N/A
N=297
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
Aortic Valve Insufficiency · Aortic Valve Regurgitation · Aortic Valve Stenosis · Aortic Valve Incompetence · Mitral Valve Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT00636987 ↗Enrolled (actual)
297
Serious AEs
30.6%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants With Adverse Events — 6; 14; 53; 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biocor and Biocor Supra valves (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
6; 14; 53; 10; 10; 13 | — |
| PRIMARY Characterize Patient NYHA Functional Classification Status |
73; 24; 9; 0 | — |
| PRIMARY Characterize the Hemodynamic Performance of the Valve |
NA; 17.8; NA; 20.5; 12.7; NA | — |
Summary
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
Eligibility Criteria
Inclusion Criteria
- Requires aortic or mitral 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
- Already have had a valve replaced other than that for the scheduled replacement
- 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 is a prison inmate
- Participating in another study
- Had the Biocor or Biocor Supra valve implanted but then the device was explanted
- Life expectancy less than five years
Data sourced from ClinicalTrials.gov (NCT00636987). 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.