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Heart device watchdog: 5,000-Patient registry launches

NCT ID NCT04241328

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 2 times

Summary

This registry is an observational study that will follow 5,000 people who receive a Medtronic heart surgery device. Its goal is to confirm the devices are safe and work well in everyday use, and to spot any new risks. No new treatment is being tested—just real-world monitoring.

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 5,000 people

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

Started

Jan 2020

Expected to finish

Dec 2026

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

All consecutive subjects with the intent of being treated or treated (up to discharge from treating hospital) with a market-approved Medtronic CS product, are candidates to be enrolled. The Investigator will determine subject eligibility in SYMBIOSIS based upon the inclusion/exclusion criteria. If a subject meets all inclusion and none of the exclusion criteria, they will be informed about the SYMBIOSIS Registry. SYMBIOSIS will collect data of numerous patient conditions for which Medtronic CS products are being used.

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: * Subject or legally authorized representative provides written data release and/or informed consent per institution and/or geographical requirements prior to discharge from participating registry hospital. * Subject will undergo or underwent a procedure in which an eligible Medtronic CS product is/was used. Exclusion Criteria: * Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder

As listed by the trial registrant

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

Cardiovascular diseases

How to take part

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

  1. The places running it

    6 sites in 4 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

  • AKH Wien

    RECRUITING

    Vienna, 1090, Austria

  • CHU d'Angers

    COMPLETED

    Angers, France

  • Catharina Ziekenhuis

    COMPLETED

    Eindhoven, 5623 EJ, Netherlands

  • Clinique Claude Bernard

    TERMINATED

    Metz, 57070, France

  • Deutsches Herzzentrum München

    RECRUITING

    Munich, 80636, Germany

  • Haukeland Universitetssjukehus

    SUSPENDED

    Bergen, Norway

  • Herz- und Diabeteszentrum NRW

    RECRUITING

    Bad Oeynhausen, Germany

  • Hospital Clinic Barcelona

    COMPLETED

    Barcelona, 08036, Spain

  • Maastricht University Medical Center (MUMC+)

    ACTIVE_NOT_RECRUITING

    Maastricht, 6229 HX, Netherlands

  • Onassis Hospital

    ACTIVE_NOT_RECRUITING

    Athens, Greece

  • St. Antonius Ziekenhuis

    RECRUITING

    Nieuwegein, Netherlands

  • UZ Leuven

    COMPLETED

    Leuven, Belgium

  • Uniklinik RWTH Aachen

    RECRUITING

    Aachen, Germany

  • Ziekenhuis Oost-Limburg

    COMPLETED

    Genk, 3600, Belgium

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