Clinical trial NCT00636987: Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
Official title: Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Insufficiency
Aortic Valve Regurgitation
Aortic Valve Stenosis
Aortic Valve Incompetence
Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Stenosis
Mitral Valve Incompetence
Keywords: aortic valve
mitral valve
heart valve
tissue valve
bioprosthesis
valve disorder
valve disease
cardiac surgery
aortic valve regurgitation
aortic valve stenosis
mitral valve regurgitation
mitral valve stenosis
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-03-17
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 5 Years
measure: Characterize Patient NYHA Functional Classification Status
timeFrame: 5 year
measure: Characterize the Hemodynamic Performance of the Valve
timeFrame: 5 Year
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital/Scripps Clinic
state: California
city: Los Angeles
country: United States
facility: USC University Hospital, Department of Cardiothoracic Surgery
state: California
city: Evansville
country: United States
facility: The Heart Group, PC
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Heart Hospital
state: Indiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Saint Paul
country: United States
facility: HealthEast St. Joseph Hospital
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Saint Thomas Hospital
state: Tennessee
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital/Sentara Heart Hospital
state: Virginia
Study officials:
affiliation: Abbott Medical Devices
name: Urban Lonn, MD, PhD
role: STUDY_DIRECTOR
References: