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

NCT04264182 | Terminated

• 1 other identifier: 19-656
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Systolic; Left Ventricular Assist Device; ICD

Keywords

LVAD; ICD; Shock; Ventricular arrhythmia

Outcome Measures

Primary Outcomes (3)

• ICD shock delivery

  Number of patients with ICD shock delivery

  Up to 24 months

• Mortality

  Incidence of all-cause death

  Up to 24 Months

• Syncope

  Individual occurrence of loss of consciousness

  Up to 24 Months

Secondary Outcomes (4)

• Time to first ICD shock

  Up to 24 Months

• Time to first ICD shock for VT/VF (appropriate shock)

  Up to 24 Months

• Standard INTERMACS survey

  Up to 24 Months

• Hospitalization

  Up to 24 Months

Study Arms (2)

Ultra-conservative ICD programming

EXPERIMENTAL

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

Other: ICD programming

Standard programming (physician discretion)

NO INTERVENTION

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

Interventions

ICD programming OTHER

Re-programming of the ICD device for VA detection (see above)

Ultra-conservative ICD programming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre-existing ICD
• LVAD placement

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Shock

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Cantillon, M. D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective. Randomized control trial.

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 11, 2020
• Study Start: February 3, 2020
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)