Phase 4
N=217
POWER (Pulse Width Optimized Waveform Evaluation Trial)
Sudden Cardiac Death
Bottom Line
View on ClinicalTrials.gov: NCT00311181 ↗Enrolled (actual)
217
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Defibrillation Thresholds (DFTs) (3.5 ms Waveform) — 427 Volts
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Defibrillation Thresholds (DFTs) (3.5 ms Waveform) |
427 | — |
| PRIMARY DFT (2.5 ms Waveform) |
454 | — |
| PRIMARY DFT (4.5 ms Waveform) |
435 | — |
Summary
The objective of this study is to compare the ULV (Upper Limit of Vulnerability)/DFT (Defibrillation Threshold) efficacy between the 2.5, 3.5 and 4.5 ms membrane time constant based biphasic defibrillation waveforms. This comparison will result in identifying the optimal membrane time constant when programming the "tuned" defibrillation waveform.
Eligibility Criteria
Inclusion Criteria
- Patient is a candidate for ICD/CRT-D implantation.
- Patient has a compatible transvenous defibrillation lead system.
- Patient has had an echocardiogram, MUGA, or cath procedure within 6 months of ICD/CRT-D implant.
- Patient is able to tolerate ULV guided DFT testing.
Exclusion Criteria
- Patient has a mechanical valve in the tricuspid position.
- Patient has epicardial defibrillation electrodes.
- Patient is pregnant.
- Patient is less than 18 years old.
Data sourced from ClinicalTrials.gov (NCT00311181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.