Prospective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).

August 13, 2017 updated by: Christopher Ellis, Vanderbilt University Medical Center
We propose to study a strategy empirically applied for the past 6 months at a high volume LVAD center (Vanderbilt Heart and Vascular Institute). This utilizes an ultra conservative device programming strategy to maximize battery longevity, avoid inappropriate implantable cardioverter defibrillator (ICD) therapy, improve quality of life through reduction in overall shock burden, and potentially avoid unnecessary device generator changes prior to transplant. Avoiding CIED (cardiac implantable electronic device) change out device procedures prior to transplant is desirable.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • Age ≥ 18
  • Advanced Heart Failure
  • Scheduled for Heartmate II LVAD implant
  • With existing ICD

Exclusion:

-Age < 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional ICD Programming
ICD will be set to pre-LVAD settings post LVAD implant.
Other: Traditional ICD Programming
Experimental: Ultra Conservative ICD Programming
ICD will be set to ultra conservative settings post LVAD implant.
Other: Ultra Conservative ICD Programming

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first ICD shock following LVAD implant
Time Frame: Within 12 months following LVAD implant
Within 12 months following LVAD implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of anti-tachycardia pacing (ATP) therapy administration for appropriate or inappropriate arrhythmia detection
Time Frame: Within 12 months following LVAD implant
Number of ATP occurrences
Within 12 months following LVAD implant
Frequency of ICD generator change prior to definitive therapy
Time Frame: Within 12 months following LVAD implant
Number of patients requiring ICD generator change
Within 12 months following LVAD implant
Cardiac implantable electronic device (CIED) battery voltage/estimated longevity changes
Time Frame: Within 12 months following LVAD implant
Battery voltage and battery life measured in days
Within 12 months following LVAD implant
Frequency of arrhythmic syncope
Time Frame: Within 12 months following LVAD implant
Number of syncope occurrences
Within 12 months following LVAD implant
Hospitalization frequency for decompensated congestive heart failure
Time Frame: Within 12 months following LVAD implant
Number of hospitalizations
Within 12 months following LVAD implant
Determine survival to heart transplantation following LVAD implant
Time Frame: Within 12 months following LVAD implant
Number of patients, post LVAD implant, to receive heart transplant and number of survival days post implant
Within 12 months following LVAD implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

Thoratec Corporation

Investigators

  • Principal Investigator: Christopher Ellis, MD, Vanderbilt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (Estimate)

November 7, 2013

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 13, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131336

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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