Valved Graft PMCF Study

Valved Graft Post-Market Clinical Follow-up Study

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Disease; Aortic Dissection; Ascending Aorta Abnormality
• Intervention / Treatment: Device: VAVGJ; Device: CAVGJ

• Study Type: Observational
• Enrollment (Estimated): 260

Contacts and Locations

• Study Contact: Name: Paolo Amato; Phone Number: +39 335 61 40 573; Email: paolo.amato@abbott.com
• Study Contact Backup: Name: Karine Miquel; Phone Number: +32 479 60 01 07; Email: karine.miquel@abbott.com

Study Locations

• Austria
  • Vienna, Austria, 1012
    • Recruiting
    • Klinik Floridsdorf
• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet
• France
  • Besançon, France, 25030
    • Recruiting
    • CHU de Besançon - Jean Minjoz
  • Lille, France, 59037
    • Recruiting
    • CHRU Lille
  • Paris, France, 75877
    • Recruiting
    • Groupe Hospitalier Bichat - Claude Bernard
• Germany
  • Bad Oeynhausen, Germany, 32545
    • Recruiting
    • Herz-und Diabetes Zentrum NRW
  • Berlin, Germany, 13353
    • Recruiting
    • Deutsches Herzzentrum Berlin
  • Bremen, Germany, 28277
    • Recruiting
    • Klinikum Links der Weser
  • Hanover, Germany, 30625
    • Recruiting
    • Medizinische Hochschule Hannover
• Greece
  • Athens, Greece, 17674
    • Recruiting
    • Onassis Cardiac Surgery Center
• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Policlinico S.Orsola-Malpighi
  • Milan, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele
  • San Donato Milanese, Italy, 20097
    • Recruiting
    • Policlinico San Donato
• Poland
  • Kielce, Poland, 25-736
    • Withdrawn
    • Wojewodzki Szpital Zespolony w Kielcach
  • Krakow, Poland, 31-202
    • Recruiting
    • Krakowski Szpital Specjalistyczny im. Jana Pawla II
  • Lodz, Poland, 92-213
    • Active, not recruiting
    • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
  • Warsaw, Poland, 04-628
    • Recruiting
    • The Cardinal Stefan Wyszynski Institute of Cardiology
• Spain
  • Elche, Spain, 03293
    • Recruiting
    • Hospital Universitario del Vinalopó
  • Palma de Mallorca, Spain, 07120
    • Recruiting
    • Hospital Universitario Son Espases
• United Kingdom
  • Middlesbrough, United Kingdom, TS43BW
    • Recruiting
    • James Cook University Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Withdrawn
      • University Hospital - Univ. of Alabama at Birmingham (UAB)
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Recruiting
      • University of Michigan
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Withdrawn
      • Mission Health & Hospitals
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; VAVGJ	Device: VAVGJ; Replacement of the aortic valve and ascending aorta
Group 2; CAVGJ	Device: CAVGJ; Replacement of the aortic valve and ascending aorta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
annualized event rate of all-cause mortality	Primary Safety Endpoint	5 Years
annualized event rate of reintervention	Primary Effectiveness Endpoint	5 Years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Aortic Root Replacement; Ascending Aorta Replacement; Valved Graft; CAVGJ; VAVGJ
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Diseases; Aneurysm; Aortic Valve Disease; Aortic Dissection
• Other Study ID Numbers: ABT-CIP-10386

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No