Trial Outcomes & Findings for POWER (Pulse Width Optimized Waveform Evaluation Trial) (NCT NCT00311181)
NCT ID: NCT00311181
Last Updated: 2019-02-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
217 participants
Primary outcome timeframe
Implant
Results posted on
2019-02-20
Participant Flow
Participant milestones
| Measure |
Group 1
|
|---|---|
|
Overall Study
STARTED
|
217
|
|
Overall Study
COMPLETED
|
121
|
|
Overall Study
NOT COMPLETED
|
96
|
Reasons for withdrawal
| Measure |
Group 1
|
|---|---|
|
Overall Study
Final DFTs were not obtained
|
96
|
Baseline Characteristics
POWER (Pulse Width Optimized Waveform Evaluation Trial)
Baseline characteristics by cohort
| Measure |
Group 1
n=217 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
88 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
129 Participants
n=5 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
217 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: ImplantOutcome measures
| Measure |
Group 1
n=121 Participants
|
|---|---|
|
Defibrillation Thresholds (DFTs) (3.5 ms Waveform)
|
427 Volts
Standard Error 11
|
PRIMARY outcome
Timeframe: ImplantOutcome measures
| Measure |
Group 1
n=121 Participants
|
|---|---|
|
DFT (2.5 ms Waveform)
|
454 Volts
Standard Error 11
|
PRIMARY outcome
Timeframe: ImplantOutcome measures
| Measure |
Group 1
n=121 Participants
|
|---|---|
|
DFT (4.5 ms Waveform)
|
435 Volts
Standard Error 11
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place