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

Launched by OCCLUTECH INTERNATIONAL AB · Dec 29, 2021

Keywords

ClinConnect Summary

The ACCESS Registry is a study designed to check the safety and performance of certain medical devices made by Occlutech that help doctors implant heart devices. In this study, researchers will collect feedback from healthcare providers about how these accessory devices—the Occlutech Delivery Set, Pistol Pusher, Occlusions-Pusher, and Sizing Balloon—are working during procedures to place heart implants. This is a non-invasive study, meaning participants won’t have to undergo any additional medical procedures just for this study; instead, healthcare providers will fill out surveys about their experiences.

To be eligible for this study, you need to have had a heart implant procedure using one of the Occlutech accessory devices. There are specific guidelines that determine who can participate based on the instructions provided for these devices. This study is currently recruiting participants of all ages and genders. If you take part, you can expect to contribute to important information that helps ensure these devices are safe and effective for patients in the future.

Gender

ALL

Eligibility criteria

• 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.