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

NCT04264182 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-06-08

No results posted yet for this study

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

Interventions

OTHER

ICD programming

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

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Daniel Cantillon, M. D. · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-03
Primary Completion
2022-04-04
Completion
2022-04-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04264182 on ClinicalTrials.gov