CardioRoot Post-Marketing Surveillance Registry

Maquet

Status: Completed

Conditions: Cardiovascular Surgical Procedure

Treatments: Device: CardioRoot graft

Study type: Observational

Funder types: Industry

Identifiers

NCT01609270

MCV00008317

Details and patient eligibility

About

Post-marketing surveillance registry of the CardioRoot graft.

Full description

Study objective is to monitor the performance and safety of CardioRoot vascular grafts implanted in a thoracic position. Patient survival rates will be monitored as well as immediate and long-term complications.

Enrollment: 52 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients requiring a CardioRoot graft as per the CardioRoot Instructions for Use (IFU)

Exclusion criteria

• patients with contra-indications per CardioRoot IFU
• patients requiring consecutive aortic surgery
• patients with coronary artery disease
• patients who require urgent or emergent surgery

Trial design

52 participants in 1 patient group

CardioRoot

Description:

All subjects receive the CardioRoot graft at baseline implant procedure.

Treatment:

Device: CardioRoot graft