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

Recruiting

• Conditions: Heart Diseases

• Registration Number: NCT05174442
• Lead Sponsor: Occlutech International AB

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-10-14
• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2021-12-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-15
• Last Update Posted: 2025-07-18
• Primary Completion: 2025-10-14
• Study Completion: 2025-10-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 685

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurence of safety events	6 months	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

Secondary Outcome Measures

Name	Time	Method
Performance, usability:	6 months	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.

Trial Locations

Locations (33)

Klinikum der Universität München; 🇩🇪 München, Germany

İzmir Şehir Hastanesi; 🇹🇷 İzmir, Bayraklı, Turkey

İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi; 🇹🇷 İstanbul, Küçükçekmece, Turkey

Medicana International Ankara Hastanesi; 🇹🇷 Ankara, Söğütözü, Turkey

Ankara Etlik Şehir Hastanesi; 🇹🇷 Ankara, Yenimahalle, Turkey

Hacettepe Üniversitesi Hastanesi; 🇹🇷 Ankara, Turkey

SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi; 🇹🇷 Bursa, Turkey

Pamukkale Üniversitesi Klinik Uygulama ve Araştırma Merkezi Hastanesi; 🇹🇷 Denizli, Turkey

Dicle Üniversitesi Tıp Fakültesi Sağlık ve Araştırma Hastanesi; 🇹🇷 Diyarbakır, Turkey

Isparta Süleyman Demirel Üniversitesi Araştırma ve Uygulama Hastanesi; 🇹🇷 Isparta, Turkey

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