POWER (Pulse Width Optimized Waveform Evaluation Trial)
Phase 4 Study That Compares the DFT (Defibrillation Threshold) Efficacy of 3 Different Membrane Time Constant Based Biphasic Defibrillation Waveforms
1 other identifier
interventional
217
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2006
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2006
CompletedFirst Posted
Study publicly available on registry
April 5, 2006
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
August 30, 2012
CompletedFebruary 20, 2019
February 1, 2019
1.7 years
April 3, 2006
July 24, 2011
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Defibrillation Thresholds (DFTs) (3.5 ms Waveform)
Implant
DFT (2.5 ms Waveform)
Implant
DFT (4.5 ms Waveform)
Implant
Study Arms (1)
2.5/3.5/4.5 ms defibrillation waveform
EXPERIMENTALInterventions
Patients that are indicated for an ICD or CRT-D receive one of these devices.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient has a mechanical valve in the tricuspid position.
- Patient has epicardial defibrillation electrodes.
- Patient is pregnant.
- Patient is less than 18 years old.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Baptist Medical Center Montclair
Birmingham, Alabama, 35212, United States
Pacific Heart Institute
Santa Monica, California, 90404, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ashish Oza
- Organization
- St Jude Medical
Study Officials
- PRINCIPAL INVESTIGATOR
Shephal Doshi, MD
Pacific Heart Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2006
First Posted
April 5, 2006
Study Start
August 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
February 20, 2019
Results First Posted
August 30, 2012
Record last verified: 2019-02