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Arrythmia Burden in Cardiac Contractility Modulation (CCM)

NCT05704426 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2024-08-19

Study results available
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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).

Conditions

Interventions

DEVICE

Impulse Dynamics Optimizer Device

The Impulse Dynamics Optimizer is indicated for patients with New York Heart Association (NYHA) class III congestive heart failure (CHF) with left ventricular ejection fraction (LVEF) between 25 and 45% who are not candidates for cardiac resynchronization therapy. The Optimizer device requires a minimally invasive implant by a cardiac electrophysiologist with two transvenous pacemaker wires implanted into the right ventricular septum and attached to a generator in an infraclavicular region, much like a pacemaker. The Optimizer device provides CCM through improved calcium handling and has been shown to reverse the negative remodeling of the left ventricle seen in HFrEF and improve left ventricular contractile strength.

Sponsors & Collaborators

  • Impulse Dynamics

    collaborator INDUSTRY

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Sameer Jamal, MD · Hackensack Meridian Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-07-18
Completion
2023-07-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05704426 on ClinicalTrials.gov