International Registry to Monitor Safety, Performance, and Usability of Occlutech Accessory Devices for Cardiac Implant Procedures

What this Trial Is About

This research aims to evaluate the safety, performance, and usability of several Occlutech accessory medical devices used in heart disease treatment. These devices include the Occlutech Delivery Set ODS, Occlutech Pistol Pusher OPP, Occlutech Occlusions-Pusher OOP, and Occlutech Sizing Balloon OSB. The study is international, multicenter, non-randomized, and non-invasive, focusing on catheter-based implantation procedures for cardiac implants. The study involves physicians experienced in cardiac catheterization using these accessories during implantation procedures. Investigators complete detailed surveys to assess each devices safety, including success of implantation, adverse events during or after the procedure, user harm, and any device deficiencies. The surveys also evaluate the performance, usability, and compatibility of these accessories with other devices. Subjects receive treatment following standard clinical routines and specific instructions for use. Participants who have undergone implantation with an Occlutech accessory and cardiac implant are included. Researchers monitor safety events and assess device performance and usability over a 6-month period. Data is collected via investigator questionnaires, focusing on implantation outcomes and any related complications. The total participation duration varies depending on individual follow-up but includes at least 6 months of monitoring for safety and performance.

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