. Subject is willing to provide appropriate informed consent for Registry participation. For deceased subjects enrolled retrospectively, local regulations and EC/IRB recommendations regarding consent and the protection of personal data must be followed. Exclusion Criteria: 1\. Subject is participating in another clinical study that would affect the results of this Registry.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Asd - atrial septal defect are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

atrial septal defect heart disorder heart valve disorder patent foramen ovale ventricular septal defect

As listed by the trial registrant

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

Asd - atrial septal defect Heart diseases Pfo - patent foramen ovale Pivsd - post infarct muscular ventricular septal defect Valvular heart disease VSD - muscular ventricular septal defect

How to take part

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

  1. The places running it

    36 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

  • A.O.U. Citta della Salute e della Scienza di Torino

    RECRUITING

    Turin, Piedmont, 10126, Italy

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, Tuscany, 56126, Italy

  • Baptist Hospital of Miami

    NOT_YET_RECRUITING

    Miami, Florida, 33176, United States

  • CHU Rennes, Pontchaillou

    RECRUITING

    Rennes, Brittan, 35033, France

  • Children's Health Ireland (CHI)

    RECRUITING

    Crumlin, Dublin, D12N512, Ireland

  • Deutsches Herzzentrum München des Freistaates Bayern

    RECRUITING

    München, Bavaria, 80636, Germany

  • Deutsches Herzzentrum der Charité

    RECRUITING

    Berlin, State of Berlin, 13353, Germany

  • Hopital Haut Leveque

    RECRUITING

    Pessac, 33604, France

  • Hospital Infantil Sant Joan De Deu

    RECRUITING

    Esplugues de Llobregat, Catalonia, 08950, Spain

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario de la Paz - Pediatrico

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Virgen de Rocio

    RECRUITING

    Seville, Spain, 41013, Spain

  • Hôpital Marie-Lannelongue

    RECRUITING

    Le Plessis-Robinson, 92350, France

  • IRCCS Policlinico San Donato - Cardio

    RECRUITING

    San Donato Milanese, Lombardy, 20097, Italy

  • Klinikum Links der Weser

    RECRUITING

    Bremen, Free Hanseatic City of Bremen, 28277, Germany

  • Mayo Clinic Health System - Eau Claire Hospital, Inc.

    NOT_YET_RECRUITING

    Eau Claire, Wisconsin, 54702, United States

  • MedStar Washington Hospital Center

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • New York Presbyterian Hospital/Cornell University

    NOT_YET_RECRUITING

    New York, New York, 10065, United States

  • Odense University Hospital

    RECRUITING

    Odense, Southern Denmark, 5000, Denmark

  • Policlinico San Donato

    RECRUITING

    San Donato Milanese, Lombardy, 20097, Italy

  • Robert Wood Johnson University Hospital

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Royal Brompton Hospital

    RECRUITING

    London, UK, SW3 6NP, United Kingdom

  • Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG

    RECRUITING

    Bad Rothenfelde, 32545, Germany

  • Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Slaskie Centrum Chorob Serca

    RECRUITING

    Zabrze, Silesian Voivodeship, 41-800, Poland

  • St. Thomas Hospital

    RECRUITING

    London, SE1 7EH, United Kingdom

  • Städt. Klinikum Braunschweig gGmbH

    RECRUITING

    Braunschweig, L Saxon, 38126, Germany

  • Tartu University Hospital

    RECRUITING

    Tartu, Tartu, 50406, Estonia

  • The Cleveland Clinic Foundation

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • USC University Hospital

    NOT_YET_RECRUITING

    Los Angeles, California, 90033, United States

  • Universitatsklinikum Jena

    RECRUITING

    Jena, Germany, 07747, Germany

  • University of Pennsylvania

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington Medical Center

    NOT_YET_RECRUITING

    Seattle, Washington, 98195, United States

  • Washington University School of Medicine

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

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