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Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00763698
First received: September 29, 2008
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
Results First Received: July 26, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Heart Failure
Intervention: Device: QuickFlex Micro Model 1258T Left Heart Lead

  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
The study was conducted at 18 investigational centers located in the United States (US). The first patient was enrolled on October 30, 2008 and follow up was completed on May 31, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients were included in the study analysis with the exception of patients who underwent unsuccessful implantation of the 1258T lead system. These patients were followed for a period of 30 days and then were withdrawn from the study.

Reporting Groups
  Description
QuickFlex Micro 1258T Left Heart Lead All patients received a QuickFlex Micro 1258T left heart lead and were evaluated for freedom from left ventricular lead complications at 3 months. Left ventricular lead related complications is defined as any adverse event related to the left ventricular lead that requires an invasive intervention.

Participant Flow:   Overall Study
    QuickFlex Micro 1258T Left Heart Lead  
STARTED     86  
COMPLETED     76  
NOT COMPLETED     10  
Unsuccessful Implant                 5  
Death                 4  
Withdrawal by Subject                 1  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Freedom From Left Ventricular Lead-related Complications   [ Time Frame: 3 months ]
  Show Outcome Measure 1

2.  Primary:   Percentage of Successful Left Ventricular Lead Implants   [ Time Frame: 3 months ]
  Show Outcome Measure 2

3.  Primary:   Left Ventricular Bipolar Pacing Capture Threshold (Volts)   [ Time Frame: 3 months ]
  Show Outcome Measure 3


  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: Director, Clinical Affairs
Organization: St. Jude Medical
phone: (408) 522-6410
e-mail: tshipman@sjm.com


No publications provided


Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00763698     History of Changes
Other Study ID Numbers: CRD 435
Study First Received: September 29, 2008
Results First Received: July 26, 2011
Last Updated: September 28, 2011
Health Authority: United States: Food and Drug Administration