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Heart implant tool safety under review in global registry

NCT ID NCT05174442

Knowledge-focused Sponsor: Occlutech International AB 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tracks the safety and performance of four accessory devices used during heart implant procedures. Researchers will collect data from about 685 participants across multiple countries by having doctors fill out surveys after each procedure. The goal is to monitor for any device-related problems, such as dislocation or damage to the heart, and to see how well the tools work.

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 685 people

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

Started

Oct 2021

Expected to finish

Jan 2027

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 subjects who underwent implantation procedure with an Occlutech accessory medical device and cardiac implants can be included. Preconditions depend exclusively on the requirements outlined in the applicable Instruction for Use of the implant and the accessories.

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: * Inclusion Criteria depend exclusively on the requirements outlined in the applicable Instruction for Use for accessory medical devices and cardiac implant devices. All subjects who underwent implantation procedure with an Occlutech accessory medical device and cardiac implants can be included Exclusion Criteria: * Exclusion Criteria depend exclusively on the requirements outlined in the applicable Instruction for Use and if applicable in the corresponding protocol of the investigation on the Occlutech implant devices.

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Conditions

The condition(s) this trial relates to.

heart disorder

As listed by the trial registrant

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

Heart diseases

How to take part

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

  1. The places running it

    34 sites in 2 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

  • Adana City Training and Research Hospital

    RECRUITING

    Adana, Turkey (Türkiye)

  • Ankara Etlik Şehir Hastanesi

    RECRUITING

    Ankara, Yenimahalle, 06170, Turkey (Türkiye)

  • Antalya Akdeniz Üniversitesi Hastanesi

    WITHDRAWN

    Antalya, Konyaaltı, 07070, Turkey (Türkiye)

  • Antalya Training and Research Hospital (Adult)

    RECRUITING

    Antalya, Turkey (Türkiye)

  • Antalya Training and Research Hospital (Pediatric)

    RECRUITING

    Antalya, Turkey (Türkiye)

  • Aydın Adnan Menderes Üniversitesi Hastanesi

    RECRUITING

    Aydin, Efeler, 09100, Turkey (Türkiye)

  • Bezmialem Tıp Fakültesi Hastanesi

    RECRUITING

    Istanbul, Fatih, 34093, Turkey (Türkiye)

  • Dicle Üniversitesi Tıp Fakültesi Hastanesi

    RECRUITING

    Diyarbakır, Sur, 21280, Turkey (Türkiye)

  • Dicle Üniversitesi Tıp Fakültesi Sağlık ve Araştırma Hastanesi

    NOT_YET_RECRUITING

    Diyarbakır, 21100, Turkey (Türkiye)

  • Eskişehir Osmangazi University Adult

    RECRUITING

    Eskişehir, Turkey (Türkiye)

  • Eskişehir Osmangazi University Pediatric

    RECRUITING

    Eskişehir, Turkey (Türkiye)

  • Gazi University Medical Faculty Hospital Adult

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Gazi University Medical Faculty Hospital Pediatric

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama Hastanesi

    RECRUITING

    Gaziantep, Şehitkamil, 27310, Turkey (Türkiye)

  • Hacettepe Üniversitesi Hastanesi

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Isparta Süleyman Demirel Üniversitesi Araştırma ve Uygulama Hastanesi

    RECRUITING

    Isparta, 32260, Turkey (Türkiye)

  • Istanbul Basaksahir Cam and Sakura City Hospital(Adult)

    NOT_YET_RECRUITING

    Istanbul, Turkey (Türkiye)

  • Istanbul Basaksehir Cam and Sakura City Hospital (Pediatric)

    RECRUITING

    Istanbul, Turkey (Türkiye)

  • Istanbul Prof. Dr. Suleyman Yalcin City Hospital

    NOT_YET_RECRUITING

    Istanbul, Turkey (Türkiye)

  • Karaman Eğitim ve Araştırma Hastanesi

    RECRUITING

    Karaman, Merkez, 70200, Turkey (Türkiye)

  • Kliniken Maria Hilf GmbH

    ACTIVE_NOT_RECRUITING

    Mönchengladbach, Germany

  • Klinikum der Universität München

    RECRUITING

    München, 81377, Germany

  • Kocaeli University Hospital

    RECRUITING

    Kocaeli, Turkey (Türkiye)

  • Mardin Artuklu Üniversitesi Tıp Fakültesi Hastanesi

    RECRUITING

    Mardin, 47200, Turkey (Türkiye)

  • Medicana International Ankara Hastanesi

    NOT_YET_RECRUITING

    Ankara, Söğütözü, 06520, Turkey (Türkiye)

  • Mersin University Faculty of Medicine Hospital

    NOT_YET_RECRUITING

    Mersin, Turkey (Türkiye)

  • Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi

    RECRUITING

    Konya, 142080, Turkey (Türkiye)

  • Pamukkale Üniversitesi Klinik Uygulama ve Araştırma Merkezi Hastanesi

    RECRUITING

    Denizli, 20160, Turkey (Türkiye)

  • S.B.Ü Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi

    RECRUITING

    Trabzon, 61040, Turkey (Türkiye)

  • SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

    NOT_YET_RECRUITING

    Bursa, 16310, Turkey (Türkiye)

  • Universitätsklinikum Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi

    RECRUITING

    Adana, Balcalı, 01330, Turkey (Türkiye)

  • İnönü Üniversitesi Tıp Fakültesi Hastanesi

    RECRUITING

    Malatya, Battalgazi, 44280, Turkey (Türkiye)

  • İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi

    RECRUITING

    Istanbul, Küçükçekmece, 34303, Turkey (Türkiye)

  • İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi

    RECRUITING

    Istanbul, Küçükçekmece, 34303, Turkey (Türkiye)

  • İzmir Şehir Hastanesi

    RECRUITING

    Izmir, Bayraklı, 35540, Turkey (Türkiye)

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