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

Occlutech International AB685 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

685

Conditions

Heart Diseases

Eligibility

Medical Language ↔ Plain English

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.

Locations (36)

Universitätsklinikum Erlangen

Erlangen, Germany

RECRUITING

Kliniken Maria Hilf GmbH

Mönchengladbach, Germany

ACTIVE_NOT_RECRUITING

Klinikum der Universität München

München, Germany

RECRUITING

Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi

Adana, Balcalı, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

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.