Health TrialsbyHealthPanel

Valved Graft PMCF Study

ConditionsAortic Valve DiseaseAscending Aorta AbnormalityAortic Dissection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbott Medical Devices

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement

Disqualifiers

anticoagulation therapy intolerant

active endocarditis

anatomical or medical, surgical, psychological or social contraindications

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • VAVGJ

    Device

    Replacement of the aortic valve and ascending aorta

  • CAVGJ

    Device

    Replacement of the aortic valve and ascending aorta

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Group 11 intervention
Group B: Group 21 intervention

Trial outcomes

Primary outcomes

1

annualized event rate of all-cause mortality

Primary Safety Endpoint

Time frame
5 Years
2

annualized event rate of reintervention

Primary Effectiveness Endpoint

Time frame
5 Years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abbott Medical Devices

Lead sponsor

Source ClinicalTrials.gov
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