Recruiting

Occlutech Accessory Devices for Cardiac Implant Procedures

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Study Aim

The study aims to observe the safety of Occlutech accessory devices during cardiac implant procedures by monitoring for any adverse events or effects in individuals undergoing these procedures.

What is being collected

Data Collection

Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: October 2021
See protocol details

Summary

Principal SponsorOcclutech International AB
Study ContactGönül Sönmez UtkunMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 14, 2021

Actual date on which the first participant was enrolled.

This study is designed to monitor the safety and performance of several Occlutech accessory devices used during heart implant procedures. These devices—Occlutech Delivery Set, Occlutech Pistol Pusher, Occlutech Occlusions-Pusher, and Occlutech Sizing Balloon—are used in catheter-based interventions to place cardiac implants. The study aims to ensure these tools are safe and effective when used by experienced physicians. By focusing on these aspects, the study aims to improve the procedures for patients needing heart implants, ensuring they are as safe and efficient as possible. Participants in this study are not patients but the physicians using these devices. They complete surveys after using the devices during implant procedures. These surveys ask about the success of the implantation, any adverse effects during or after the procedure, and any harm or deficiencies related to the devices. The study also gathers data on how well the devices perform and how easy they are to use. By analyzing the survey responses, the study assesses the overall safety and effectiveness of the devices in real-world clinical settings.

Official TitleA 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
NCT05174442
Principal SponsorOcclutech International AB
Study ContactGönül Sönmez UtkunMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

685 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart Diseases

Criteria

2 inclusion criteria required to participate
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

1 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 36 locations

Recruiting

Universitätsklinikum Erlangen

Erlangen, GermanyOpen Universitätsklinikum Erlangen in Google Maps
Recruiting

Klinikum der Universität München

München, Germany
Recruiting

Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi

Adana, Turkey (Türkiye)
Recruiting

İnönü Üniversitesi Tıp Fakültesi Hastanesi

Malatya, Turkey (Türkiye)
Recruiting
36 Study Centers
Occlutech Accessory Devices for Cardiac Implant Procedures | PatLynk