Valved Graft PMCF Study
Valved Graft Post-Market Clinical Follow-up Study
1 other identifier
observational
260
10 countries
25
Brief Summary
Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2021
CompletedFirst Posted
Study publicly available on registry
February 15, 2021
CompletedStudy Start
First participant enrolled
July 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
April 13, 2026
April 1, 2026
8 years
February 10, 2021
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
annualized event rate of all-cause mortality
Primary Safety Endpoint
5 Years
annualized event rate of reintervention
Primary Effectiveness Endpoint
5 Years
Study Arms (2)
Group 1
VAVGJ
Group 2
CAVGJ
Interventions
Eligibility Criteria
This study will enroll male and female subjects who will be undergoing replacement of a native or prosthetic aortic heart valve and ascending aorta.
You may qualify if:
- cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement
You may not qualify if:
- anticoagulation therapy intolerant
- active endocarditis
- anatomical or medical, surgical, psychological or social contraindications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35294, United States
University of Michigan
Ann Arbor, Michigan, 48104, United States
Mission Health & Hospitals
Asheville, North Carolina, 28801, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Klinik Floridsdorf
Vienna, 1012, Austria
Rigshospitalet
Copenhagen, 2100, Denmark
CHU de Besancon - Jean Minjoz
Besançon, 25030, France
CHRU Lille
Lille, 59037, France
Groupe Hospitalier Bichat - Claude Bernard
Paris, 75877, France
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen, 32545, Germany
Deutsches Herzzentrum Berlin
Berlin, 13353, Germany
Klinikum Links der Weser
Bremen, 28277, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Onassis Cardiac Surgery Center
Athens, 17674, Greece
Policlinico S.Orsola-Malpighi
Bologna, 40138, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Policlinico San Donato
San Donato Milanese, 20097, Italy
Wojewodzki Szpital Zespolony w Kielcach
Kielce, 25-736, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, 31-202, Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, 92-213, Poland
The Cardinal Stefan Wyszynski Institute of Cardiology
Warsaw, 04-628, Poland
Hospital Universitario del Vinalopó
Elche, 03293, Spain
Hospital Universitario Son Espases
Palma de Mallorca, 07120, Spain
James Cook University Hospital
Middlesbrough, TS43BW, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2021
First Posted
February 15, 2021
Study Start
July 13, 2021
Primary Completion (Estimated)
July 1, 2029
Study Completion (Estimated)
September 1, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04