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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: Clinical Trial NA study, sponsored by The Cleveland Clinic.
NCT04264182 is a NA study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of patients with ICD shock delivery
Interventions
- OTHER ICD programming
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-02-03 |
| Est. Completion | 2022-04-04 |
| Phase | NA |
Why NCT04264182 stopped before completion
NCT04264182 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which ICD programming is the first listed.
NCT04264182 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04264182's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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