Status:
COMPLETED
PremiCron Suture for Cardiac Valve Repair
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
B.Braun Surgical SA
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.
Eligibility Criteria
Inclusion
- Patients undergoing an elective primary open or minimal invasive surgery for a single or multiple cardiac valve reconstruction or / and replacement.
- Age ≥18 years
- Written informed consent
Exclusion
- Patients undergoing an elective primary cardiac valve reconstruction or / and replacement in combination with a coronary arterial bypass graft surgery.
- Emergency surgery
- Pregnancy
- Infective endocarditis
- Previous cardiac surgical intervention
- Known immunodeficiency or immunosuppression
- Participation or planned participation in another cardiovascular study before study follow-up is completed.
- Inability to give informed consent due to mental condition, mental retardation, or language barrier.
Key Trial Info
Start Date :
November 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 13 2022
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT04096859
Start Date
November 22 2019
End Date
January 13 2022
Last Update
June 22 2023
Active Locations (2)
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1
Robert Bosch KH Stuttgart
Stuttgart, Germany, 70376
2
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain, 08026