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NCT05704426 · ClinicalTrials.gov registry record
Arrythmia Burden in Cardiac Contractility Modulation (CCM)
A clinical trial, sponsored by Hackensack Meridian Health.
- Terminated
- Registry status
- 2
- Enrollment target
NCT05704426: Clinical Trial study, sponsored by Hackensack Meridian Health.
NCT05704426 is a clinical trial that was terminated before completion, run by Hackensack Meridian Health. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05704426 was terminated before completion, sponsored by Hackensack Meridian Health.
- TERMINATED
- Registry status
- 2 participants
- Enrollment target
Study Summary
The Impulse Dynamics Optimizer Device is a Food and Drug Administration (FDA) approved; commercially available device indicated for patients with heart failure with reduced ejection fraction (HFrEF). Many candidates of this device have a previously implanted cardiovascular implantable electronic device (CIED)- internal cardioverter defibrillator (ICD) or permanent pacemaker (PM). Patients with heart failure are at high risk for both atrial and ventricular cardiac arrhythmias. The aim of this study is to evaluate patients for Atrial fibrillation (AF) burden episode data obtained from interrogation of their CIED 8 months or greater after Optimizer implant and compare arrhythmia burden 6 months before Optimizer Cardiac Contractility Modulation (CCM) device insertion to 8 months or greater after Optimizer insertion (after 2 month blanking period).
Primary Outcome
Compare the AF burden noted 6 months pre Optimizer implant to 6 post Optimizer months (post Optimizer months 3-8), after 2 month blanking period
Interventions
- DEVICE Impulse Dynamics Optimizer Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2023-05-01 |
| Est. Completion | 2023-07-18 |
Why NCT05704426 stopped before completion
NCT05704426 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Impulse Dynamics Optimizer Device is the first listed.
NCT05704426 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05704426 about?
NCT05704426 is a clinical study titled "Arrythmia Burden in Cardiac Contractility Modulation (CCM)". The Impulse Dynamics Optimizer Device is a Food and Drug Administration (FDA) approved; commercially available device indicated for patients with heart failure with reduced ejection fraction (HFrEF). Many candidates of this device have a previously implanted cardiovascular implantable electronic dev...
What is the current status of trial NCT05704426?
This trial is currently terminated. The enrollment target is 2 participants. The study started on 2023-05-01. Estimated completion is 2023-07-18.
What interventions are being tested in trial NCT05704426?
The interventions under investigation include: Impulse Dynamics Optimizer Device (DEVICE).
Who is sponsoring clinical trial NCT05704426?
This trial is sponsored by Hackensack Meridian Health, which has 90 total clinical trials registered on ClinicalTrials.gov.
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