NCT04754217

Valved Graft PMCF Study

Valved Graft Post-Market Clinical Follow-up Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 260 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Aortic Valve Disease
• Ascending Aorta Abnormality
• Aortic Dissection

Interventions

Type	Name	Description
DEVICE	VAVGJ	Replacement of the aortic valve and ascending aorta
DEVICE	CAVGJ	Replacement of the aortic valve and ascending aorta

Timeline

• Start date: 2021-07-13
• Primary completion: 2029-07-01
• Completion: 2029-09-01
• First posted: 2021-02-15
• Last updated: 2026-04-13

Locations

25 sites across 10 countries: United States, Austria, Denmark, France, Germany, Greece, Italy, Poland, Spain, United Kingdom