Clinical trial Recruiting at 28 sites Observational

Monitoring the safety and performance of Occlutech medical devices for heart procedures

Official title: A Registry-based, Multicenter, International, Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices:Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP), Occlutech Sizing Balloon (OSB) Used During to Implantation Procedures of Cardiac Implant Devices

Run by Occlutech International AB · NCT05174442 · Data updated 2026-11-12

This study is testing how safe and effective Occlutech medical devices are for heart procedures by collecting feedback from doctors using them in everyday practice.

More Heart Diseases trials

Quick facts

Study typeObservational
SexAll
Enrollment685 (estimated)
SponsorOcclutech International AB
Industry-sponsored
Locations36 sites (Erlangen and 35 other locations)
StatusRecruiting
StartedOctober 14, 2021
Main results expectedJanuary 1, 2027
Study endsJanuary 1, 2027
Registry record updatedDecember 4, 2025
Trial IDNCT05174442 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients who have undergone implantation procedures with Occlutech accessory medical devices and cardiac implants.

Probably not a fit

Patients who have not had any procedures involving Occlutech devices will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international, multicenter registry aims to assess the safety, performance, and usability of Occlutech accessory medical devices used in catheter-based interventions for cardiac implants. Investigators will complete surveys to evaluate the success of implantation procedures, any adverse events, and the overall user experience with the devices. The study is non-invasive and non-randomized, focusing on real-world data collected from experienced physicians during routine clinical practice. The findings will help ensure the devices meet safety and usability standards.

Why it matters

Potential benefit: If successful, this study could enhance the safety and effectiveness of cardiac implantation procedures using Occlutech devices.

How similar studies have gone: Other studies assessing the safety and performance of medical devices have shown success, indicating that this approach is supported by prior evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Universitätsklinikum Erlangen
    Erlangen, Germany
    Recruiting
  • Klinikum der Universität München
    München, Germany
    Recruiting
  • Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi
    Adana, Balcalı, Turkey (Türkiye)
    Recruiting
  • İnönü Üniversitesi Tıp Fakültesi Hastanesi
    Malatya, Battalgazi, Turkey (Türkiye)
    Recruiting
  • İzmir Şehir Hastanesi
    Izmir, Bayraklı, Turkey (Türkiye)
    Recruiting
  • Aydın Adnan Menderes Üniversitesi Hastanesi
    Aydin, Efeler, Turkey (Türkiye)
    Recruiting
Show 30 more locations
  • Bezmialem Tıp Fakültesi Hastanesi
    Istanbul, Fatih, Turkey (Türkiye)
    Recruiting
  • İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi
    Istanbul, Küçükçekmece, Turkey (Türkiye)
    Recruiting
  • İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi
    Istanbul, Küçükçekmece, Turkey (Türkiye)
    Recruiting
  • Karaman Eğitim ve Araştırma Hastanesi
    Karaman, Merkez, Turkey (Türkiye)
    Recruiting
  • Dicle Üniversitesi Tıp Fakültesi Hastanesi
    Diyarbakır, Sur, Turkey (Türkiye)
    Recruiting
  • Ankara Etlik Şehir Hastanesi
    Ankara, Yenimahalle, Turkey (Türkiye)
    Recruiting
  • Adana City Training and Research Hospital
    Adana, Turkey (Türkiye)
    Recruiting
  • Hacettepe Üniversitesi Hastanesi
    Ankara, Turkey (Türkiye)
    Recruiting
  • Gazi University Medical Faculty Hospital Adult
    Ankara, Turkey (Türkiye)
    Recruiting
  • Gazi University Medical Faculty Hospital Pediatric
    Ankara, Turkey (Türkiye)
    Recruiting
  • Antalya Training and Research Hospital (Adult)
    Antalya, Turkey (Türkiye)
    Recruiting
  • Antalya Training and Research Hospital (Pediatric)
    Antalya, Turkey (Türkiye)
    Recruiting
  • Pamukkale Üniversitesi Klinik Uygulama ve Araştırma Merkezi Hastanesi
    Denizli, Turkey (Türkiye)
    Recruiting
  • Eskişehir Osmangazi University Adult
    Eskişehir, Turkey (Türkiye)
    Recruiting
  • Eskişehir Osmangazi University Pediatric
    Eskişehir, Turkey (Türkiye)
    Recruiting
  • Isparta Süleyman Demirel Üniversitesi Araştırma ve Uygulama Hastanesi
    Isparta, Turkey (Türkiye)
    Recruiting
  • Istanbul Basaksehir Cam and Sakura City Hospital (Pediatric)
    Istanbul, Turkey (Türkiye)
    Recruiting
  • Kocaeli University Hospital
    Kocaeli, Turkey (Türkiye)
    Recruiting
  • Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi
    Konya, Turkey (Türkiye)
    Recruiting
  • Mardin Artuklu Üniversitesi Tıp Fakültesi Hastanesi
    Mardin, Turkey (Türkiye)
    Recruiting
  • S.B.Ü Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi
    Trabzon, Turkey (Türkiye)
    Recruiting
  • Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama Hastanesi
    Gaziantep, Şehitkamil, Turkey (Türkiye)
    Recruiting
  • Kliniken Maria Hilf GmbH
    Mönchengladbach, Germany
    Active not recruiting
  • Antalya Akdeniz Üniversitesi Hastanesi
    Antalya, Konyaaltı, Turkey (Türkiye)
    Withdrawn
  • Medicana International Ankara Hastanesi
    Ankara, Söğütözü, Turkey (Türkiye)
    Not yet recruiting
  • SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
    Bursa, Turkey (Türkiye)
    Not yet recruiting
  • Dicle Üniversitesi Tıp Fakültesi Sağlık ve Araştırma Hastanesi
    Diyarbakır, Turkey (Türkiye)
    Not yet recruiting
  • Istanbul Basaksahir Cam and Sakura City Hospital(Adult)
    Istanbul, Turkey (Türkiye)
    Not yet recruiting
  • Istanbul Prof. Dr. Suleyman Yalcin City Hospital
    Istanbul, Turkey (Türkiye)
    Not yet recruiting
  • Mersin University Faculty of Medicine Hospital
    Mersin, Turkey (Türkiye)
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.