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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01977703

Enrollment

Registered

2013-11-07

Start date

2013-10-31

Completion date

2016-12-31

Last updated

2017-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure, Advanced Heart Failure, LVAD, Left Ventricular Assist Device, Heart-Assist Devices

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.

Interventions

OTHERUltra Conservative ICD Programming

OTHERTraditional ICD Programming

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion: * Age ≥ 18 * Advanced Heart Failure * Scheduled for Heartmate II LVAD implant * With existing ICD Exclusion: -Age \< 18

Design outcomes

Primary

Measure	Time frame
Time to first ICD shock following LVAD implant	Within 12 months following LVAD implant

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026