Status:
TERMINATED
Effect of Posture on Left Ventricular (LV) Transvenous Lead Capture Thresholds (EXPECT)
Lead Sponsor:
Baylor Research Institute
Collaborating Sponsors:
Medtronic
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether changes in a patient's position affect LV capture thresholds in a clinically significant way.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01520714
Start Date
December 1 2009
End Date
December 1 2011
Last Update
May 26 2014
Active Locations (1)
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1
The Heart Hospital in Plano
Plano, Texas, United States, 75093