Trial Outcomes & Findings for Artificial Valve Endocarditis Reduction Trial (NCT NCT00590889)
NCT ID: NCT00590889
Last Updated: 2019-02-27
Results Overview
Patient response to treatment with the Silzone™ treated valve will be evaluated based upon the incidence of early and late PVE (prosthetic valve endocarditis) in the treatment group vs. the control group.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
807 participants
Primary outcome timeframe
1 year
Results posted on
2019-02-27
Participant Flow
Participant milestones
| Measure |
SJM Conventional
SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff
Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling
|
SJM Silzone
SJM Masters Series Mechanical Heart Valve with Silzone Coating
Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling
|
|---|---|---|
|
Overall Study
STARTED
|
404
|
403
|
|
Overall Study
COMPLETED
|
118
|
104
|
|
Overall Study
NOT COMPLETED
|
286
|
299
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Artificial Valve Endocarditis Reduction Trial
Baseline characteristics by cohort
| Measure |
SJM Conventional
n=404 Participants
SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff
Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling
|
SJM Silzone
n=403 Participants
SJM Masters Series Mechanical Heart Valve with Silzone Coating
Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling
|
Total
n=807 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
244 participants
n=5 Participants
|
218 participants
n=7 Participants
|
462 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
159 participants
n=5 Participants
|
185 participants
n=7 Participants
|
344 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
333 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
236 Participants
n=5 Participants
|
238 Participants
n=7 Participants
|
474 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: subjects randomized into the study
Patient response to treatment with the Silzone™ treated valve will be evaluated based upon the incidence of early and late PVE (prosthetic valve endocarditis) in the treatment group vs. the control group.
Outcome measures
| Measure |
SJM Conventional
n=404 Participants
SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff
Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling
|
SJM Silzone
n=403 Participants
SJM Masters Series Mechanical Heart Valve with Silzone Coating
Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling
|
|---|---|---|
|
Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves.
|
10 participants
|
9 participants
|
Adverse Events
Adverse Events for the Conventional Group
Serious events: 194 serious events
Other events: 124 other events
Deaths: 0 deaths
Adverse Events for the Silzone™ Group
Serious events: 261 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adverse Events for the Conventional Group
n=404 participants at risk
These patients received a conventional heart valve.
|
Adverse Events for the Silzone™ Group
n=403 participants at risk
These patients received the Silzone™ treated heart valve.
|
|---|---|---|
|
Cardiac disorders
Explant due to PV (para-valvular) leak
|
0.74%
3/404 • Number of events 3 • 12 years
|
4.0%
16/403 • Number of events 16 • 12 years
|
|
Cardiac disorders
All reported explants
|
2.7%
11/404 • Number of events 11 • 12 years
|
6.7%
27/403 • Number of events 27 • 12 years
|
|
Cardiac disorders
All reported explants/repairs
|
4.0%
16/404 • Number of events 16 • 12 years
|
8.2%
33/403 • Number of events 33 • 12 years
|
|
Cardiac disorders
Major PV (Para-Valvular) leak
|
1.7%
7/404 • Number of events 7 • 12 years
|
4.7%
19/403 • Number of events 19 • 12 years
|
|
Cardiac disorders
Stroke/RIND
|
6.7%
27/404 • Number of events 27 • 12 years
|
6.5%
26/403 • Number of events 26 • 12 years
|
|
Cardiac disorders
All Cause Mortality
|
32.2%
130/404 • Number of events 130 • 12 years
|
34.7%
140/403 • Number of events 140 • 12 years
|
Other adverse events
| Measure |
Adverse Events for the Conventional Group
n=404 participants at risk
These patients received a conventional heart valve.
|
Adverse Events for the Silzone™ Group
n=403 participants at risk
These patients received the Silzone™ treated heart valve.
|
|---|---|---|
|
Cardiac disorders
Confirmed TE
|
15.1%
61/404 • Number of events 61 • 12 years
|
14.6%
59/403 • Number of events 59 • 12 years
|
|
Cardiac disorders
Confirmed TE without TIA
|
8.7%
35/404 • Number of events 35 • 12 years
|
7.9%
32/403 • Number of events 32 • 12 years
|
|
Cardiac disorders
Confimred TE Stroke
|
4.5%
18/404 • Number of events 18 • 12 years
|
4.5%
18/403 • Number of events 18 • 12 years
|
|
Cardiac disorders
Endocarditis
|
2.5%
10/404 • Number of events 10 • 12 years
|
2.2%
9/403 • Number of events 9 • 12 years
|
Additional Information
Heidi Hinrichs, VP of Clinical Study Management, St. Jude Medical
St.Jude Medical
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place