Trial Outcomes & Findings for Aortic Valve Replacement With Trifecta(TM) (NCT NCT00475709)
NCT ID: NCT00475709
Last Updated: 2019-02-19
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:\[(Number of late adverse events/sum of late patient years) x 100\]
COMPLETED
NA
1022 participants
Events occurring greater than or equal to 31 days post-implant.
2019-02-19
Participant Flow
Participant milestones
| Measure |
Subjects Implanted With Trifecta Valve
All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
|
|---|---|
|
Overall Study
STARTED
|
1022
|
|
Overall Study
Eligible of Analysis
|
1014
|
|
Overall Study
COMPLETED
|
946
|
|
Overall Study
NOT COMPLETED
|
76
|
Reasons for withdrawal
| Measure |
Subjects Implanted With Trifecta Valve
All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
|
|---|---|
|
Overall Study
Did not meet eligibility criteria
|
8
|
|
Overall Study
Death
|
41
|
|
Overall Study
Device Explant
|
6
|
|
Overall Study
Lost to Follow-up
|
21
|
Baseline Characteristics
Aortic Valve Replacement With Trifecta(TM)
Baseline characteristics by cohort
| Measure |
Trifecta Aortic Heart Valve
n=1014 Participants
All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
|
|---|---|
|
Age, Continuous
|
72.5 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
364 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
650 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Events occurring greater than or equal to 31 days post-implant.Population: Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.
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
| Measure |
Trifecta Aortic Heart Valve
n=1014 Participants
All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
|
|---|---|
|
Late Adverse Event Rates
Thromboembolism
|
1.90 percentage of events/late patient years
|
|
Late Adverse Event Rates
Valve Thrombosis
|
0 percentage of events/late patient years
|
|
Late Adverse Event Rates
Major Bleed
|
2.61 percentage of events/late patient years
|
|
Late Adverse Event Rates
Mortality (All Cause)
|
2.72 percentage of events/late patient years
|
|
Late Adverse Event Rates
Nonstructural Dysfunction
|
0.12 percentage of events/late patient years
|
|
Late Adverse Event Rates
Endocarditis
|
1.07 percentage of events/late patient years
|
|
Late Adverse Event Rates
Clinically Significant Hemolysis
|
0.0 percentage of events/late patient years
|
|
Late Adverse Event Rates
Structural Deterioration
|
0.12 percentage of events/late patient years
|
|
Late Adverse Event Rates
Valve Reoperation
|
0.59 percentage of events/late patient years
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.
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 |
Trifecta Aortic Heart Valve
n=1014 Participants
All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
|
|---|---|
|
Characterize Patient NYHA Functional Classification Status.
NYHA III at 1 year
|
1.2 percentage of participants
|
|
Characterize Patient NYHA Functional Classification Status.
NYHA I at 1 year
|
85.3 percentage of participants
|
|
Characterize Patient NYHA Functional Classification Status.
NYHA II at 1 year
|
13.5 percentage of participants
|
|
Characterize Patient NYHA Functional Classification Status.
NYHA IV at 1 year
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.
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
| Measure |
Trifecta Aortic Heart Valve
n=1014 Participants
All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
|
|---|---|
|
Characterize the Hemodynamic Performance of the Valve.
19 mm Mean Gradient (1 year)
|
10.7 mm Hg
Standard Deviation 4.6
|
|
Characterize the Hemodynamic Performance of the Valve.
21 mm Mean Gradient (1 year)
|
8.1 mm Hg
Standard Deviation 3.5
|
|
Characterize the Hemodynamic Performance of the Valve.
23 mm Mean Gradient (1 year)
|
7.2 mm Hg
Standard Deviation 2.8
|
|
Characterize the Hemodynamic Performance of the Valve.
25 mm Mean Gradient (1 year)
|
6.2 mm Hg
Standard Deviation 2.7
|
|
Characterize the Hemodynamic Performance of the Valve.
27 mm Mean Gradient (1 year)
|
4.8 mm Hg
Standard Deviation 2.0
|
|
Characterize the Hemodynamic Performance of the Valve.
29 mm Mean Gradient (1 year)
|
4.7 mm Hg
Standard Deviation 1.6
|
Adverse Events
Subjects Implanted With Trifecta Valve
Serious adverse events
| Measure |
Subjects Implanted With Trifecta Valve
n=1014 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Clinically Significant Hemolysis
|
0.00%
0/1014
Early (adverse events occuring on or before 30 days post procedure) and Late(adverse events occurring greater than or equal to 31 days post procedure) are combined for the Valve Related Serious Adverse Event data analysis.
|
|
Cardiac disorders
Thromboembolism
|
3.9%
40/1014 • Number of events 43
Early (adverse events occuring on or before 30 days post procedure) and Late(adverse events occurring greater than or equal to 31 days post procedure) are combined for the Valve Related Serious Adverse Event data analysis.
|
|
Cardiac disorders
Valve Thrombosis
|
0.00%
0/1014
Early (adverse events occuring on or before 30 days post procedure) and Late(adverse events occurring greater than or equal to 31 days post procedure) are combined for the Valve Related Serious Adverse Event data analysis.
|
|
General disorders
Major Bleed
|
9.5%
96/1014 • Number of events 103
Early (adverse events occuring on or before 30 days post procedure) and Late(adverse events occurring greater than or equal to 31 days post procedure) are combined for the Valve Related Serious Adverse Event data analysis.
|
|
Cardiac disorders
Non-structural dysfunction
|
0.39%
4/1014 • Number of events 4
Early (adverse events occuring on or before 30 days post procedure) and Late(adverse events occurring greater than or equal to 31 days post procedure) are combined for the Valve Related Serious Adverse Event data analysis.
|
|
Infections and infestations
Endocarditis
|
0.89%
9/1014 • Number of events 9
Early (adverse events occuring on or before 30 days post procedure) and Late(adverse events occurring greater than or equal to 31 days post procedure) are combined for the Valve Related Serious Adverse Event data analysis.
|
|
Cardiac disorders
Structural deterioration
|
0.10%
1/1014 • Number of events 1
Early (adverse events occuring on or before 30 days post procedure) and Late(adverse events occurring greater than or equal to 31 days post procedure) are combined for the Valve Related Serious Adverse Event data analysis.
|
|
Surgical and medical procedures
Reoperation
|
0.59%
6/1014 • Number of events 6
Early (adverse events occuring on or before 30 days post procedure) and Late(adverse events occurring greater than or equal to 31 days post procedure) are combined for the Valve Related Serious Adverse Event data analysis.
|
|
Cardiac disorders
Valve related Mortality
|
0.49%
5/1014 • Number of events 5
Early (adverse events occuring on or before 30 days post procedure) and Late(adverse events occurring greater than or equal to 31 days post procedure) are combined for the Valve Related Serious Adverse Event data analysis.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER