Trial Outcomes & Findings for Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve (NCT NCT01514162)

Results Overview

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:\[(Number of late adverse events/sum of late patient years) x 100\]

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

245 participants

Primary outcome timeframe

5 years

Results posted on

2019-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Trifecta Valve Group Subjects implanted with a Trifecta valve.
Overall Study STARTED	245
Overall Study COMPLETED	160
Overall Study NOT COMPLETED	85

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trifecta Valve Group n=245 Participants Subjects implanted with a Trifecta valve.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants
Age, Categorical >=65 years	200 Participants n=5 Participants
Age, Continuous	72 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants
Sex: Female, Male Male	172 Participants n=5 Participants
Region of Enrollment United States	245 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

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:\[(Number of late adverse events/sum of late patient years) x 100\]

Outcome measures

Outcome measures
Measure	Trifecta Valve Group n=245 Participants Subjects implanted with a Trifecta valve.
Late Adverse Event Incidence Thromboembolism	7 event/100-patient years
Late Adverse Event Incidence Valve thrombosis	0 event/100-patient years
Late Adverse Event Incidence Nonstructural Dysfunction	0 event/100-patient years
Late Adverse Event Incidence Structural Deterioration	4 event/100-patient years
Late Adverse Event Incidence Mortality	9 event/100-patient years
Late Adverse Event Incidence Endocarditis	0 event/100-patient years

SECONDARY outcome

Timeframe: 5 years

Population: Number of participants analyzed is those subjects with a visit and completed 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

Outcome measures
Measure	Trifecta Valve Group n=189 Participants Subjects implanted with a Trifecta valve.
Characterize Patient NYHA Functional Classification Status NYHA I	171 participants
Characterize Patient NYHA Functional Classification Status NYHA II	16 participants
Characterize Patient NYHA Functional Classification Status NYHA III	2 participants
Characterize Patient NYHA Functional Classification Status NYHA IV	0 participants

SECONDARY outcome

Timeframe: 5 years

Population: Aortic valve mean gradient at 5 years for participants analyzed with a visit and completed 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. 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.

Outcome measures

Outcome measures
Measure	Trifecta Valve Group n=176 Participants Subjects implanted with a Trifecta valve.
Report the Hemodynamic Performance of the Valve 19mm	15.4 mmHg Standard Deviation 5.9
Report the Hemodynamic Performance of the Valve 21mm	10.4 mmHg Standard Deviation 5.6
Report the Hemodynamic Performance of the Valve 23mm	9.2 mmHg Standard Deviation 4.9
Report the Hemodynamic Performance of the Valve 25mm	7.9 mmHg Standard Deviation 3.7
Report the Hemodynamic Performance of the Valve 27mm	8.4 mmHg Standard Deviation 8.8
Report the Hemodynamic Performance of the Valve 29mm	6.1 mmHg Standard Deviation 2.3

Adverse Events

Trifecta Valve Group

Serious events: 39 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Trifecta Valve Group n=245 participants at risk Subjects implanted with a Trifecta valve.
Cardiac disorders Thromboembolism	3.7% 9/245 • Number of events 9
Cardiac disorders Valve thrombosis	0.00% 0/245
Vascular disorders Major bleed	9.8% 24/245 • Number of events 24
Cardiac disorders Nonstructural dysfunction	0.00% 0/245
Cardiac disorders Endocarditis	0.00% 0/245
Blood and lymphatic system disorders Clinically significant hemolysis	0.00% 0/245
Cardiac disorders Structural deterioration	1.6% 4/245 • Number of events 4
Surgical and medical procedures Reoperation	0.82% 2/245 • Number of events 2
Cardiac disorders Valve related mortality	0.00% 0/245

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Johnson

St Jude Medical

Phone: 6517566803

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER