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NCT04264182 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by The Cleveland Clinic.

Terminated
Registry status
NA
Development phase
11
Enrollment target

NCT04264182 is a NA study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 11 participants.

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The verdict

NCT04264182, a NA study, was terminated before completion, sponsored by The Cleveland Clinic.

TERMINATED
Registry status
NA
Development phase
11 participants
Enrollment target

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.

Interventions

  • OTHER ICD programming

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2020-02-03
Est. Completion 2022-04-04
Phase NA

Sponsor

The Cleveland Clinic

688 total trials

What the Registry Record Tells You About NCT04264182

The ClinicalTrials.gov registry entry for NCT04264182 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which ICD programming is the first listed.

NCT04264182 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04264182 about?

NCT04264182 is a clinical study titled "STandardized Ultra-conservative Or Physician-directed ICD Programming for Continuous Flow LVAD Support". 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...

What is the current status of trial NCT04264182?

This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2020-02-03. Estimated completion is 2022-04-04.

What interventions are being tested in trial NCT04264182?

The interventions under investigation include: ICD programming (OTHER).

Who is sponsoring clinical trial NCT04264182?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.