NCT05174442 ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices
| NCT ID | NCT05174442 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Occlutech International AB |
| Condition | Heart Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 685 participants |
| Start Date | 2021-10-14 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 685 participants in total. It began in 2021-10-14 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05174442 clinical trial?
This trial is open to participants of all sexes, studying Heart Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05174442 currently recruiting?
Yes, NCT05174442 is actively recruiting participants. Contact the research team at gonul.sonmezutkun@occlutech.com for enrollment information.
Where is the NCT05174442 trial being conducted?
This trial is being conducted at Erlangen, Germany, Mönchengladbach, Germany, München, Germany, Adana, Turkey (Türkiye) and 11 additional locations.
Who is sponsoring the NCT05174442 clinical trial?
NCT05174442 is sponsored by Occlutech International AB. The trial plans to enroll 685 participants.