Cardiac Neuromodulation for Heart Failure

July 14, 2022 updated by: BackBeat Medical Inc

BackBeat Medical Cardiac Neuromodulation Therapy in Patients With Heart Failure: An Acute Feasibility Study

This investigation will evaluate the ability of the Moderato® System to safely and effectively deliver CNT, to reduce sympathetic activity in heart failure patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This will be a single center, non-randomized observational study. The Moderato® System is approved for marketing in Europe (has a CE mark) for the treatment of high blood pressure in patients requiring standard cardiac pacing. The therapy delivered by the Moderato® System is referred to as CNT (Cardiac Neuromodulation Therapy). Heart failure patients is a population for which the Moderato® device is currently not indicated.

Subjects requiring an implantable cardiac defibrillator (ICD) implantation or replacement and meeting study inclusion and exclusion criteria will be eligible to participate in the study. The study procedure will take place during the ICD implantation (or replacement).

The whole procedure will be performed according to standard of care for ICD implantations (or replacements) including periprocedural prophylactic antibiotics prophylactic. To reduce the time of wound exposure, the setup of system for invasive measurements will be done before the ICD implant (or replacement) procedure begins.

The groin area will be prepared and draped. After applying local anesthesia, a 7Fr sheath will be inserted into the femoral artery. A small dose of heparin (~5000 units) will be administered intravenously to prevent formation of blood clots. Under fluoroscopic guidance, a standard conductance catheter (CD Leycom CA-71103-PL, CE marked) will be advanced into the left ventricle.

The arterial line will be used to measure arterial pressure. This completes the measuring system setup.

Then, ICD right atrial lead and right ventricular lead will be implanted in standard positions according to standard institutional practices.

The leads will be connected to a BackBeat Moderato® System IPG, externally to the patient using a single use, sterile Pacing System Analyzer (PSA) cable provided by the hospital. The Moderato® IPG, approved for chronic CNT delivery in hypertensive patients, will function in this trial as a temporary external CNT signal generator for acute application of the therapy.

A range of CNT signal parameters will be used to assess the effect on sympathetic activity. Ventricular pressure and volume readings from the conductance catheter and arterial pressure readings will be recorded and analyzed to assess the effect of CNT signals on cardiac function, sympathetic activity and blood pressure. The effects of CNT signal over a range of parameter settings will be studied over a period of time no longer than one hour.

In this study, none of the Moderato® system components will be in contact with the patient. The Moderato® IPG will be used solely as an external CNT signal generator and deliver signals to the patient through the PSA cable and the ICD leads.

When CNT signal activation is complete, data recording will be stopped, the conductance catheter will be removed, the cable connecting the IPG to the leads disconnected, and ICD implantation will proceed normally.

Study Type

Observational

Enrollment (Anticipated)

11

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 Contact Backup

Study Locations

  • Poland
      • Zabrze, Poland, 41-800
        • Recruiting
        • Silesian Center for Heart Diseases
        • Contact:
        • Principal Investigator:
          • Zbigniew Kalarus, Prof.
        • Sub-Investigator:
          • Adam Sokal, MD, PhD

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

These are Heart Failure subjects willing to participate in a short acute clinical study during the implantation or replacement of a single chamber ICD.

Description

Inclusion Criteria:

  1. Subject is ≥ 18 years of age
  2. Subject has a primary indication and is scheduled for ICD implantation or replacement
  3. Subject has heart failure NYHA Class II or III

Exclusion Criteria:

  1. Subject is to receive a single chamber defibrillator
  2. Subject has an ejection fraction of 25% or less
  3. Subject's systolic blood pressure is less than 120 mm Hg on the day of implant
  4. Subject has decompensated heart failure
  5. Subject has significant (>2+) mitral regurgitation, aortic regurgitation or aortic stenosis.
  6. Subject has permanent atrial fibrillation
  7. Subject has atrial fibrillation on the day of the study.
  8. Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
  9. Subject has a history of prior neurological events (stroke or TIA) within the past year or a neurological event (stroke or TIA) at any prior time that has resulted in residual neurologic deficit.
  10. Subject has a history of autonomic dysfunction
  11. Women who are pregnant or breast-feeding
  12. Subject cannot or is unwilling to provide informed consent.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Arterial Elastance
Time Frame: Immediate, derived form ongoing Pressure Volume changes in the Left ventricle
Arterial elastance is reduced when sympathetic activity is reduced, an indication of a relaxed peripheral resistance.
Immediate, derived form ongoing Pressure Volume changes in the Left ventricle

Collaborators and Investigators

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

Sponsor

BackBeat Medical Inc

Collaborators

CD Leycom

Investigators

  • Principal Investigator: Zbigniew Kalarus, Prof. MD Ph.D, Silesian Center for Heart Diseases

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)

December 15, 2020

Primary Completion (ANTICIPATED)

January 31, 2023

Study Completion (ANTICIPATED)

May 30, 2023

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

September 28, 2020

First Posted (ACTUAL)

October 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 14, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBM HF-CS-01

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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