Recruiting

Valved Graft

Sponsor:

Abbott Medical Devices

Code:

NCT04754217

Conditions

Aortic Valve Disease

Ascending Aorta Abnormality

Aortic Dissection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VAVGJ

CAVGJ

Study Details

Brief summary:

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

Conditions

Aortic Valve Disease

Ascending Aorta Abnormality

Aortic Dissection

Study ID

NCT04754217

Start date

Jul 13, 2021

Status verified date

Apr, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

260 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

VAVGJ

Group 2

CAVGJ

Interventions

VAVGJ

Replacement of the aortic valve and ascending aorta

CAVGJ

Replacement of the aortic valve and ascending aorta

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Paolo Amato

+39 335 61 40 573paolo.amato@abbott.com

Karine Miquel

+32 479 60 01 07karine.miquel@abbott.com

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48104

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

More Information

Sponsor

Abbott Medical Devices

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Aortic Root Replacement
  • Ascending Aorta Replacement
  • Valved Graft
  • CAVGJ
  • VAVGJ

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abbott Medical Devices on 2026-04-13.