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

Vanderbilt University Medical Center

Status: Completed

Conditions: Heart Failure

Treatments: Other: Ultra Conservative ICD Programming; Other: Traditional ICD Programming

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01977703

131336

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

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

Exclusion:

-Age < 18

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Traditional ICD Programming

Active Comparator group

Description:

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

Treatment:

Other: Traditional ICD Programming

Ultra Conservative ICD Programming

Experimental group

Description:

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

Treatment:

Other: Ultra Conservative ICD Programming