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POWER (Pulse Width Optimized Waveform Evaluation Trial)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00311181
First received: April 3, 2006
Last updated: July 27, 2012
Last verified: July 2012
Results First Received: July 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   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  
Number of Participants  
[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


No publications provided


Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00311181     History of Changes
Other Study ID Numbers: CRD 324
Study First Received: April 3, 2006
Results First Received: July 24, 2011
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board