Arrythmia Burden in Cardiac Contractility Modulation (CCM) (ABC)

Hackensack Meridian Health

Status: Terminated

Conditions: Arrythmia; Atrial Fibrillation

Treatments: Device: Impulse Dynamics Optimizer Device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05704426

Pro2022-0954

Details and patient eligibility

About

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).

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2 participants in 2 patient groups

Retrospective

Description:

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.

Treatment:

Device: Impulse Dynamics Optimizer Device

Prospective

Description:

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

Treatment:

Device: Impulse Dynamics Optimizer Device