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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05174442
Other study ID # Occ2021_03
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 14, 2021
Est. completion date October 14, 2025

Study information

Verified date June 2023
Source Occlutech International AB
Contact Gönül Sönmez Utkun
Phone +90 542 826 11 95
Email gonul.sonmezutkun@occlutech.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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. A survey (questionnaire) of each accessory medical device should be completed by investigator in order to assess safety of the accessory by success of implantation procedure, occurrence of adverse events during implantation procedure or as late term effects resulting from implantation procedure, user harm related to the accessory, procedure, reported device deficiencies related to the accessory. The Surveys (questionnaires) also include questions related to performance, usability and compatibility with devices and other accessories. Subjects should be treated according to instructions-for-use of the implants and accessories and according to clinical routine. The devices must have been used exclusively by physicians who are experienced in cardiac catheterization techniques and who are experienced in using the products in the process of interventional operations.


Recruitment information / eligibility

Status Recruiting
Enrollment 385
Est. completion date October 14, 2025
Est. primary completion date October 14, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Uniklinik Erlangen Erlangen
Germany Kliniken Maria Hilf GmbH Mönchengladbach
Turkey Adana City Training and Research Hospital Adana
Turkey Çukurova Üniversitesi Tip Fakültesi Balcali Hastanesi Adana Balcali
Turkey Gazi University Medical Faculty Hospital Adult Ankara
Turkey Gazi University Medical Faculty Hospital Pediatric Ankara
Turkey Saglik Bilimleri Üniversitesi Diskapi Yildirim Beyazit Egitim ve Arastirma Hastanesi Ankara Diskapi
Turkey Antalya Training and Research Hospital (Adult) Antalya
Turkey Antalya Training and Research Hospital (Pediatric) Antalya
Turkey Aydin Adnan Menderes Üniversitesi Hastanesi Aydin Efeler
Turkey Dicle Üniversitesi Tip Fakültesi Hastanesi Diyarbakir Sur
Turkey Eskisehir Osmangazi University Adult Eskisehir
Turkey Eskisehir Osmangazi University Pediatric Eskisehir
Turkey Gaziantep Üniversitesi Sahinbey Arastirma ve Uygulama Hastanesi Gaziantep Sehitkamil
Turkey Bezmialem Tip Fakültesi Hastanesi Istanbul Fatih
Turkey Istanbul Basaksahir Cam and Sakura City Hospital(Adult) Istanbul
Turkey Istanbul Basaksehir Cam and Sakura City Hospital (Pediatric) Istanbul
Turkey Istanbul Prof. Dr. Suleyman Yalcin City Hospital Istanbul
Turkey Izmir Saglik Bilimleri Üniversitesi Tepecik Egitim Ve Arastirma Hastanesi Izmir Konak
Turkey Kocaeli University Hospital Kocaeli
Turkey Inönü Üniversitesi Tip Fakültesi Hastanesi Malatya Battalgazi
Turkey Mersin University Faculty of Medicine Hospital Mersin

Sponsors (1)

Lead Sponsor Collaborator
Occlutech International AB

Countries where clinical trial is conducted

Germany,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurence of safety events The primary safety endpoint is defined as the rate of incidences of (peri-) procedural adverse events / rate of (serious) adverse device effects ((S)ADEs) during implantation or as late effects of implantation procedure. A serious adverse device effect (SADE) is defined as an event that is clearly caused by the device such as:
device dislocation (during the procedures with OPP, OOP,ODS)
embolization related with procedure and accessories
Late effect of implantation procedure: damage to the vessels and heart caused by the accessories
any circumstances that require device removal related with procedure or accessories used during the implantation
Signs of thrombosis
6 months
Secondary Performance, usability: will be assessed in terms of mechanical performance, procedural data by completing the survey (questionnaire) for each accessory with grading. Compatibility of ODS, OPP, OOP with cardiac implant devices or/and other accessory medical devices. 6 months
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