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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Ultra Conservative ICD Programming
* Other: Traditional ICD Programming


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first ICD shock 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 | Number of ATP occurrences | Within 12 months following LVAD implant | 
| Frequency of ICD generator change prior to definitive therapy | Number of patients requiring ICD generator change | Within 12 months following LVAD implant | 
| Cardiac implantable electronic device (CIED) battery voltage/estimated longevity changes | Battery voltage and battery life measured in days | Within 12 months following LVAD implant | 
| Frequency of arrhythmic syncope | Number of syncope occurrences | Within 12 months following LVAD implant | 
| Hospitalization frequency for decompensated congestive heart failure | Number of hospitalizations | Within 12 months following LVAD implant | 
| Determine survival to heart transplantation 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Advanced Heart Failure, LVAD, Left Ventricular Assist Device, Heart-Assist Devices