NCT01977703

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

3.2 years

First QC Date

October 30, 2013

Last Update Submit

August 13, 2017

Conditions

Heart Failure

Keywords

Heart FailureAdvanced Heart FailureLVADLeft Ventricular Assist DeviceHeart-Assist Devices

Outcome Measures

Primary Outcomes (1)

  • Time to first ICD shock following LVAD implant

    Within 12 months following LVAD implant

Secondary Outcomes (6)

  • Frequency of anti-tachycardia pacing (ATP) therapy administration for appropriate or inappropriate arrhythmia detection

    Within 12 months following LVAD implant

  • Frequency of ICD generator change prior to definitive therapy

    Within 12 months following LVAD implant

  • Cardiac implantable electronic device (CIED) battery voltage/estimated longevity changes

    Within 12 months following LVAD implant

  • Frequency of arrhythmic syncope

    Within 12 months following LVAD implant

  • Hospitalization frequency for decompensated congestive heart failure

    Within 12 months following LVAD implant

  • +1 more secondary outcomes

Study Arms (2)

Traditional ICD Programming

ACTIVE COMPARATOR

ICD will be set to pre-LVAD settings post LVAD implant.

Other: Traditional ICD Programming

Ultra Conservative ICD Programming

EXPERIMENTAL

ICD will be set to ultra conservative settings post LVAD implant.

Other: Ultra Conservative ICD Programming

Interventions

Ultra Conservative ICD ProgrammingOTHER
Ultra Conservative ICD Programming
Traditional ICD ProgrammingOTHER
Traditional ICD Programming

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Richardson TD, Hale L, Arteaga C, Xu M, Keebler M, Schlendorf K, Danter M, Shah A, Lindenfeld J, Ellis CR. Prospective Randomized Evaluation of Implantable Cardioverter-Defibrillator Programming in Patients With a Left Ventricular Assist Device. J Am Heart Assoc. 2018 Feb 23;7(5):e007748. doi: 10.1161/JAHA.117.007748.

    PMID: 29475875DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Christopher Ellis, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 7, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 16, 2017

Record last verified: 2017-08

Locations

US(1)