Valved Graft PMCF Study

Recruiting

• Conditions: Aortic Dissection; Aortic Valve Disease; Ascending Aorta Abnormality
• Interventions: Device: VAVGJ; Device: CAVGJ

• Registration Number: NCT04754217
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-15
• Study Start: 2021-07-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2029-07
• Study Completion: 2029-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	VAVGJ	VAVGJ
Group 2	CAVGJ	CAVGJ

Primary Outcome Measures

Name	Time	Method
annualized event rate of all-cause mortality	5 Years	Primary Safety Endpoint
annualized event rate of reintervention	5 Years	Primary Effectiveness Endpoint

Trial Locations

Locations (25)

Hospital Universitario del Vinalopó; 🇪🇸 Elche, Spain

Policlinico S.Orsola-Malpighi; 🇮🇹 Bologna, Italy

Hospital Universitario Son Espases; 🇪🇸 Palma De Mallorca, Spain

Ospedale San Raffaele; 🇮🇹 Milan, Italy

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Klinik Floridsdorf; 🇦🇹 Vienna, Austria

The Cardinal Stefan Wyszynski Institute of Cardiology; 🇵🇱 Warsaw, Poland

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Wojewodzki Szpital Zespolony w Kielcach; 🇵🇱 Kielce, Poland

Onassis Cardiac Surgery Center; 🇬🇷 Athens, Greece

Herz-und Diabetes Zentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Klinikum Links der Weser; 🇩🇪 Bremen, Germany

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi; 🇵🇱 Łódź, Poland

CHRU Lille; 🇫🇷 Lille, France

Policlinico San Donato; 🇮🇹 San Donato Milanese, Italy

Groupe Hospitalier Bichat - Claude Bernard; 🇫🇷 Paris, France

Krakowski Szpital Specjalistyczny im. Jana Pawla II; 🇵🇱 Krakow, Poland

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

CHU de Besancon - Jean Minjoz; 🇫🇷 Besançon, France

James Cook University Hospital; 🇬🇧 Middlesbrough, United Kingdom

University Hospital - Univ. of Alabama at Birmingham (UAB); 🇺🇸 Birmingham, Alabama, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Mission Health & Hospitals; 🇺🇸 Asheville, North Carolina, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States