Arrythmia Burden in Cardiac Contractility Modulation (CCM)

Study Overview
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Brief Summary
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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).

Official Title
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Arrhythmia Burden in Patients With Impulse Dynamics Optimizer Cardiac Contractility Modulation (CCM) Device Implantation: Retrospective and Prospective Evaluation

Conditions
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Arrythmia, Atrial Fibrillation

Intervention / Treatment
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* Device: Impulse Dynamics Optimizer Device


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective<br>Patients with available data for 6 months before the implantation of the Optimizer implantation and at least 8 months after the implantation of the optimizer at the time the study is initiated and patients with available data for 6 months before the implantation of the Optimizer implantation, but less than 8 months of follow up after Optimizer implantation at the time of the study initiation. | Device: Impulse Dynamics Optimizer Device<br>* 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.<br>|
| Prospective<br>Patients prior to the implantation of the Optimizer that will take place as per standard of care. | Device: Impulse Dynamics Optimizer Device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 months post optimizer implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impulse Dynamics Optimizer Device, Heart failure, Cardiovascular implantable electronic device, Atrial Fibrillation, Reduced ejection fraction, Internal cardioverter defibrillator, Permanent pacemaker, Arrythmia, Cardiac Contractility Modulation