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'Effect of CRT on Defibrillation Threshold Estimates' Study

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 29, 2008
Last Update Posted: January 24, 2013
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 21, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
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)
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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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
Group 1 No text entered.

Baseline Measures
   Group 1 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   25 
>=65 years   52 
[Units: Years]
Mean (Standard Deviation)
 69.9  (11.2) 
[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 ]

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

  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

Publications of Results:

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00626093     History of Changes
Other Study ID Numbers: CRD 388
First Submitted: February 7, 2008
First Posted: February 29, 2008
Results First Submitted: July 21, 2011
Results First Posted: January 21, 2013
Last Update Posted: January 24, 2013