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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Ultra Conservative ICD Programming; Other: Traditional ICD Programming

• Registration Number: NCT01977703
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-07
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-13
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultra Conservative ICD Programming	Ultra Conservative ICD Programming	ICD will be set to ultra conservative settings post LVAD implant.
Traditional ICD Programming	Traditional ICD Programming	ICD will be set to pre-LVAD settings post LVAD implant.

Primary Outcome Measures

Name	Time	Method
Time to first ICD shock following LVAD implant	Within 12 months following LVAD implant

Secondary Outcome Measures

Name	Time	Method
Frequency of ICD generator change prior to definitive therapy	Within 12 months following LVAD implant	Number of patients requiring ICD generator change
Hospitalization frequency for decompensated congestive heart failure	Within 12 months following LVAD implant	Number of hospitalizations
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
Frequency of arrhythmic syncope	Within 12 months following LVAD implant	Number of syncope occurrences
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

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States