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Post-market Clinical Follow-up Study on the Performance and Safety of Coronary Artery Perfusion Cannula Used During Cardiopulmonary Bypass

NCT07620847 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-06-02

No results posted yet for this study

Summary

Prior to the implementation of the Medical Device Regulation (MDR), clinical evaluation of older devices was carried out by Notified Bodies (MBs) based on clinical data obtained from equivalent devices, and CE certification was granted to devices exhibiting similar characteristics. Following the transition to the MDR, the European Union Commission's MEDDEV 2.12/2 guidance emphasizes that MBs, which issued CE certificates according to previous practices, should organize Post Marketing Clinical Follow-up (PMCF) studies to verify the performance and safety of the device throughout its lifecycle in accordance with its intended use for which it bears the CE mark. Thus, PMCF studies are planned to demonstrate that medical devices that were previously CE marked according to previous practices are used safely for patients throughout their lifecycles.

Conditions

  • Cardiopulmonary Bypass

Interventions

DEVICE

coronary artery perfusion cannula

The Coronary Artery Perfusion Cannula is designed for the direct administration of cardioplegic solution into the coronary arteries during cardiopulmonary bypass surgery.

Sponsors & Collaborators

  • Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-09-01
Completion
2026-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620847 on ClinicalTrials.gov