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Effect of Posture on Left Ventricular (LV) Transvenous Lead Capture Thresholds (EXPECT) (EXPECT)

This study has been terminated.
(Lower enrollment rate than expected)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01520714
First Posted: January 30, 2012
Last Update Posted: May 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Baylor Research Institute
February 22, 2010
January 30, 2012
August 9, 2013
May 26, 2014
May 26, 2014
December 2009
December 2011   (Final data collection date for primary outcome measure)
Evidence of Change in Threshold of >1 Volt With Posture Changes [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01520714 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Posture on Left Ventricular (LV) Transvenous Lead Capture Thresholds (EXPECT)
Effect of Posture on LV Transvenous Lead Capture Thresholds (EXPECT)
The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way.
Traditionally clinicians program the safety margins for the right atrial, right ventricular, and left ventricular leads two-times the capture thresholds. This safety margin is necessary for the right atrial and right ventricular outputs to prevent asystole during fluctuation of capture thresholds. This two-times safety margin may not be necessary for the left ventricular lead output and may be causing shorter device battery longevity. Newly implemented LV capture threshold management algorithms may help maintain a proper balance of safety margin and battery longevity. However, recent research conducted on automatic left ventricular capture measurement (LVCM) shows as much as 3.5 V daily variability in capture thresholds. In this same study, 18% of patients had >1.5 V LV threshold variability. A possible explanation for the variability of LV thresholds is lead stability. Small movements of the lead electrodes associated with movement of patient posture may account for daily fluctuation of capture thresholds. As heart failure patient care and therapies improve, CRT patients may survive longer than the projected longevities of their device. In order to minimize patient risks associated with device change-outs, care must be taken to maximize battery longevity while maintaining CRT pacing. Examining patient posture changes as a possible cause of threshold variability may guide clinicians to program more appropriate LV outputs with patient safety and device longevity in mind.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Congestive Heart Failure
Device: Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead
1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.
  • Experimental: Medtronic passive fixation LV lead
    Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule
    Intervention: Device: Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead
  • Experimental: Medtronic 4195 Active Fixation LV Lead
    Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule
    Intervention: Device: Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
December 2011
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Greater than 18 years of age and able to provide informed consent
  • Planned placement of a Medtronic LV pacing lead and a Medtronic ICD generator with LVCM technology
  • Geographically stable and able to follow-up for a period of at least six months post-procedure at The Heart Hospital Baylor Plano
  • Willingness to comply with the requirements of the protocol

Exclusion Criteria:

  • Life expectancy of less than six months
  • Plans for or significant possibility of pregnancy during the required follow-up window
  • Significant cardiovascular surgery planned within six months following ICD implant
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01520714
009-067
No
Not Provided
Not Provided
Baylor Research Institute
Baylor Research Institute
Medtronic
Principal Investigator: James B DeVille, M.D. Baylor Research Institute - The Heart Hospital Baylor Plano
Baylor Research Institute
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP