Model 4396 Left Ventricular (LV) Lead Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00853593
First received: February 26, 2009
Last updated: February 1, 2012
Last verified: February 2012
Results First Received: August 25, 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: Pacing 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
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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
  Description
Model 4396 LV Lead Subjects successfully implanted with a Model 4396 LV lead.

Participant Flow:   Overall Study
    Model 4396 LV Lead  
STARTED     197  
Implant Attempted     193  
Model 4396 Lead Attempted     164  
COMPLETED     152  
NOT COMPLETED     45  
Subjects did not receive a 4396 lead                 12  
Model 4396 lead not attempted                 29  
Implant not attempted                 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.
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Reporting Groups
  Description
Model 4396 LV Lead Subjects underwent Model 4396 left ventricular lead implant attempt

Baseline Measures
    Model 4396 LV Lead  
Number of Participants  
[units: participants]
  193  
Age [1]
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     62  
>=65 years     131  
Age [1]
[units: years]
Mean ± Standard Deviation
  69.6  ± 10.8  
Gender [1]
[units: participants]
 
Female     53  
Male     140  
Region of Enrollment [1]
[units: participants]
 
France     10  
United States     125  
Saudi Arabia     0  
Canada     47  
Australia     2  
Denmark     3  
Austria     6  
Italy     0  
New York Heart Association [2]
[units: participants]
 
Class III     192  
Class IV     1  
Race/Ethnicity [3]
[units: participants]
 
Asian     2  
Black or African American     9  
Hispanic or Latino     6  
Native Hawaiian or Pacific Islander     1  
White/Caucasian     168  
Subject chose not to provide information     6  
Other     1  
Intrinsic QRS Width [1]
[units: Milliseconds]
Mean ± Standard Deviation
  154.1  ± 24.9  
Left Ventricular Ejection Fraction (LVEF) [4]
[units: Percent]
Mean ± Standard Deviation
  25.7  ± 6.5  
[1] All subjects who underwent an implant attempt (193) were included in the study population analysis.
[2] All subjects who underwent an implant attempt (193) were included in the study population analysis
[3] All subjects who underwent an implant attempt (193) were included in the study population.
[4] All subjects who underwent an implant attempt (193) were included in the study population analysis. Note, one subject did not have a LVEF within 365 days of baseline and a study deviation was reported for not meeting inclusion/exclusion criteria.



  Outcome Measures
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1.  Primary:   Safety (Subjects Without a Model 4396 Lead Related Complication)   [ Time Frame: One month ]

2.  Primary:   Efficacy: Distal Tip Electrode Voltage Threshold   [ Time Frame: One month ]

3.  Primary:   Efficacy: Proximal Ring Voltage Threshold   [ Time Frame: Three months ]

4.  Secondary:   Subjects Successfully Implanted With Model 4396 Lead   [ Time Frame: During implant procedure. ]

5.  Secondary:   Subjects Successfully Implanted With Any Transvenous LV Lead After Cannulation   [ Time Frame: During implant procedure. ]

6.  Secondary:   Subjects Successfully Implanted With Any Transvenous LV Lead   [ Time Frame: During implant procedure. ]

7.  Secondary:   Subjects Successfully Implanted With Any Medtronic Attain Family LV Lead   [ Time Frame: During implant procedure. ]

8.  Secondary:   Cannulation Time   [ Time Frame: During implant procedure. ]

9.  Secondary:   Fluoroscopy Time   [ Time Frame: During implant procedure. ]

10.  Secondary:   Model 4396 Lead Placement Time   [ Time Frame: During implant procedure. ]

11.  Secondary:   Total Operation Time   [ Time Frame: During implant procedure. ]

12.  Secondary:   Assessment of Lead Handling Characteristics Reported as Acceptable   [ Time Frame: During implant procedure. ]

13.  Secondary:   Efficacy: Bipolar Voltage Threshold   [ Time Frame: 1 month ]

14.  Secondary:   Characterize Model 4396 Electrical Performance- Tip Electrode: Voltage Threshold   [ Time Frame: 6 month ]

15.  Secondary:   Characterize Model 4396 Electrical Performance- Tip Electrode: Pacing Impedance   [ Time Frame: 6 month ]

16.  Secondary:   Characterize Model 4396 Electrical Performance- Tip Electrode: Sensing   [ Time Frame: 6 month ]

17.  Secondary:   Characterize Model 4396 Electrical Performance- Ring Electrode: Voltage Threshold   [ Time Frame: 6 month ]

18.  Secondary:   Characterize Model 4396 Electrical Performance- Ring Electrode: Pacing Impedance   [ Time Frame: 6 month ]

19.  Secondary:   Characterize Model 4396 Electrical Performance- Ring Electrode: Sensing   [ Time Frame: During implant procedure. ]

20.  Secondary:   Characterize Model 4396 Electrical Performance- Bipolar Configuration: Voltage Threshold   [ Time Frame: 6 month ]

21.  Secondary:   Characterize Model 4396 Electrical Performance- Bipolar Configuration: Pacing Impedance   [ Time Frame: 6 month ]

22.  Secondary:   Characterize Model 4396 Electrical Performance- Bipolar Configuration: Sensing   [ Time Frame: 6 month ]


  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: 4396 Clinical Research Specialist
Organization: Medtronic, Inc
phone: 800-328-2518 ext 62808
e-mail: medtronicCRMtrials@medtronic.com


No publications provided


Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00853593     History of Changes
Other Study ID Numbers: 116
Study First Received: February 26, 2009
Results First Received: August 25, 2011
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Italy: Ministry of Health
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)