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

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary and study completion dates: Oct 14, 2025 to Jan 1, 2027
    • Study sites: 34 to 36
    v8
  2. Enrollment target: 385 to 685
    • Study sites: 22 to 34
    v7
  3. Study sites: 17 to 22v6
  4. Site details revised at 3 of 17 sitesv5
  5. Study sites: 14 to 17v4
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  1. Enrollment target: 880 to 385v3 Show 4 more changesShow less
    • Primary endpoint revised
    • Study sites: 8 to 14
    • Study description expanded, about 177 words
    • Study title shortened, about 2 words
  2. Study sites: 2 to 8v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05174442
Lead Sponsor Occlutech International AB
Conditions
(from sponsor)		 Heart Diseases
Related terms Heart Diseases
Enrollment 685 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov