Arrythmia Burden in Cardiac Contractility Modulation (CCM)

Atrial Fibrillation Clinical Trial

— ABC  

Official title:

Arrhythmia Burden in Patients With Impulse Dynamics Optimizer Cardiac Contractility Modulation (CCM) Device Implantation: Retrospective and Prospective Evaluation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05704426
• Other study ID #: Pro2022-0954
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2023
• Source: Hackensack Meridian Health
• Contact: Sameer Jamal, MD
• Phone: 5519965870
• Email: sameer.jamal[@]hmhn.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia
• Atrial Fibrillation

Intervention

Device:
• Impulse Dynamics Optimizer Device
The Impulse Dynamics Optimizer is indicated for patients with New York Heart Association (NYHA) class III congestive heart failure (CHF) with left ventricular ejection fraction (LVEF) between 25 and 45% who are not candidates for cardiac resynchronization therapy. The Optimizer device requires a minimally invasive implant by a cardiac electrophysiologist with two transvenous pacemaker wires implanted into the right ventricular septum and attached to a generator in an infraclavicular region, much like a pacemaker. The Optimizer device provides CCM through improved calcium handling and has been shown to reverse the negative remodeling of the left ventricle seen in HFrEF and improve left ventricular contractile strength.

Locations

Country	Name	City	State
United States	Hackensack Univeristy Medical Center	Hackensack	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Hackensack Meridian Health	Impulse Dynamics

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Erratum In: N Engl J Med. 2016 Mar 10;374(10):998. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Atrial fibrillation (AF) burden	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	8 months post optimizer implantation