Trial Outcomes & Findings for Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra (NCT NCT00636987)

NCT ID: NCT00636987

Last Updated: 2019-02-04

Results Overview

Number of participants with Adverse Events

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 297 participants
• Primary outcome timeframe: 5 Years
• Results posted on: 2019-02-04

Participant Flow

Participant milestones

Measure	Implanted With Biocor or Biocor Supra Valves Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Overall Study STARTED	297
Overall Study COMPLETED	108
Overall Study NOT COMPLETED	189

Reasons for withdrawal

Measure	Implanted With Biocor or Biocor Supra Valves Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Overall Study Death	44
Overall Study Explanted	13
Overall Study Lost to Follow-up	63
Overall Study 5 year visit window not complete	69

Baseline Characteristics

Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

Baseline characteristics by cohort

Measure	Implanted With Biocor or Biocor Supra Valves n=297 Participants Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Age, Continuous	72.2 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants
Sex: Female, Male Male	174 Participants n=5 Participants
Region of Enrollment United States	297 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 Years

Number of participants with Adverse Events

Outcome measures

Measure	Implanted With Biocor, Biocor Supra, Biocor Mitral Valves n=297 Participants Biocor (aortic), Biocor Supra (aortic) and Biocor Mitral valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve	Biocor Supra Valve	Biocor Mitral Valve
Number of Participants With Adverse Events Structural Deterioration	3 participants	—	—
Number of Participants With Adverse Events Mortality-valve related	6 participants	—	—
Number of Participants With Adverse Events Mortality-cardiac related	14 participants	—	—
Number of Participants With Adverse Events Bleed	53 participants	—	—
Number of Participants With Adverse Events Embolism	10 participants	—	—
Number of Participants With Adverse Events Endocarditis	10 participants	—	—
Number of Participants With Adverse Events Reoperation-explant	13 participants	—	—
Number of Participants With Adverse Events Thrombosis	1 participants	—	—

PRIMARY outcome

Timeframe: 5 year

Population: Number of participants that completed the visit and assessment

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.

Outcome measures

Measure	Implanted With Biocor, Biocor Supra, Biocor Mitral Valves n=106 Participants Biocor (aortic), Biocor Supra (aortic) and Biocor Mitral valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve	Biocor Supra Valve	Biocor Mitral Valve
Characterize Patient NYHA Functional Classification Status NYHA I	73 participants	—	—
Characterize Patient NYHA Functional Classification Status NYHA II	24 participants	—	—
Characterize Patient NYHA Functional Classification Status NYHA III	9 participants	—	—
Characterize Patient NYHA Functional Classification Status NYHA IV	0 participants	—	—

PRIMARY outcome

Timeframe: 5 Year

Population: Number of participants that completed the visit and assessment

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.

Outcome measures

Measure	Implanted With Biocor, Biocor Supra, Biocor Mitral Valves n=43 Participants Biocor (aortic), Biocor Supra (aortic) and Biocor Mitral valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve	Biocor Supra Valve n=30 Participants	Biocor Mitral Valve n=17 Participants
Characterize the Hemodynamic Performance of the Valve 19mm	NA mmHg Standard Deviation NA no subjects implanted with this size valve followed through 5 years	17.8 mmHg Standard Deviation 7.8	NA mmHg Standard Deviation NA no subjects implanted with this size valve followed through 5 years
Characterize the Hemodynamic Performance of the Valve 21mm	20.5 mmHg Standard Deviation 8.1	12.7 mmHg Standard Deviation 5.9	NA mmHg Standard Deviation NA no subjects implanted with this size valve followed through 5 years
Characterize the Hemodynamic Performance of the Valve 23mm	16.7 mmHg Standard Deviation 6.3	15.1 mmHg Standard Deviation 4.9	NA mmHg Standard Deviation NA no subjects implanted with this size valve followed through 5 years
Characterize the Hemodynamic Performance of the Valve 25mm	11.3 mmHg Standard Deviation 5.5	9.0 mmHg Standard Deviation 2.3	NA mmHg Standard Deviation NA no subjects implanted with this size valve followed through 5 years
Characterize the Hemodynamic Performance of the Valve 27mm	14.4 mmHg Standard Deviation 4	5.6 mmHg Standard Deviation 0	4.2 mmHg Standard Deviation 0.6
Characterize the Hemodynamic Performance of the Valve 29mm	11.3 mmHg Standard Deviation 7.3	NA mmHg Standard Deviation NA no subjects implanted with this size valve followed through 5 years	3.7 mmHg Standard Deviation 2.3
Characterize the Hemodynamic Performance of the Valve 31mm	NA mmHg Standard Deviation NA no subjects implanted with this size valve followed through 5 years	NA mmHg Standard Deviation NA no subjects implanted with this size valve followed through 5 years	1.9 mmHg Standard Deviation 0.7
Characterize the Hemodynamic Performance of the Valve 33mm	NA mmHg Standard Deviation NA no subjects implanted with this size valve followed through 5 years	NA mmHg Standard Deviation NA no subjects implanted with this size valve followed through 5 years	2.0 mmHg Standard Deviation 0.8

Adverse Events

Implanted With Biocor or Biocor Supra Valves

Serious events: 91 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Implanted With Biocor or Biocor Supra Valves n=297 participants at risk Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve
Vascular disorders Major Bleed	16.8% 50/297
Vascular disorders Minor Bleed	1.3% 4/297
Nervous system disorders Embolism	3.4% 10/297
Cardiac disorders Endocarditis	3.4% 10/297
Surgical and medical procedures Reoperation-Explant	4.4% 13/297
Cardiac disorders Structural Deterioration	1.0% 3/297
Cardiac disorders Thrombosis	0.34% 1/297

Other adverse events

Adverse event data not reported

Additional Information

Sr. Clinical Manager

St Jude Medical

Phone: 6517566803

Email: jjohnson101@sjm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER