Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation

Completed

• Conditions: Heart Failure

• Registration Number: NCT01576562
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-12
• Study Start: 2014-02
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	RV ICD lead function will be measured throughout LVAD placement , at 1 week post LVAD placement, and 3 months post LVAD placement Description:

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States