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STandardized Ultra-conservative Or Physician-directed ICD Programming for Continuous Flow LVAD Support

Primary Purpose

Heart Failure, Systolic, Left Ventricular Assist Device, ICD

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ICD programming
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Systolic focused on measuring LVAD, ICD, Shock, Ventricular arrhythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pre-existing ICD
  • LVAD placement

Exclusion Criteria:

  • Non-functional ICD system
  • Uncontrolled ventricular arrhythmias within 7 days of enrollment (defined as VT/VF >30 seconds and/or causing hemodynamic instability and/or symptoms of pre-syncope or syncope)

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ultra-conservative ICD programming

Standard programming (physician discretion)

Arm Description

Single VF zone programming strategy with maximal detection extension to avoid ICD shock delivery with monitoring-only VT detection zones

Usual care ICD programming, which is historically unchanged from ICD programming pre-LVAD

Outcomes

Primary Outcome Measures

ICD shock delivery
Number of patients with ICD shock delivery
Mortality
Incidence of all-cause death
Syncope
Individual occurrence of loss of consciousness

Secondary Outcome Measures

Time to first ICD shock
Interval of time from baseline to first appropriate/non-appropriate ICD shock
Time to first ICD shock for VT/VF (appropriate shock)
Interval of time from baseline to first ICD shock for VT/VF (appropriate shock)
Standard INTERMACS survey
Quality of life measured by INTERMACS survey scored from 1 to 7
Hospitalization
Individual occurrence of hospitalization

Full Information

First Posted
January 31, 2020
Last Updated
June 6, 2022
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04264182
Brief Title
STandardized Ultra-conservative Or Physician-directed ICD Programming for Continuous Flow LVAD Support
Official Title
STandardized Ultra-conservative Or Physician-directed ICD Programming for SHOCK Reduction Among Patients on Continuous Flow LVAD Support: a Randomized Controlled Trial (STOP SHOCK LVAD Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Difficult to enroll patients into the study
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
April 4, 2022 (Actual)
Study Completion Date
April 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the utilization of an ultra-conservative programming strategy to reduce shocks for ventricular arrhythmias (VA) among patients with heart failure, an implantable cardioverter-defibrillator (ICD) and continuous flow (CF) left ventricular assist device (LVAD). Patients on LVAD support demonstrate unique hemodynamic tolerability of VA, and the role for ICDs among patients with newer generation CF LVADs remains less clear than the older generation devices. Prior studies have explored extended detection ICD programming to reduce unecessary or potentially avoidable shocks to patients. However, no prospective randomized study to-date has evaluated such programming strategies in the CF LVAD patient population. The study hypothesis is that ultra-conservative (UC) ICD programming will result in a reduction of shocks and an improvement in quality of life without increasing hospitalizations, syncope or death among patients on CF LVAD support, and the primary design is a 1:1 randomization between UC programming over standard, physician discretion programming.
Detailed Description
The current International Society for Heart and Lung Transplantation (ISHLT) guidelines provide a class I recommendation for tachy-therapy re-activation in patients with ICDs undergoing LVAD implantation. However, these guidelines reflect a survival benefit observed in cohorts comprised primarily of older-generation pulsatile flow LVADs. While the overall VA prevalence in the LVAD population exceeds 50% with VA usually occurring >200 beats per minute, VA are generally well-tolerated both hemodynamically and symptomatically. Observed LVAD flows do decrease during sustained VA but there are multiple case reports of LVAD patients remaining awake and asymptomatic despite hours of ventricular fibrillation and a large case series reported no deaths and rare syncope due to VA in CF LVAD patients. Contrary to guidelines, contemporary evaluations restricted to CF LVADs show no clear ICD survival benefit in single center studies nor a large, pooled meta-analysis. In fact, propensity-matched analyses of CF LVAD patients in the INTERMACS and UNOS registries have demonstrated increased mortality and more hospitalizations among patients with an active ICD and treated VA. It is unclear in the CF LVAD population whether ICD shocks themselves are harmful or rather identify a higher-acuity patient subgroup. In the general HF population, however, shocks have consistently been associated with worse outcomes. Shock reduction programming resulted in reduced mortality in the MADIT-RIT trial, suggesting shocks may be directly harmful and not only a marker of substrate. Therefore, the present study will evaluate whether ultra-conservative (UC) programming for ICDs can reduce shocks over standard (physician-discretion) programming among patients with heart failure on CF LVAD support. The model is 1:1 randomization between the two programming strategies for patients with newly implanted CF LVAD devices and a pre-existing ICD. They will be eligible for enrollment during their index hospitalization, and after discharge up to their first outpatient follow-up visit no later than 3 months post discharge. The primary endpoints will be any ICD shock, all-cause mortality, and syncope. The secondary endpoints will be time to first ICD shock, time to first ICD shock for VT/VF, quality of life questionnaire and hospitalizations, including for heart failure and ventricular arrhythmias. The principal exclusion criteria will be pediatric patients, or those without a functional ICD system. Standard of care follow-up will continue thru 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic, Left Ventricular Assist Device, ICD
Keywords
LVAD, ICD, Shock, Ventricular arrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective. Randomized control trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultra-conservative ICD programming
Arm Type
Experimental
Arm Description
Single VF zone programming strategy with maximal detection extension to avoid ICD shock delivery with monitoring-only VT detection zones
Arm Title
Standard programming (physician discretion)
Arm Type
No Intervention
Arm Description
Usual care ICD programming, which is historically unchanged from ICD programming pre-LVAD
Intervention Type
Other
Intervention Name(s)
ICD programming
Intervention Description
Re-programming of the ICD device for VA detection (see above)
Primary Outcome Measure Information:
Title
ICD shock delivery
Description
Number of patients with ICD shock delivery
Time Frame
Up to 24 months
Title
Mortality
Description
Incidence of all-cause death
Time Frame
Up to 24 Months
Title
Syncope
Description
Individual occurrence of loss of consciousness
Time Frame
Up to 24 Months
Secondary Outcome Measure Information:
Title
Time to first ICD shock
Description
Interval of time from baseline to first appropriate/non-appropriate ICD shock
Time Frame
Up to 24 Months
Title
Time to first ICD shock for VT/VF (appropriate shock)
Description
Interval of time from baseline to first ICD shock for VT/VF (appropriate shock)
Time Frame
Up to 24 Months
Title
Standard INTERMACS survey
Description
Quality of life measured by INTERMACS survey scored from 1 to 7
Time Frame
Up to 24 Months
Title
Hospitalization
Description
Individual occurrence of hospitalization
Time Frame
Up to 24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pre-existing ICD LVAD placement Exclusion Criteria: Non-functional ICD system Uncontrolled ventricular arrhythmias within 7 days of enrollment (defined as VT/VF >30 seconds and/or causing hemodynamic instability and/or symptoms of pre-syncope or syncope)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Cantillon, M. D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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STandardized Ultra-conservative Or Physician-directed ICD Programming for Continuous Flow LVAD Support

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