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Arrythmia Burden in Cardiac Contractility Modulation (CCM)
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).
Conditions:
🦠 Atrial Fibrillation 🦠 Arrythmia
🗓️ Study Start (Actual) 1 May 2023
🗓️ Primary Completion (Estimated) 30 April 2025
✅ Study Completion (Estimated) 30 April 2025
👥 Enrollment (Estimated) 200
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Hackensack, New Jersey, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 January 2023
  • First Submitted that Met QC Criteria 20 January 2023
  • First Posted 30 January 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 May 2023
  • Last Update Posted 15 May 2023
  • Last Verified May 2023
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