Characterization of Aortic Tissue at Reoperation

CryoLife

Status: Completed

Conditions: Aortic Aneurysm; Aortic Dissection

Study type: Observational

Funder types: Industry

Identifiers

NCT02375542

BIO1301.001M

Details and patient eligibility

About

This study will analyse factors contributing to cardiac re-operation to determine causative effects

Full description

This study will collect clinical data on the characteristics of aortic tissue on which BioGlue has been applied during a previous cardiovascular surgery. This is a post market surveillance study.

Enrollment: 11 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects undergoing an aortic re-operation
• Subject has had BioGlue used during previous aortic surgery
• Subject is willing and able to give written informed consent for participation

Exclusion criteria

• Subject with a history of vasculitis
• Subject with active infection (endocarditis)
• Subject with a history of chronic inflammatory condition which may have led to ongoing tissue damage
• Subject with a history of auto immune disease

Trial design

11 participants in 1 patient group

Cardiac Reoperation

Description:

Patients who have previously undergone a cardiac operation with the use of BioGlue and are now undergoing a reoperation