N/A
Completed 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
Source: ClinicalTrials.gov NCT00636987 ↗
Enrolled (actual)
297
Serious AEs
30.6%
Results posted
Jun 2017
Primary outcomePrimary: Number of Participants With Adverse Events — 6; 14; 53; 10 participants
Summary
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
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 | — |
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. Informational only — not medical advice.