Back to resultsProspective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultra Conservative ICD Programming
Traditional ICD Programming
Sponsored by
About this trial
This is an interventional health services research trial for Heart Failure focused on measuring Heart Failure, Advanced Heart Failure, LVAD, Left Ventricular Assist Device, Heart-Assist Devices
Eligibility Criteria
Inclusion:
- Age ≥ 18
- Advanced Heart Failure
- Scheduled for Heartmate II LVAD implant
- With existing ICD
Exclusion:
-Age < 18
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional ICD Programming
Ultra Conservative ICD Programming
Arm Description
ICD will be set to pre-LVAD settings post LVAD implant.
ICD will be set to ultra conservative settings post LVAD implant.
Outcomes
Primary Outcome Measures
Time to first ICD shock following LVAD implant
Secondary Outcome Measures
Frequency of anti-tachycardia pacing (ATP) therapy administration for appropriate or inappropriate arrhythmia detection
Number of ATP occurrences
Frequency of ICD generator change prior to definitive therapy
Number of patients requiring ICD generator change
Cardiac implantable electronic device (CIED) battery voltage/estimated longevity changes
Battery voltage and battery life measured in days
Frequency of arrhythmic syncope
Number of syncope occurrences
Hospitalization frequency for decompensated congestive heart failure
Number of hospitalizations
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
Full Information
NCT ID
NCT01977703
First Posted
October 30, 2013
Last Updated
August 13, 2017
Sponsor
Vanderbilt University Medical Center
Collaborators
Thoratec Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01977703
Brief Title
Prospective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).
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 Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Thoratec Corporation
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Advanced Heart Failure, LVAD, Left Ventricular Assist Device, Heart-Assist Devices
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional ICD Programming
Arm Type
Active Comparator
Arm Description
ICD will be set to pre-LVAD settings post LVAD implant.
Arm Title
Ultra Conservative ICD Programming
Arm Type
Experimental
Arm Description
ICD will be set to ultra conservative settings post LVAD implant.
Intervention Type
Other
Intervention Name(s)
Ultra Conservative ICD Programming
Intervention Type
Other
Intervention Name(s)
Traditional ICD Programming
Primary Outcome Measure Information:
Title
Time to first ICD shock following LVAD implant
Time Frame
Within 12 months following LVAD implant
Secondary Outcome Measure Information:
Title
Frequency of anti-tachycardia pacing (ATP) therapy administration for appropriate or inappropriate arrhythmia detection
Description
Number of ATP occurrences
Time Frame
Within 12 months following LVAD implant
Title
Frequency of ICD generator change prior to definitive therapy
Description
Number of patients requiring ICD generator change
Time Frame
Within 12 months following LVAD implant
Title
Cardiac implantable electronic device (CIED) battery voltage/estimated longevity changes
Description
Battery voltage and battery life measured in days
Time Frame
Within 12 months following LVAD implant
Title
Frequency of arrhythmic syncope
Description
Number of syncope occurrences
Time Frame
Within 12 months following LVAD implant
Title
Hospitalization frequency for decompensated congestive heart failure
Description
Number of hospitalizations
Time Frame
Within 12 months following LVAD implant
Title
Determine survival to heart transplantation following LVAD implant
Description
Number of patients, post LVAD implant, to receive heart transplant and number of survival days post implant
Time Frame
Within 12 months following LVAD implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion:
Age ≥ 18
Advanced Heart Failure
Scheduled for Heartmate II LVAD implant
With existing ICD
Exclusion:
-Age < 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Ellis, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29475875
Citation
Richardson TD, Hale L, Arteaga C, Xu M, Keebler M, Schlendorf K, Danter M, Shah A, Lindenfeld J, Ellis CR. Prospective Randomized Evaluation of Implantable Cardioverter-Defibrillator Programming in Patients With a Left Ventricular Assist Device. J Am Heart Assoc. 2018 Feb 23;7(5):e007748. doi: 10.1161/JAHA.117.007748.
Results Reference
derived
Learn more about this trial
Prospective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).
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