POWER (Pulse Width Optimized Waveform Evaluation Trial)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00311181|
Recruitment Status : Completed
First Posted : April 5, 2006
Results First Posted : August 30, 2012
Last Update Posted : August 30, 2012
|Condition or disease||Intervention/treatment||Phase|
|Sudden Cardiac Death||Device: Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)||Phase 4|
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-defibrillators (ICD's) have proven to be an important therapeutic option for patients susceptible to SCD. Successful therapy and generator longevity are greatly dependent on proper defibrillation threshold (DFT) determination.
All modern ICD's utilize a biphasic waveform for defibrillation. It has been clearly shown that biphasic waveforms reduce the energy required for internal defibrillation of the heart. However, there is no consensus on which pulse widths are best for defibrillation.
St. Jude Medical ICD's (implantable cardioverter defibrillators) have programmable pulse widths, which allow the physician multiple options in dealing with ICD patients. By implanting ICD's with programmable pulse widths, this study utilizes the Tissue RC Resistance/Capacitance) model to try to identify the optimal pulse widths.
To determine the efficacy of an optimal membrane time constant estimate for the "tuned" waveform, defibrillation testing must be performed. Upper limit of vulnerability (ULV) has been proposed as an alternative means of predicting the DFT and it has been shown that ULV guided DFT testing can achieve a defibrillation success rate of 95%.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||217 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Phase 4 Study That Compares the DFT (Defibrillation Threshold) Efficacy of 3 Different Membrane Time Constant Based Biphasic Defibrillation Waveforms|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
|Experimental: 2.5/3.5/4.5 ms defibrillation waveform||
Device: Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)
Patients that are indicated for an ICD or CRT-D receive one of these devices.
- Defibrillation Thresholds (DFTs) (3.5 ms Waveform) [ Time Frame: Implant ]
- DFT (2.5 ms Waveform) [ Time Frame: Implant ]
- DFT (4.5 ms Waveform) [ Time Frame: Implant ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311181
|United States, Alabama|
|Baptist Medical Center Montclair|
|Birmingham, Alabama, United States, 35212|
|United States, California|
|Pacific Heart Institute|
|Santa Monica, California, United States, 90404|
|Principal Investigator:||Shephal Doshi, MD||Pacific Heart Institute|