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POWER (Pulse Width Optimized Waveform Evaluation Trial)
This study has been completed.
First Received: April 3, 2006   Last Updated: April 17, 2009   History of Changes
Sponsored by: St. Jude Medical
Information provided by: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00311181
  Purpose

The objective of this study is to compare the ULV/DFT 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.


Condition Intervention Phase
Sudden Cardiac Death
Device: ICD, CRT-D
Phase IV

MedlinePlus related topics: Cardiac Arrest
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Efficacy Study
Official Title: Phase 4 Study That Compares the DFT Efficacy of 3 Different Membrane Time Constant Based Biphasic Defibrillation Waveforms

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Difference between the defibrillation threshold estimates (voltage & energy) for 2.5, 3.5 and 4.5 ms membrane time constant based biphasic defibrillation waveforms

Secondary Outcome Measures:
  • NYHA Class
  • High Voltage Impedance
  • QT Interval
  • Cardiac Dimension
  • Antiarrhythmic Drug Therapy

Estimated Enrollment: 120
Study Start Date: August 2006
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-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 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%.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311181

Locations
United States, Alabama
Baptist Medical Center Montclair
Birmingham, Alabama, United States, 35212
United States, California
Pacific Heart Institute
Santa Monica, California, United States, 90404
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Shephal Doshi, MD Pacific Heart Institute
  More Information

No publications provided

Study ID Numbers: CRD 324
Study First Received: April 3, 2006
Last Updated: April 17, 2009
ClinicalTrials.gov Identifier: NCT00311181     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Medical:
ICD
Defibrillation
ULV
Tuned

Study placed in the following topic categories:
Death
Heart Diseases
Death, Sudden
Heart Arrest
Death, Sudden, Cardiac

Additional relevant MeSH terms:
Death
Pathologic Processes
Heart Diseases
Death, Sudden
Cardiovascular Diseases
Heart Arrest
Death, Sudden, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009