Arrythmia Burden in Cardiac Contractility Modulation (CCM)

Terminated

• Conditions: Atrial Fibrillation; Arrythmia
• Interventions: Device: Impulse Dynamics Optimizer Device

• Registration Number: NCT05704426
• Lead Sponsor: Hackensack Meridian Health

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-30
• Study Start: 2023-05-01
• Primary Completion: 2023-07-18
• Study Completion: 2023-07-18
• Results First Submitted: 2023-08-02
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-20
• Last Update Submitted: 2024-03-20
• Results First Posted: 2024-08-19
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective	Impulse Dynamics Optimizer Device	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.
Prospective	Impulse Dynamics Optimizer Device	Patients prior to the implantation of the Optimizer that will take place as per standard of care.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hackensack Univeristy Medical Center; 🇺🇸 Hackensack, New Jersey, United States