ABC: Arrythmia Burden in Cardiac Contractility Modulation (CCM)

Sponsor

Hackensack Meridian Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05704426

Collaborator

Impulse Dynamics, Inc. (Other)

200

Enrollment

Location

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Arrythmia	Device: Impulse Dynamics Optimizer Device

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Jan 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Retrospective 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 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.
Prospective Patients prior to the implantation of the Optimizer that will take place as per standard of care.	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.

Arm

Intervention/Treatment

Retrospective

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

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.

Prospective

Patients prior to the implantation of the Optimizer that will take place as per standard of care.

Device: Impulse Dynamics Optimizer Device

Outcome Measures

Primary Outcome Measures

Change in Atrial fibrillation (AF) burden [8 months post optimizer implantation]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 dual chamber pacemaker or ICD and using remote follow up for their CIED
Not scheduled for planned catheter ablation or cardioversion
Ability to sign consent in English or Spanish