At a glance
ClinicalIndex Comparison RecordN/ACompleted· 297 enrolled
Drug / intervention
Biocor and Biocor Supra valvesdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves
In Brief
A clinical study evaluating Biocor and Biocor Supra valves for Aortic Valve Insufficiency and 7 related conditions. Completed, enrolled 297 participants across 17 sites.
Detailed Summary
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence, Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Stenosis, Mitral Valve Incompetence
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2007
First PostedMar 2008
Primary CompletionOct 2015
Study CompletionMar 2016
TodayJul 2026
First PostedMar 17, 2008
Enrollment StartApr 1, 2007
Primary CompletionOct 1, 2015
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 18.3 years ago
Interventions
Biocor and Biocor Supra valvesdevice
Replacement for a diseased, damaged, malformed aortic or mitral heart valve