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'Effect of CRT on Defibrillation Threshold Estimates' Study

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.
ClinicalTrials.gov Identifier: NCT00626093
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : January 21, 2013
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):

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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

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.
No text entered.

Reporting Groups
  Description
Group 1 No text entered.

Baseline Measures
   Group 1 
Overall Participants Analyzed 
[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

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

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

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