Arrythmia Burden in Cardiac Contractility Modulation (CCM)

NCT05704426 | Terminated Results

• 1 other identifier: Pro2022-0954
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Retrospective

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.

Device: Impulse Dynamics Optimizer Device

Prospective

Patients prior to the implantation of the Optimizer that will take place as per standard of care.

Device: Impulse Dynamics Optimizer Device

Interventions

Impulse Dynamics Optimizer Device 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.

Prospective; Retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• %≤AF burden≤99% in the 6 month period prior to Optimizer implant as documented the patient's CIED
• years of age or older on day of signing consent
• Any gender
• Functional pacemaker or ICD and using remote follow-up for their CEID
• Not scheduled for planned catheter ablation or cardioversion
• Ability to sign consent in English or Spanish

You may not qualify if:

• Permanent atrial fibrillation
• Pregnancy (in prospective arm only)
• Expected survival \<1 year

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• Impulse Dynamics: collaborator

Study Sites (1)

Hackensack Univeristy Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (7)

• 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.

  PMID: 22980060 BACKGROUND

• 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.

  PMID: 28416525 BACKGROUND

• 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.

  PMID: 22236222 BACKGROUND

• 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.

  PMID: 11465964 BACKGROUND

• 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.

  PMID: 24286583 BACKGROUND

• 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.

  PMID: 34002440 BACKGROUND

• 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.

  PMID: 34270905 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was terminated after only two patients in the retrospective cohort were included. No study activities were conducted for the prospective cohort and there was no formal statistical analysis conducted given the very limited sample size.

Results Point of Contact

• Title: Sameer Jamal, MD
• Organization: Hackensack Meridian Health

Sameer.Jamal@hmhn.org

15519962997

Study Officials

• Sameer Jamal, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 30, 2023
• Study Start: May 1, 2023
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2023
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)