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'Effect of CRT on Defibrillation Threshold Estimates' Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00626093
First received: February 7, 2008
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
Results First Received: July 21, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sudden Cardiac Death
Intervention: Device: Cardiac Resynchronization Therapy - Defibrillator (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
Cardiac Resynchronization Therapy - Defibrillators (CRT-D) All patients enrolled were indicated for a CRT-D.

Participant Flow:   Overall Study
    Cardiac Resynchronization Therapy - Defibrillators (CRT-D)  
STARTED     77  
COMPLETED     54  
NOT COMPLETED     23  
Lost to Follow-up                 5  
Death                 1  
Physician Decision                 4  
Withdrawal by Subject                 6  
Protocol Violation                 1  
One of the required devices not implante                 6  



  Baseline Characteristics
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Reporting Groups
  Description
Group 1 No text entered.

Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
 		  77  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     25  
>=65 years     52  
Age  
[units: years]
Mean ± Standard Deviation 		  69.9  ± 11.2  
Gender  
[units: participants]
 		 
Female     23  
Male     54  
Region of Enrollment  
[units: participants]
 		 
United States     77  



  Outcome Measures
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1.  Primary:   Defibrillation Threshold Difference Obtained in Volts (V) Between Implant and 6 Months   [ Time Frame: Baseline and 6 months ]
  Show Outcome Measure 1

2.  Secondary:   Defibrillation Threshold Difference Obtained in Joules (J)   [ Time Frame: Baseline and 6 months ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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.


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


Publications of Results:


Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00626093     History of Changes
Other Study ID Numbers: CRD 388
Study First Received: February 7, 2008
Results First Received: July 21, 2011
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board