Clinical trial NCT05704426: Arrythmia Burden in Cardiac Contractility Modulation (CCM)
Official title: Arrhythmia Burden in Patients With Impulse Dynamics Optimizer Cardiac Contractility Modulation (CCM) Device Implantation: Retrospective and Prospective Evaluation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Fibrillation
Arrythmia
Keywords: Impulse Dynamics Optimizer Device
Heart failure
Cardiovascular implantable electronic device
Atrial Fibrillation
Reduced ejection fraction
Internal cardioverter defibrillator
Permanent pacemaker
Arrythmia
Cardiac Contractility Modulation
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
Collaborators: name: Impulse Dynamics
First posted: 2023-01-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective patients with the Impulse Dynamics Optimizer Device already implanted and available data for at least 6 months pre-implantation and prospective patients scheduled to have the Impulse Dynamics Optimizer Device implanted as per standard of care.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in Atrial Fibrillation (AF) Burden
timeFrame: 8 months post optimizer implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack Univeristy Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Sameer Jamal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lardizabal JA, Deedwania PC. Atrial fibrillation in heart failure. Med Clin North Am. 2012 Sep;96(5):987-1000. doi: 10.1016/j.mcna.2012.07.007. Epub 2012 Aug 17.
citation: Verma A, Kalman JM, Callans DJ. Treatment of Patients With Atrial Fibrillation and Heart Failure With Reduced Ejection Fraction. Circulation. 2017 Apr 18;135(16):1547-1563. doi: 10.1161/CIRCULATIONAHA.116.026054.
citation: Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575.
citation: Mosterd A, Cost B, Hoes AW, de Bruijne MC, Deckers JW, Hofman A, Grobbee DE. The prognosis of heart failure in the general population: The Rotterdam Study. Eur Heart J. 2001 Aug;22(15):1318-27. doi: 10.1053/euhj.2000.2533.
citation: Saltzman HE. Arrhythmias and heart failure. Cardiol Clin. 2014 Feb;32(1):125-33, ix. doi: 10.1016/j.ccl.2013.09.005. Epub 2013 Oct 18.
citation: Kuschyk J, Falk P, Demming T, Marx O, Morley D, Rao I, Burkhoff D. Long-term clinical experience with cardiac contractility modulation therapy delivered by the Optimizer Smart system. Eur J Heart Fail. 2021 Jul;23(7):1160-1169. doi: 10.1002/ejhf.2202. Epub 2021 May 17.
citation: Piccini JP, Dufton C, Carroll IA, Healey JS, Abraham WT, Khaykin Y, Aleong R, Krueger SK, Sauer WH, Wilton SB, Rienstra M, van Veldhuisen DJ, Anand IS, White M, Camm AJ, Ziegler PD, Marshall D, Bristow MR, Connolly SJ; Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for Prevention of Atrial Fibrillation/Atrial Flutter in Patients with Heart Failure Trial Investigators*. Bucindolol Decreases Atrial Fibrillation Burden in Patients With Heart Failure and the ADRB1 Arg389Arg Genotype. Circ Arrhythm Electrophysiol. 2021 Aug;14(8):e009591. doi: 10.1161/CIRCEP.120.009591. Epub 2021 Jul 16.