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Real Time 3-Dimensional Echocardiography for Left Ventricular Lead Site Selection to Reduce Cardiac Resynchronization Therapy Non-Responder Rates (ENVISION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01278030
First received: January 12, 2011
Last updated: October 21, 2013
Last verified: October 2013
Results First Received: June 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Heart Failure
Intervention: Procedure: 3D echo-guided LV lead placement

  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
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
3D Echo-guided LV Lead Placement The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
Control Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.

Participant Flow:   Overall Study
    3D Echo-guided LV Lead Placement     Control  
STARTED     43     35  
COMPLETED     35     31  
NOT COMPLETED     8     4  
Withdrawal by Subject                 8                 4  



  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.
No text entered.

Reporting Groups
  Description
3D Echo-guided LV Lead Placement The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
Control Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
Total Total of all reporting groups

Baseline Measures
    3D Echo-guided LV Lead Placement     Control     Total  
Number of Participants  
[units: participants]
  43     35     78  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     18     13     31  
>=65 years     25     22     47  
Age  
[units: years]
Mean ± Standard Deviation
  67  ± 13     67  ± 11     67  ± 12  
Gender  
[units: participants]
     
Female     15     9     24  
Male     28     26     54  
Region of Enrollment  
[units: participants]
     
United States     43     35     78  



  Outcome Measures

1.  Primary:   Responder Rate   [ Time Frame: At 6 month follow-up ]


  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: John Gill
Organization: St. Jude Medical
phone: 818-493-2609
e-mail: jgill@sjm.com


No publications provided


Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01278030     History of Changes
Other Study ID Numbers: CRD 534
Study First Received: January 12, 2011
Results First Received: June 4, 2013
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board