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Attain Model 4196 Left Ventricular (LV) Lead

This study has been completed.
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00271544
First received: December 28, 2005
Last updated: September 24, 2009
Last verified: September 2009
Results First Received: April 30, 2009  
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total number of patients enrolled after meeting inclusion/exclusion criteria was 190. Total number of patients that received an implant attempt was 186. Total number of patients with a 4196 lead attempt was 177. Total number of patients successfully implanted with a 4196 lead was 170. Some data was not reported and deviations were recorded.

Reporting Groups
  Description
4196 Lead Subjects underwent Model 4196 left ventricular lead implant attempt

Participant Flow:   Overall Study
    4196 Lead  
STARTED     190 [1]
Implant Attempted     186 [2]
Model 4196 Lead Attempted     177 [3]
COMPLETED     170 [4]
NOT COMPLETED     20  
Subjects did not receive a 4196 lead                 7  
Model 4196 lead not attempted                 9  
Implant not attempted                 4  
[1] Total number of subjects enrolled.
[2] Total number of subjects completed baseline and underwent system implant attempt.
[3] Total number of subjects attempted Model 4196 lead.
[4] Total number subjects successfully implanted 4196 lead.



  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
4196 Lead Subjects underwent Model 4196 left ventricular lead implant attempt

Baseline Measures
    4196 Lead  
Number of Participants  
[units: participants]
  186  
Age [1]
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     57  
>=65 years     129  
Age [1]
[units: years]
Mean ± Standard Deviation
  69.1  ± 11.1  
Gender [1]
[units: participants]
 
Female     48  
Male     138  
Region of Enrollment  
[units: participants]
 
United States     143  
Canada     43  
New York Heart Association [2]
[units: Participants]
 
Class III     182  
Class IV     2  
Missing     2  
Race / Ethnicity [1]
[units: Participants]
 
American Indian or Alaska Native     1  
Asian     2  
Black or African American     10  
Columbian     1  
Hispanic or Latino     3  
Native Hawaiian or Pacific Islander     1  
Sri Lankan     1  
Subject chose not to provide     6  
White     161  
Intrinsic QRS Width [2]
[units: Milliseconds]
Mean ± Standard Deviation
  153.1  ± 24.1  
Left Ventricular Ejection Fraction [3]
[units: Percent]
Mean ± Standard Deviation
  24.2  ± 6.9  
[1] All subjects who underwent an implant attempt (186) were included in the study population analyses.
[2] All subjects who underwent an implant attempt (186) were included in the study population analyses. Some subjects did not report data or data was outside the criteria, this was captured as a protocol deviation.
[3] All subjects who underwent an implant attempt (186) were included in the study population analyses. Some subjects did not report data or data was outside the criteria, this was captured as a protocol deviation. Left ventricular ejection fraction is the fraction of blood pumped out of the left ventricle with each heartbeat. For this measurement, the fraction is presented as a percent.



  Outcome Measures
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1.  Primary:   Safety (Subjects Without a Model 4196 Lead Related Complication)   [ Time Frame: One Month ]

2.  Primary:   Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)   [ Time Frame: One Month ]

3.  Primary:   Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)   [ Time Frame: Three Months ]

4.  Secondary:   Subjects Successfully Implanted With Model 4196 Lead   [ Time Frame: Implant ]

5.  Secondary:   Subjects Successfully Implanted After Cannulation   [ Time Frame: Implant ]

6.  Secondary:   All Left Ventricular Leads   [ Time Frame: Implant ]

7.  Secondary:   All Medtronic Left Ventricular Leads (Attain Family)   [ Time Frame: Implant ]

8.  Secondary:   Cannulation Time   [ Time Frame: Implant ]

9.  Secondary:   Fluoroscopy Time   [ Time Frame: Implant ]

10.  Secondary:   Model 4196 Lead Placement Time   [ Time Frame: Implant ]

11.  Secondary:   Total Implant Time   [ Time Frame: Implant ]

12.  Secondary:   Assessment of Lead Handling Characteristics   [ Time Frame: Implant ]

13.  Secondary:   Electrical Performance - Tip Electrode: Sensing   [ Time Frame: 12-month ]

14.  Secondary:   Electrical Performance - Tip Electrode: LV Voltage Threshold   [ Time Frame: 12-month ]

15.  Secondary:   Electrical Performance -Tip Electrode: Pacing Impedance   [ Time Frame: 12-month ]

16.  Secondary:   Electrical Performance -Ring Electrode: Sensing   [ Time Frame: Implant ]

17.  Secondary:   Electrical Performance - Ring Electrode: LV Voltage Threshold   [ Time Frame: 12-month ]

18.  Secondary:   Electrical Performance -Ring Electrode: Pacing Impedance   [ Time Frame: 12-Month ]

19.  Secondary:   Summarize All Adverse Events   [ Time Frame: Up to 18 months ]


  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
No text entered.


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Hang Nguyen
Organization: Medtronic CRDM Clinical Research
phone: 800-328-2518 ext 62832
e-mail: hang.t.nguyen@medtronic.com


No publications provided


Responsible Party: 4196 Clinical Trial Leader, Medtronic, Inc.
ClinicalTrials.gov Identifier: NCT00271544     History of Changes
Other Study ID Numbers: 241
Study First Received: December 28, 2005
Results First Received: April 30, 2009
Last Updated: September 24, 2009
Health Authority: United States: Food and Drug Administration