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Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

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ClinicalTrials.gov Identifier: NCT00636987
Recruitment Status : Completed
First Posted : March 17, 2008
Results First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
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
Intervention Device: Biocor and Biocor Supra valves
Enrollment 297
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Implanted With Biocor or Biocor Supra Valves
Hide Arm/Group Description Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Period Title: Overall Study
Started 297
Completed 108
Not Completed 189
Reason Not Completed
Death             44
Explanted             13
Lost to Follow-up             63
5 year visit window not complete             69
Arm/Group Title Implanted With Biocor or Biocor Supra Valves
Hide Arm/Group Description Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Overall Number of Baseline Participants 297
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 297 participants
72.2  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 297 participants
Female
123
  41.4%
Male
174
  58.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 297 participants
297
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description Number of participants with Adverse Events
Time Frame 5 Years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Implanted With Biocor, Biocor Supra, Biocor Mitral Valves
Hide Arm/Group Description:
Biocor (aortic), Biocor Supra (aortic) and Biocor Mitral valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Overall Number of Participants Analyzed 297
Measure Type: Number
Unit of Measure: participants
Mortality-valve related 6
Mortality-cardiac related 14
Bleed 53
Embolism 10
Endocarditis 10
Reoperation-explant 13
Structural Deterioration 3
Thrombosis 1
2.Primary Outcome
Title Characterize Patient NYHA Functional Classification Status
Hide Description

The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.

Class I. Patients with cardiac disease but without resulting limitation of physical activity.

Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.

Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.

Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.

The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.

Time Frame 5 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants that completed the visit and assessment
Arm/Group Title Implanted With Biocor or Biocor Supra Valves
Hide Arm/Group Description:
Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: participants
NYHA I 73
NYHA II 24
NYHA III 9
NYHA IV 0
3.Primary Outcome
Title Characterize the Hemodynamic Performance of the Valve
Hide Description

Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.

Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.

Time Frame 5 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants that completed the visit and assessment
Arm/Group Title Biocor Valve Biocor Supra Valve Biocor Mitral Valve
Hide Arm/Group Description:
Biocor valves: Replacement for a diseased, damaged, malformed aortic heart valve
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 43 30 17
Mean (Standard Deviation)
Unit of Measure: mmHg
19mm NA [1]   (NA) 17.8  (7.8) NA [1]   (NA)
21mm 20.5  (8.1) 12.7  (5.9) NA [1]   (NA)
23mm 16.7  (6.3) 15.1  (4.9) NA [1]   (NA)
25mm 11.3  (5.5) 9.0  (2.3) NA [1]   (NA)
27mm 14.4  (4) 5.6  (0) 4.2  (0.6)
29mm 11.3  (7.3) NA [1]   (NA) 3.7  (2.3)
31mm NA [1]   (NA) NA [1]   (NA) 1.9  (0.7)
33mm NA [1]   (NA) NA [1]   (NA) 2.0  (0.8)
[1]
no subjects implanted with this size valve followed through 5 years
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Implanted With Biocor or Biocor Supra Valves
Hide Arm/Group Description Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
All-Cause Mortality
Implanted With Biocor or Biocor Supra Valves
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Implanted With Biocor or Biocor Supra Valves
Affected / at Risk (%)
Total   91/297 (30.64%) 
Cardiac disorders   
Endocarditis  10/297 (3.37%) 
Structural Deterioration  3/297 (1.01%) 
Thrombosis  1/297 (0.34%) 
Nervous system disorders   
Embolism  10/297 (3.37%) 
Surgical and medical procedures   
Reoperation-Explant  13/297 (4.38%) 
Vascular disorders   
Major Bleed  50/297 (16.84%) 
Minor Bleed  4/297 (1.35%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Implanted With Biocor or Biocor Supra Valves
Affected / at Risk (%)
Total   0/297 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Sr. Clinical Manager
Organization: St Jude Medical
Phone: 6517566803
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00636987     History of Changes
Other Study ID Numbers: 0505
First Submitted: March 10, 2008
First Posted: March 17, 2008
Results First Submitted: October 14, 2016
Results First Posted: June 2, 2017
Last Update Posted: June 2, 2017