Valved Graft PMCF Study

Abbott

Status: Enrolling

Conditions: Ascending Aorta Abnormality; Aortic Valve Disease; Aortic Dissection

Treatments: Device: CAVGJ; Device: VAVGJ

Study type: Observational

Funder types: Industry

Identifiers

NCT04754217

ABT-CIP-10386

Details and patient eligibility

About

Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement

Exclusion criteria

• anticoagulation therapy intolerant
• active endocarditis
• anatomical or medical, surgical, psychological or social contraindications

Trial design

260 participants in 2 patient groups

Group 1

Description:

VAVGJ

Treatment:

Device: VAVGJ

Group 2

Description:

CAVGJ

Treatment:

Device: CAVGJ