NCT04754217RecruitingNot Applicable
Valved Graft Post-Market Clinical Follow-up Study
Abbott Medical Devices48 sites in 10 countries260 target enrollmentStarted: July 13, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Abbott Medical Devices
- Enrollment
- 260
- Locations
- 48
- Primary Endpoint
- annualized event rate of all-cause mortality
Study Overview
Brief Summary
Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 2
CAVGJ
Intervention: CAVGJ (Device)
Group 1
VAVGJ
Intervention: VAVGJ (Device)
Outcomes
Primary Outcomes
annualized event rate of all-cause mortality
Time Frame: 5 Years
Primary Safety Endpoint
annualized event rate of reintervention
Time Frame: 5 Years
Primary Effectiveness Endpoint
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (48)
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