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Monitoring the safety and performance of Occlutech medical devices for heart procedures

A Registry-based, Multicenter, International, Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices:Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP), Occlutech Occlusions-Pusher (OOP), Occlutech Sizing Balloon (OSB) Used During to Implantation Procedures of Cardiac Implant Devices

Observational Occlutech International AB · NCT05174442

This study is testing how safe and effective Occlutech medical devices are for heart procedures by collecting feedback from doctors using them in everyday practice.

Quick facts

Study typeObservational
Enrollment685 (estimated)
SexAll
SponsorOcclutech International AB Industry-sponsored
Locations36 sites (Erlangen and 35 other locations)
Trial IDNCT05174442 on ClinicalTrials.gov

What this trial studies

This international, multicenter registry aims to assess the safety, performance, and usability of Occlutech accessory medical devices used in catheter-based interventions for cardiac implants. Investigators will complete surveys to evaluate the success of implantation procedures, any adverse events, and the overall user experience with the devices. The study is non-invasive and non-randomized, focusing on real-world data collected from experienced physicians during routine clinical practice. The findings will help ensure the devices meet safety and usability standards.

Who should consider this trial

Good fit: Ideal candidates include patients who have undergone implantation procedures with Occlutech accessory medical devices and cardiac implants.

Not a fit: Patients who have not had any procedures involving Occlutech devices will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the safety and effectiveness of cardiac implantation procedures using Occlutech devices.

How similar studies have performed: Other studies assessing the safety and performance of medical devices have shown success, indicating that this approach is supported by prior evidence.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Erlangen and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart Diseases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.