ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices

Heart Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05174442
• Other study ID #: Occ2021_03
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Heart Diseases

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