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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (36)

More Occlutech International AB trials in Germany

Other trials for the same condition