RecruitingNot Applicable

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

Germany, Turkey (Türkiye)685 participantsStarted 2021-10-14

Plain-language 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.

Who can participate

SexALL

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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.

What they're measuring

Occurence of safety events

Timeframe: 6 months

Trial details

NCT IDNCT05174442

SponsorOcclutech International AB

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-01-01

Contact for this trial

Gönül Sönmez Utkun

+90 542 826 11 95 gonul.sonmezutkun@occlutech.com

View on ClinicalTrials.gov More Heart Diseases trials