Valved Graft PMCF Study

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

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Key information

Conditions

Aortic Valve Disease Acute Aortic Syndrome Aneurysm Aortic Diseases Aortic Dissection Ascending Aorta Abnormality Cardiovascular Diseases Dissection, Blood Vessel Heart Diseases Heart Valve Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik Floridsdorf, Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VAVGJ

Device

Replacement of the aortic valve and ascending aorta

CAVGJ

Device

Replacement of the aortic valve and ascending aorta

Primary outcomes

annualized event rate of all-cause mortality

Time frame: 5 Years

Primary Safety Endpoint
annualized event rate of reintervention

Time frame: 5 Years

Primary Effectiveness Endpoint

Study contacts

Contact information is provided by the study sponsor or research team.

Karine Miquel

CONTACT

[email protected]

+32 479 60 01 07

Paolo Amato

CONTACT

[email protected]

+39 335 61 40 573

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Valved Graft Post-Market Clinical Follow-up Study

Important dates

Study start: 2021
Primary completion: 2029
Study completion: 2029
First posted: Feb 15, 2021
Registry last updated: Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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