ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices
Recruiting now
Conditions studied: Heart Diseases
In brief
The registry is an international, multicenter, non-randomized, non-invasive study to assess the safety, performance and usability of the Occlutech Accessories "Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP) and Occlutech Sizing Balloon (OSB)" used for implantation procedures (catheter-based interventions) of cardiac implants via completing surveys (questionnaires) for the accessory medical devices by the investigators.
Key facts
- Study ID
- NCT05174442
- Run by
- Occlutech International AB
- People needed
- 685
- Starts
- 2021-10-14
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2025-12-04
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama Hastanesi — Gaziantep, Şehitkamil, Turkey (Türkiye) (enrolling)
- Eskişehir Osmangazi University Pediatric — Eskişehir, Turkey (Türkiye) (enrolling)
- Isparta Süleyman Demirel Üniversitesi Araştırma ve Uygulama Hastanesi — Isparta, Turkey (Türkiye) (enrolling)
- Istanbul Basaksehir Cam and Sakura City Hospital (Pediatric) — Istanbul, Turkey (Türkiye) (enrolling)
- Kocaeli University Hospital — Kocaeli, Turkey (Türkiye) (enrolling)
- Necmettin Erbakan Üniversitesi Meram Tıp Fakültesi — Konya, Turkey (Türkiye) (enrolling)
- Mardin Artuklu Üniversitesi Tıp Fakültesi Hastanesi — Mardin, Turkey (Türkiye) (enrolling)
- S.B.Ü Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi — Trabzon, Turkey (Türkiye) (enrolling)
- Universitätsklinikum Erlangen — Erlangen, Germany (enrolling)
- Klinikum der Universität München — München, Germany (enrolling)
- Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi — Adana, Balcalı, Turkey (Türkiye) (enrolling)
- İnönü Üniversitesi Tıp Fakültesi Hastanesi — Malatya, Battalgazi, Turkey (Türkiye) (enrolling)
- İzmir Şehir Hastanesi — Izmir, Bayraklı, Turkey (Türkiye) (enrolling)
- Aydın Adnan Menderes Üniversitesi Hastanesi — Aydin, Efeler, Turkey (Türkiye) (enrolling)
- Bezmialem Tıp Fakültesi Hastanesi — Istanbul, Fatih, Turkey (Türkiye) (enrolling)
- İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi — Istanbul, Küçükçekmece, Turkey (Türkiye) (enrolling)
- İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi — Istanbul, Küçükçekmece, Turkey (Türkiye) (enrolling)
- Karaman Eğitim ve Araştırma Hastanesi — Karaman, Merkez, Turkey (Türkiye) (enrolling)
- Dicle Üniversitesi Tıp Fakültesi Hastanesi — Diyarbakır, Sur, Turkey (Türkiye) (enrolling)
- Ankara Etlik Şehir Hastanesi — Ankara, Yenimahalle, Turkey (Türkiye) (enrolling)
- Adana City Training and Research Hospital — Adana, Turkey (Türkiye) (enrolling)
- Hacettepe Üniversitesi Hastanesi — Ankara, Turkey (Türkiye) (enrolling)
- Gazi University Medical Faculty Hospital Adult — Ankara, Turkey (Türkiye) (enrolling)
- Gazi University Medical Faculty Hospital Pediatric — Ankara, Turkey (Türkiye) (enrolling)
- Antalya Training and Research Hospital (Adult) — Antalya, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.