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Model 4396 Left Ventricular (LV) Lead Study (4396)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
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;   Intervention Model: Single Group Assignment;   Masking: None (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
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
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.
No text entered.

Reporting Groups
  Description
Model 4396 LV Lead Subjects underwent Model 4396 left ventricular lead implant attempt

Baseline Measures
   Model 4396 LV Lead 
Overall Participants Analyzed 
[Units: Participants]
 193 
Age [1] 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   62 
>=65 years   131 
[1] All subjects who underwent an implant attempt (193) were included in the study population analysis.
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 69.6  (10.8) 
[1] All subjects who underwent an implant attempt (193) were included in the study population analysis.
Gender [1] 
[Units: Participants]
 
Female   53 
Male   140 
[1] All subjects who underwent an implant attempt (193) were included in the study population analysis.
Region of Enrollment [1] 
[Units: Participants]
 
France   10 
United States   125 
Saudi Arabia   0 
Canada   47 
Australia   2 
Denmark   3 
Austria   6 
Italy   0 
[1] All subjects who underwent an implant attempt (193) were included in the study population analysis.
New York Heart Association [1] 
[Units: Participants]
 
Class III   192 
Class IV   1 
[1] All subjects who underwent an implant attempt (193) were included in the study population analysis
Race/Ethnicity [1] 
[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 
[1] All subjects who underwent an implant attempt (193) were included in the study population.
Intrinsic QRS Width [1] 
[Units: Milliseconds]
Mean (Standard Deviation)
 154.1  (24.9) 
[1] All subjects who underwent an implant attempt (193) were included in the study population analysis.
Left Ventricular Ejection Fraction (LVEF) [1] 
[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. 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
  Show All Outcome Measures

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



Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
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