N/A
N=1,022
Aortic Valve Replacement With Trifecta(TM)
Aortic Valve Insufficiency · Regurgitation, Aortic Valve · Aortic Valve Incompetence · Aortic Valve Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT00475709 ↗Enrolled (actual)
1,022
Serious AEs
14.5%
Results posted
Mar 2014
Primary outcome: Primary: Late Adverse Event Rates — 1.90; 0; 2.61; 0.12 percentage of events/late patient years
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trifecta Aortic Heart Valve (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Late Adverse Event Rates |
1.90; 0; 2.61; 0.12; 1.07; 0.0 | — |
| PRIMARY Characterize Patient NYHA Functional Classification Status. |
85.3; 13.5; 1.2; 0 | — |
| PRIMARY Characterize the Hemodynamic Performance of the Valve. |
10.7; 8.1; 7.2; 6.2; 4.8; 4.7 | — |
Summary
To confirm the clinical safety and effectiveness of the Trifecta valve.
Eligibility Criteria
Inclusion Criteria
- Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).
- Legal age.
- Signed informed consent prior to surgery.
- Willing to complete all follow-up requirements.
Exclusion Criteria
- Pregnant or nursing women.
- Have already had a valve replaced other than the aortic valve.
- Needs another valve replaced.
- Cannot return for required follow-up visits.
- Have active endocarditis.
- Acute preoperative neurological event (such as a stroke).
- Renal dialysis.
- History of substance abuse within one year, or a prison inmate.
- Participating in another study.
- Life expectancy less than two years.
Data sourced from ClinicalTrials.gov (NCT00475709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.