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.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 685 (estimated) |
| Sponsor | Occlutech International AB Industry-sponsored |
| Locations | 36 sites (Erlangen and 35 other locations) |
| Status | Recruiting |
| Started | October 14, 2021 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2027 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT05174442 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
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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
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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
- Study coordinator: Gönül Sönmez Utkun
- Email: gonul.sonmezutkun@occlutech.com
- Phone: +90 542 826 11 95
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.