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OpenTrials
Completed

NCT Number: NCT01977703

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion:

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

Exclusion:

-Age < 18

Treatment and study plan

Ultra Conservative ICD Programming

Other

Traditional ICD Programming

Other

Primary outcomes

  1. Time to first ICD shock following LVAD implant

    Time frame: Within 12 months following LVAD implant

Secondary outcomes

  1. 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

  2. Frequency of ICD generator change prior to definitive therapy

    Time frame: Within 12 months following LVAD implant

    Number of patients requiring ICD generator change

  3. 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

  4. Frequency of arrhythmic syncope

    Time frame: Within 12 months following LVAD implant

    Number of syncope occurrences

  5. Hospitalization frequency for decompensated congestive heart failure

    Time frame: Within 12 months following LVAD implant

    Number of hospitalizations

  6. 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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Thoratec Corporation

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 7, 2013
Registry last updated
Aug 16, 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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