Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation
The purpose of this research study is to test the function of a subjects implantable cardioverter defibrillator (ICD) function throughout the duration of their heart surgery. ICD function can be altered during some types of heart surgery such as those when a pump (ventricular assist device - VAD) is implanted. The investigators would like to study the mechanism of device and ICD malfunction.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation|
- observational study to assess potential changes that may occur in the RV ICD lead function during LVAD implantation and what mechanism may cause those changes in RV ICD lead function [ Time Frame: RV ICD lead function will be measured throughout LVAD placement , at 1 week post LVAD placement, and 3 months post LVAD placement Description: ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Study Group - Control Group
VAD implantation (study group) or other cardiothoracic surgery (control group)
ICD function is typically measured prior to and after surgery. For the study, the investigators will measure ICD lead function multiple times throughout the surgery as well, to determine if and when device malfunction occurs. ICD lead function is measured noninvasively through a specialized computer the same way it is checked in the clinic. In addition, the investigators will test ICD function as they usually do following surgery.
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Jordana Kron, MD||Virginia Commonwealth University|