PremiCron Suture for Cardiac Valve Repair (PremiValve)

Aesculap

Status: Completed

Conditions: Aortic Valve Stenosis

Study type: Observational

Funder types: Industry

Identifiers

NCT04096859

AAG-O-H-1823

Details and patient eligibility

About

The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

198 participants in 1 patient group

PremiCron®

Description:

Assessment of PremiCron suture for cardiac valve reconstruction and replacement