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Post-Market Clinical Follow-up Study on the Performance and Safety of the Aortic Root Cannula Used in Cardiopulmonary Bypass Surgery

NCT07628907 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-06-05

No results posted yet for this study

Summary

Prior to the implementation of the Medical Device Regulation (MDR), the clinical evaluation of existing devices was conducted by Notified Bodies (NBs) based on clinical data from equivalent devices, and CE marking was granted to devices demonstrating similar characteristics. Following the transition to the MDR, the European Commission's Guideline MEDDEV 2.12/2 noted that, compared to previous practices, Notified Bodies issuing CE certificates must verify the performance and safety of the device throughout its lifecycle in accordance with its intended use by conducting Post Marketing Clinical Follow-up (PMCF) studies are required to verify the performance and safety of the device in accordance with its intended use throughout its lifecycle. Consequently, PMCF studies are being planned to demonstrate that medical devices previously granted CE marking under the old practices can be used safely by patients throughout their lifecycle.

Conditions

  • Cardiopulmonary Bypass Surgery

Interventions

DEVICE

aortic root cannula

The Aortic Root Cannula and Vented Aortic Root Cannula are indicated for the administration of cardioplegic solutions during cardiac surgical procedures such as coronary artery bypass grafting, aortic valve replacement, mitral valve replacement, double valve replacement, and aortic valve replacement combined with coronary artery bypass grafting. The Aortic Root Cannula (35 cm) is indicated for use in minimally invasive surgeries.

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 NCT07628907 on ClinicalTrials.gov