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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01977703

Collaborator

Thoratec Corporation (Industry)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: Ultra Conservative ICD Programming Other: Traditional ICD Programming	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Traditional ICD Programming

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

Other: Traditional ICD Programming

Experimental: Ultra Conservative ICD Programming

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

Other: Ultra Conservative ICD Programming

Outcome Measures

Primary Outcome Measures

Time to first ICD shock following LVAD implant [Within 12 months following LVAD implant]

Secondary Outcome Measures

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 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 arrhythmic syncope [Within 12 months following LVAD implant]
Number of syncope 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion:

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

Exclusion:

-Age < 18

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Vanderbilt University Medical Center
Thoratec Corporation

Investigators

Principal Investigator: Christopher Ellis, MD, Vanderbilt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christopher Ellis, Assistant Professor, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT01977703

Other Study ID Numbers:

131336

First Posted:

Nov 7, 2013

Last Update Posted:

Aug 16, 2017

Last Verified:

Aug 1, 2017

Keywords provided by Christopher Ellis, Assistant Professor, Vanderbilt University Medical Center

Heart Failure

Advanced Heart Failure

LVAD

Left Ventricular Assist Device

Heart-Assist Devices

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Aug 16, 2017