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NCT05704426
Arrythmia Burden in Cardiac Contractility Modulation (CCM)
Conditions: Atrial Fibrillation, Arrythmia
Sex: All
Ages: 18 Years – N/A
Enrollment: 200
Sponsor: Hackensack Meridian Health
Location: United States
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).
Eligibility Criteria
Inclusion Criteria:1%≤AF burden≤99% in the 6 month period prior to Optimizer implant as documented the patient's CIED18 years of age or older on day of signing consentAny genderFunctional dual chamber pacemaker or ICD and using remote follow up for their CIEDNot scheduled for planned catheter ablation or cardioversionAbility to sign consent in English or SpanishExclusion Criteria:Permanent atrial fibrillationPregnancy (in prospective arm only)Expected survival <1 year
Source: ClinicalTrials.gov (NCT05704426). StuddyBuddy aggregates publicly available trial information.