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Valved Graft PMCF Study

NCT ID: NCT04754217

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-13

Study Completion Date

2029-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Aortic Valve Disease Ascending Aorta Abnormality Aortic Dissection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

VAVGJ

VAVGJ

Intervention Type DEVICE

Replacement of the aortic valve and ascending aorta

Group 2

CAVGJ

CAVGJ

Intervention Type DEVICE

Replacement of the aortic valve and ascending aorta

Interventions

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VAVGJ

Replacement of the aortic valve and ascending aorta

Intervention Type DEVICE

CAVGJ

Replacement of the aortic valve and ascending aorta

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

Site Status WITHDRAWN

University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Mission Health & Hospitals

Asheville, North Carolina, United States

Site Status WITHDRAWN

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Klinik Floridsdorf

Vienna, , Austria

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

CHU de Besancon - Jean Minjoz

Besançon, , France

Site Status RECRUITING

CHRU Lille

Lille, , France

Site Status RECRUITING

Groupe Hospitalier Bichat - Claude Bernard

Paris, , France

Site Status RECRUITING

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, , Germany

Site Status RECRUITING

Deutsches Herzzentrum Berlin

Berlin, , Germany

Site Status RECRUITING

Klinikum Links der Weser

Bremen, , Germany

Site Status RECRUITING

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status RECRUITING

Onassis Cardiac Surgery Center

Athens, , Greece

Site Status RECRUITING

Policlinico S.Orsola-Malpighi

Bologna, , Italy

Site Status RECRUITING

Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Policlinico San Donato

San Donato Milanese, , Italy

Site Status RECRUITING

Wojewodzki Szpital Zespolony w Kielcach

Kielce, , Poland

Site Status WITHDRAWN

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, , Poland

Site Status RECRUITING

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, , Poland

Site Status ACTIVE_NOT_RECRUITING

The Cardinal Stefan Wyszynski Institute of Cardiology

Warsaw, , Poland

Site Status RECRUITING

Hospital Universitario del Vinalopó

Elche, , Spain

Site Status RECRUITING

Hospital Universitario Son Espases

Palma de Mallorca, , Spain

Site Status RECRUITING

James Cook University Hospital

Middlesbrough, , United Kingdom

Site Status RECRUITING

Countries

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United States Austria Denmark France Germany Greece Italy Poland Spain United Kingdom

Central Contacts

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Paolo Amato

Role: CONTACT

[email protected]
+39 335 61 40 573

Karine Miquel

Role: CONTACT

[email protected]
+32 479 60 01 07

Other Identifiers

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ABT-CIP-10386

Identifier Type: -

Identifier Source: org_study_id

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