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OpenTrials
Completed

NCT Number: NCT01576562

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ages 18 and older
  • Have a wireless implantable cardioverter defibrillator (ICD) and are undergoing VAD implantation or other cardiothoracic surgery.

Exclusion criteria

  • Patients who are pacemaker dependent
  • children, human fetuses, neonates
  • prisoners will not be included
  • Pregnant women will not be included

Treatment and study plan

Primary outcomes

  1. 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:

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 12, 2012
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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