Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

Abbott

Status: Completed

Conditions: Mitral Valve Regurgitation; Mitral Valve Insufficiency; Aortic Valve Stenosis; Aortic Valve Regurgitation; Mitral Valve Stenosis; Aortic Valve Insufficiency; Mitral Valve Incompetence; Aortic Valve Incompetence

Treatments: Device: Biocor and Biocor Supra valves

Study type: Interventional

Funder types: Industry

Identifiers

NCT00636987

0505

Details and patient eligibility

About

The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.

Full description

The clinical investigation is a multi-center, prospective, non-randomized, observational, FDA-required post-approval study designed to further evaluate the safety and effectiveness of the Biocor and Biocor Supra Valves.

Enrollment: 297 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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297 participants in 1 patient group

Implanted with Biocor or Biocor Supra Valves

Other group

Treatment:

Device: Biocor and Biocor Supra valves