Status:
RECRUITING
ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices
Lead Sponsor:
Occlutech International AB
Conditions:
Heart Diseases
Eligibility:
All Genders
Brief 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 ...
Detailed Description
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 ...
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.
Key Trial Info
Start Date :
October 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
685 Patients enrolled
Trial Details
Trial ID
NCT05174442
Start Date
October 14 2021
End Date
January 1 2027
Last Update
December 4 2025
Active Locations (36)
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1
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
2
Kliniken Maria Hilf GmbH
Mönchengladbach, Germany
3
Klinikum der Universität München
München, Germany, 81377
4
Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi
Adana, Balcalı, Turkey (Türkiye), 01330