RecruitingNot Applicable

Valved Graft PMCF Study

United States260 participantsStarted 2021-07-13

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

annualized event rate of all-cause mortality

Timeframe: 5 Years

annualized event rate of reintervention

Timeframe: 5 Years

Trial details

NCT IDNCT04754217

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-07

Contact for this trial

Paolo Amato

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

View on ClinicalTrials.gov More Aortic Valve Disease trials