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

NCT ID: NCT01576562

Last Updated: 2017-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group - Control Group

VAD implantation (study group) or other cardiothoracic surgery (control group)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jordana Kron, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29766894 (View on PubMed)

Other Identifiers

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HM13674

Identifier Type: -

Identifier Source: org_study_id

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