Aortic Dissection, Aortic Valve Disease, Ascending Aorta Abnormality
Conditions
Keywords
Aortic Root Replacement, Ascending Aorta Replacement, Valved Graft, CAVGJ, VAVGJ
Brief summary
Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.
Interventions
DEVICEVAVGJ
Replacement of the aortic valve and ascending aorta
DEVICECAVGJ
Replacement of the aortic valve and ascending aorta
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| annualized event rate of all-cause mortality | 5 Years | Primary Safety Endpoint |
| annualized event rate of reintervention | 5 Years | Primary Effectiveness Endpoint |
Countries
Austria, Denmark, France, Germany, Greece, Italy, Poland, Spain, United Kingdom, United States
Contacts
CONTACTPaolo Amato
CONTACTKarine Miquel
Outcome results
None listed