Arrythmia Burden in Cardiac Contractility Modulation (CCM)

Hackensack Meridian Health2 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Atrial Fibrillation Arrythmia

Interventions

Impulse Dynamics Optimizer DeviceDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 1%≤AF burden≤99% in the 6 month period prior to Optimizer implant as documented the patient's CIED 2. 18 years of age or older on day of signing consent 3. Any gender 4. Functional pacemaker or ICD and using remote follow-up for their CEID 5. Not scheduled for planned catheter ablation or cardioversion 6. Ability to sign consent in English or Spanish Exclusion Criteria: 1. Permanent atrial fibrillation 2. Pregnancy (in prospective arm only) 3. Expected survival \<1 year

Outcomes

Primary Outcomes

Change in Atrial Fibrillation (AF) Burden

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

Time frame: 8 months post optimizer implantation