Arrythmia Burden in Cardiac Contractility Modulation (CCM) (ABC)

May 11, 2023 updated by: Hackensack Meridian Health

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack Univeristy Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Patients prior to the implantation of the Optimizer that will take place as per standard of care.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Atrial fibrillation (AF) burden
Time Frame: 8 months post optimizer implantation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hackensack Meridian Health

Collaborators

Impulse Dynamics

Investigators

  • Principal Investigator: Sameer Jamal, MD, Hackensack Meridian Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Anticipated)

April 30, 2025

Study Completion (Anticipated)

April 30, 2025

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2022-0954

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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