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Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00746356
First received: September 2, 2008
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
Results First Received: July 24, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Heart Failure
Ventricular Arrythmias
Intervention: Device: Testing of the autocapture features of the device

  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
Recruitment began in August 2008 at hospitals where patients were being implanted with implantable cardioverter defibrillators or in and physician offices where these patients were being followed. Recruitment was completed on April 1, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients who were enrolled in the study had the autocapture feature tested at each study visit, starting with at the implant visit when the study device was implanted.

Reporting Groups
  Description
CRT-D Device Patients All patients with a cardiac resynchronization therapy device (CRT-D)enrolled in the study.
ICD Device Patients All patients with an implantable cardioverter defibrillator (ICD) device enrolled in the study.

Participant Flow:   Overall Study
    CRT-D Device Patients     ICD Device Patients  
STARTED     81     47  
COMPLETED     70     40  
NOT COMPLETED     11     7  
Withdrawal by Subject                 2                 3  
Death                 7                 3  
Lost to Follow-up                 1                 0  
Removal of Device                 0                 1  
Patient relocated                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
All Patients All patients enrolled in the study

Baseline Measures
    All Patients  
Number of Participants  
[units: participants]
 		  128  
Age  
[units: years]
Mean ± Standard Deviation 		  67  ± 12  
Gender  
[units: participants]
 		 
Female     32  
Male     96  
Cardiomyopathy  
[units: Participants]
 		 
Ischemic Etiology     87  
Non-Ischemic Etiology     41  



  Outcome Measures
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1.  Primary:   Percentage of Participants Free of System-related Complications at 3-months Post Implant   [ Time Frame: 3 months post implant ]
  Show Outcome Measure 1

2.  Primary:   Atrial AutoCapture (ACap) Confirm Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test   [ Time Frame: 3 months post implant ]
  Show Outcome Measure 2

3.  Primary:   Ventricular Autocapture Effectiveness Endpoint - Absolute Difference Between the Automatic and Manual Capture Threshold Test   [ Time Frame: 3 months post implant ]
  Show Outcome Measure 3

4.  Primary:   Right Ventricular (RV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test   [ Time Frame: 3 months post implant ]
  Show Outcome Measure 4

5.  Primary:   Left Ventricular (LV) AutoCapture Effectiveness Endpoint - Difference Between the Automatic and Manual Capture Threshold Test   [ Time Frame: 3 months post implant ]
  Show Outcome Measure 5


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
No text entered.  


Results Point of Contact:  
Name/Title: Ashish Oza, Clinical Studies Director
Organization: St. Jude Medical
phone: 818 362 6822 ext 3648
e-mail: aoza@sjm.com


No publications provided


Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00746356     History of Changes
Other Study ID Numbers: 40005027, IDE # G080060, Doc number 40005027
Study First Received: September 2, 2008
Results First Received: July 24, 2011
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration