Evaluation of COVA™+ CARD in Adult Cardiac Surgery

Biom'Up

Status: Withdrawn

Conditions: Tolerance; Safety

Treatments: Device: cardiac surgery requiring a collagen membrane COVA™+

Study type: Observational

Funder types: Industry

Identifiers

NCT03140098

ETC 2017-002

Details and patient eligibility

About

The aim of this observational study is to evaluate the safety of the guided healing and adhesion prevention membrane, COVA™+ CARD, in adult cardiac surgery. The causality of the collagen membrane according to the occurrence of peri and post-operative complications will be evaluated.

Full description

Assessment of the safety of COVA™+ CARD, collagen membrane to prevent adhesion appearance, in cardiac surgery in adult patients:

• collection of post-operative complications, causality of the membrane
• collection of complications in the 3-month period after the surgery, causality of the membrane
• collection of peri-operative complications, causality of the membrane
• collection of complications, 3 months after the surgery
• assessment of the efficacy of COVA™+ CARD if re-operation
• assessment of the surgeon's satisfaction

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Cardiac surgery using COVA™+ CARD

Exclusion criteria

• In accordance with the instruction for use (IFU) of the medical device.
• Refusal of participation to the study