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POWER (Pulse Width Optimized Waveform Evaluation Trial)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00311181
First Posted: April 5, 2006
Last Update Posted: August 30, 2012
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.
Information provided by (Responsible Party):
St. Jude Medical
Results First Submitted: July 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Sudden Cardiac Death
Intervention: Device: Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group 1 No text entered.

Participant Flow:   Overall Study
    Group 1
STARTED   217 
COMPLETED   121 
NOT COMPLETED   96 
Final DFTs were not obtained                96 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Group 1 No text entered.

Baseline Measures
   Group 1 
Overall Participants Analyzed 
[Units: Participants]
 217 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   88 
>=65 years   129 
Age 
[Units: Years]
Mean (Standard Deviation)
 67  (14) 
Gender 
[Units: Participants]
 
Female   57 
Male   160 
Region of Enrollment 
[Units: Participants]
 
United States   217 


  Outcome Measures
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1.  Primary:   Defibrillation Thresholds (DFTs) (3.5 ms Waveform)   [ Time Frame: Implant ]

2.  Primary:   DFT (2.5 ms Waveform)   [ Time Frame: Implant ]

3.  Primary:   DFT (4.5 ms Waveform)   [ Time Frame: Implant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ashish Oza
Organization: St Jude Medical
phone: 818-493-3648
e-mail: aoza@sjm.com



Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00311181     History of Changes
Other Study ID Numbers: CRD 324
First Submitted: April 3, 2006
First Posted: April 5, 2006
Results First Submitted: July 24, 2011
Results First Posted: August 30, 2012
Last Update Posted: August 30, 2012