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Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

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ClinicalTrials.gov Identifier: NCT01514162
Recruitment Status : Completed
First Posted : January 20, 2012
Results First Posted : May 31, 2017
Last Update Posted : May 31, 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
Condition Heart Valve Diseases
Intervention Device: Trifecta valve
Enrollment 245

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trifecta Valve Group
Hide Arm/Group Description Subjects implanted with a Trifecta valve.
Period Title: Overall Study
Started 245
Completed 160
Not Completed 85
Arm/Group Title Trifecta Valve Group
Hide Arm/Group Description Subjects implanted with a Trifecta valve.
Overall Number of Baseline Participants 245
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants
<=18 years
0
   0.0%
Between 18 and 65 years
45
  18.4%
>=65 years
200
  81.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 245 participants
72  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants
Female
73
  29.8%
Male
172
  70.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 245 participants
245
1.Primary Outcome
Title Late Adverse Event Incidence
Hide Description

Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events.

Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]

Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trifecta Valve Group
Hide Arm/Group Description:
Subjects implanted with a Trifecta valve.
Overall Number of Participants Analyzed 245
Measure Type: Number
Unit of Measure: event/100-patient years
Thromboembolism 7
Valve thrombosis 0
Nonstructural Dysfunction 0
Structural Deterioration 4
Mortality 9
Endocarditis 0
2.Secondary 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 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed is those subjects with a visit and completed assessment
Arm/Group Title Trifecta Valve Group
Hide Arm/Group Description:
Subjects implanted with a Trifecta valve.
Overall Number of Participants Analyzed 189
Measure Type: Number
Unit of Measure: participants
NYHA I 171
NYHA II 16
NYHA III 2
NYHA IV 0
3.Secondary Outcome
Title Report 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.

Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size.

Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Aortic valve mean gradient at 5 years for participants analyzed with a visit and completed assessment
Arm/Group Title Trifecta Valve Group
Hide Arm/Group Description:
Subjects implanted with a Trifecta valve.
Overall Number of Participants Analyzed 176
Mean (Standard Deviation)
Unit of Measure: mmHg
19mm 15.4  (5.9)
21mm 10.4  (5.6)
23mm 9.2  (4.9)
25mm 7.9  (3.7)
27mm 8.4  (8.8)
29mm 6.1  (2.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trifecta Valve Group
Hide Arm/Group Description Subjects implanted with a Trifecta valve.
All-Cause Mortality
Trifecta Valve Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Trifecta Valve Group
Affected / at Risk (%) # Events
Total   39/245 (15.92%)    
Blood and lymphatic system disorders   
Clinically significant hemolysis   0/245 (0.00%)  0
Cardiac disorders   
Thromboembolism   9/245 (3.67%)  9
Valve thrombosis   0/245 (0.00%)  0
Nonstructural dysfunction   0/245 (0.00%)  0
Endocarditis   0/245 (0.00%)  0
Structural deterioration   4/245 (1.63%)  4
Valve related mortality   0/245 (0.00%)  0
Surgical and medical procedures   
Reoperation   2/245 (0.82%)  2
Vascular disorders   
Major bleed   24/245 (9.80%)  24
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Trifecta Valve Group
Affected / at Risk (%) # Events
Total   0/245 (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: Jennifer Johnson
Organization: St Jude Medical
Phone: 6517566803
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01514162     History of Changes
Other Study ID Numbers: 1003
First Submitted: January 17, 2012
First Posted: January 20, 2012
Results First Submitted: October 14, 2016
Results First Posted: May 31, 2017
Last Update Posted: May 31, 2017