Valved Graft PMCF Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Abbott Medical Devices
Study ID
NCT04754217
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Dissection
  • Aortic Valve Disease
  • Ascending Aorta Abnormality

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VAVGJ — DEVICE
    Replacement of the aortic valve and ascending aorta
  • CAVGJ — DEVICE
    Replacement of the aortic valve and ascending aorta

Study Details

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

Key Dates

Start date
Jul 13, 2021
Status verified
Apr 2026
Primary completion
Jul 31, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
260 participants (estimated)

Arms

  • Arm: Group 1
    VAVGJ
  • Arm: Group 2
    CAVGJ

Primary Outcome Measure

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

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University Hospital - Univ. of Alabama at Birmingham (UAB)BirminghamAlabama35294-
University of MichiganAnn ArborMichigan48104-
Mission Health & HospitalsAshevilleNorth Carolina28801-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-

Find similar trials in Birmingham, AL

By research site
University Hospital - Univ. of Alabama at Birmingham (UAB)· Birmingham, ALUniversity of Michigan· Ann Arbor, MIMission Health & Hospitals· Asheville, NCHospital of the University of Pennsylvania· Philadelphia, PAUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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