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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Page 1 of 9 (36 locations)

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