Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation
1 other identifier
observational
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2012
CompletedFirst Posted
Study publicly available on registry
April 12, 2012
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedAugust 8, 2017
August 1, 2017
2.2 years
April 10, 2012
August 7, 2017
Conditions
Keywords
Outcome Measures
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
RV ICD lead function will be measured throughout LVAD placement , at 1 week post LVAD placement, and 3 months post LVAD placement Description:
Study Arms (1)
Study Group - Control Group
VAD implantation (study group) or other cardiothoracic surgery (control group)
Eligibility Criteria
Patients with wireless ICDs undergoing VAD implantation (study group) or other cardiothoracic surgery (control group) will be included.
You may qualify if:
- Patients ages 18 and older
- Have a wireless implantable cardioverter defibrillator (ICD) and are undergoing VAD implantation or other cardiothoracic surgery.
You may not qualify if:
- Patients who are pacemaker dependent
- children, human fetuses, neonates
- prisoners will not be included
- Pregnant women will not be included
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Related Publications (1)
Hu YL, Kasirajan V, Tang DG, Shah KB, Koneru JN, Grizzard JD, Ellenbogen KA, Kron J. Prospective Evaluation of Implantable Cardioverter-Defibrillator Lead Function During and After Left Ventricular Assist Device Implantation. JACC Clin Electrophysiol. 2016 Jun;2(3):343-354. doi: 10.1016/j.jacep.2016.01.008. Epub 2016 Mar 23.
PMID: 29766894DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jordana Kron, MD
Virginia Commonwealth University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2012
First Posted
April 12, 2012
Study Start
February 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
August 8, 2017
Record last verified: 2017-08