Arrythmia Burden in Cardiac Contractility Modulation (CCM)

Stopped early

Conditions studied: Atrial Fibrillation, Arrythmia

In brief

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).

Key facts

Study ID

NCT05704426

Run by

Hackensack Meridian Health

People needed

2

Starts

2023-05-01

Expected to finish

2023-07-18

Last updated by the study team

2024-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Permanent atrial fibrillation
• Pregnancy (in prospective arm only)
• Expected survival <1 year

Where it is running

• Hackensack Univeristy Medical Center — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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