Status:
COMPLETED
POWER (Pulse Width Optimized Waveform Evaluation Trial)
Lead Sponsor:
Abbott Medical Devices
Conditions:
Sudden Cardiac Death
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 defibrill...
Detailed Description
Sudden cardiac death (SCD) continues to be a significant cause of cardiac mortality with annual deaths ranging from 250,000 to 400,000 in the United States. Accordingly, implantable cardioverter-defib...
Eligibility Criteria
Inclusion
- 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
- Patient has a mechanical valve in the tricuspid position.
- Patient has epicardial defibrillation electrodes.
- Patient is pregnant.
- Patient is less than 18 years old.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT00311181
Start Date
August 1 2006
End Date
April 1 2008
Last Update
February 20 2019
Active Locations (2)
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1
Baptist Medical Center Montclair
Birmingham, Alabama, United States, 35212
2
Pacific Heart Institute
Santa Monica, California, United States, 90404