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Clinical Trial 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).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05704426
Study type Observational
Source Hackensack Meridian Health
Contact Sameer Jamal, MD
Phone 5519965870
Email sameer.jamal@hmhn.org
Status Recruiting
Phase
Start date May 1, 2023
Completion date April 30, 2025

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