Clinical trial NCT04754217: Valved Graft PMCF Study
Official title: Valved Graft Post-Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Disease
Ascending Aorta Abnormality
Aortic Dissection
Keywords: Aortic Root Replacement
Ascending Aorta Replacement
Valved Graft
CAVGJ
VAVGJ
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2021-02-15
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll male and female subjects who will be undergoing replacement of a native or prosthetic aortic heart valve and ascending aorta.

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


Eligibility criteria: 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

Primary outcomes:
measure: annualized event rate of all-cause mortality
timeFrame: 5 Years
measure: annualized event rate of reintervention
timeFrame: 5 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Hospital - Univ. of Alabama at Birmingham (UAB)
state: Alabama
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Asheville
country: United States
facility: Mission Health & Hospitals
state: North Carolina
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Vienna
country: Austria
facility: Klinik Floridsdorf
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Besançon
country: France
facility: CHU de Besancon - Jean Minjoz
city: Lille
country: France
facility: CHRU Lille
city: Paris
country: France
facility: Groupe Hospitalier Bichat - Claude Bernard
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabetes Zentrum NRW
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Bremen
country: Germany
facility: Klinikum Links der Weser
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Center
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
city: Kielce
country: Poland
facility: Wojewodzki Szpital Zespolony w Kielcach
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II
city: Warsaw
country: Poland
facility: The Cardinal Stefan Wyszynski Institute of Cardiology
city: Łódź
country: Poland
facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
city: Elche
country: Spain
facility: Hospital Universitario del Vinalopó
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
Study officials:
References: