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Recruiting NCT04754217

Valved Graft PMCF Study

— Observational Aortic Valve Disease Ascending Aorta Abnormality Aortic Dissection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VAVGJ, CAVGJ.
Who it may be relevant to
Registry conditions: Aortic Valve Disease, Ascending Aorta Abnormality, Aortic Dissection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Austria, Denmark, France, Germany +5
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Valved Graft Post-Market Clinical Follow-up Study

Overview

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

Interventions

  • Device VAVGJ
    Replacement of the aortic valve and ascending aorta
  • Device CAVGJ
    Replacement of the aortic valve and ascending aorta

Primary outcome measures

  • annualized event rate of all-cause mortality [Time frame: 5 Years]
  • annualized event rate of reintervention [Time frame: 5 Years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 5 centers
  • University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham
  • University of Michigan — Ann Arbor
  • Mission Health & Hospitals — Asheville
  • Hospital of the University of Pennsylvania — Philadelphia
  • University of Pittsburgh Medical Center — Pittsburgh
Germany · 4 centers
  • Herz-und Diabetes Zentrum NRW — Bad Oeynhausen
  • Deutsches Herzzentrum Berlin — Berlin
  • Klinikum Links der Weser — Bremen
  • Medizinische Hochschule Hannover — Hanover
Poland · 4 centers
  • Wojewodzki Szpital Zespolony w Kielcach — Kielce
  • Krakowski Szpital Specjalistyczny im. Jana Pawla II — Krakow
  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi — Lodz
  • The Cardinal Stefan Wyszynski Institute of Cardiology — Warsaw
France · 3 centers
  • CHU de Besancon - Jean Minjoz — Besançon
  • CHRU Lille — Lille
  • Groupe Hospitalier Bichat - Claude Bernard — Paris
Italy · 3 centers
  • Policlinico S.Orsola-Malpighi — Bologna
  • Ospedale San Raffaele — Milan
  • Policlinico San Donato — San Donato Milanese
Spain · 2 centers
  • Hospital Universitario del Vinalopó — Elche
  • Hospital Universitario Son Espases — Palma de Mallorca
Austria · 1 center
  • Klinik Floridsdorf — Vienna
Denmark · 1 center
  • Rigshospitalet — Copenhagen
Greece · 1 center
  • Onassis Cardiac Surgery Center — Athens
United Kingdom · 1 center
  • James Cook University Hospital — Middlesbrough

Identifiers

NCT: NCT04754217 · ABT-CIP-10386

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗