Clinical Trial

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

Recruiting
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-12-29; most recent amendment 2025-12-03.
Trial Details
NCT Number NCT05174442
Lead Sponsor Occlutech International AB
Conditions Heart Diseases
Enrollment 685 participants
Start Date 2021-10-14
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-04