Effect of the MobiusHD® in Patients With Heart Failure (HF-FIM)

February 12, 2024 updated by: Vascular Dynamics, Inc.

A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure

This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and effectiveness of the MobiusHD® in patients with heart failure and reduced ejection fraction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects presenting with Class II, III or ambulatory IV heart failure with a left ventricular ejection fraction of ≤ 40% and NT-proBNP ≥ 400 will be considered for the study. Subjects who meet the initial screening requirements will undergo non-invasive imaging of the carotid anatomy to assess adequacy of the anatomy to allow placement of the MobiusHD device. Eligible subjects will receive an implant placed in the internal carotid artery.

Following implantation of the device, subjects will be seen at 1 week, 1, 3, 6, 12, 18, and 24 months.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

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

  • Australia
    • Sydney
      • Darlinghurst, Sydney, Australia, NSW 2010
        • Recruiting
        • St. Vincent's Hospital
        • Principal Investigator:
          • David Muller, MD
        • Contact:
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London Health Science Center
        • Contact:
        • Principal Investigator:
          • Stuart Smith, MD
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Recruiting
        • Montreal Heart Institute
        • Contact:
        • Principal Investigator:
          • Anique Ducharme, MD
  • Georgia
      • Tbilisi, Georgia
        • Completed
        • Helsicore Ltd "Israeli-Georgian Medical Research Clinic Helsicore"
      • Tbilisi, Georgia
        • Completed
        • Tbilisi Heart and Vascular Center
  • Germany
      • Berlin, Germany
        • Recruiting
        • Charité Universitätsmedizin Berlin
        • Contact:
        • Principal Investigator:
          • Mohammad Sherif, Prof. dr. med
      • Dresden, Germany
        • Recruiting
        • Heart Center, University Hospital Dresden
        • Contact:
        • Principal Investigator:
          • Axel Linke, Prof. dr. med
      • Frankfurt, Germany
        • Recruiting
        • CardioVascular Center - CVC Frankfurt
        • Principal Investigator:
          • Horst Sievert, Prof. dr. med
        • Contact:
      • Gießen, Germany
      • Homburg, Germany
        • Recruiting
        • University of Saarlandes - Homburg
        • Principal Investigator:
          • Felix Mahfoud, Prof. Dr. med
        • Contact:
      • Trier, Germany
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder Trier
        • Contact:
        • Principal Investigator:
          • Jurgen Leick, Dr. med
      • Ulm, Germany
        • Recruiting
        • University Hospital Ulm
        • Contact:
        • Principal Investigator:
          • Wolfgang Rottbauer, Prod. dr. med
  • Serbia
      • Belgrade, Serbia
        • Recruiting
        • Clinical Hospital Center Bežanijska Kosa, Belgrade
        • Contact:
        • Principal Investigator:
          • Marija Zdravković, Prof. dr.
      • Belgrade, Serbia
        • Recruiting
        • Institut for Cardiovascular Disease Dedinje, Belgrade
        • Contact:
        • Principal Investigator:
          • Dragana Košević, Dr.
      • Kragujevac, Serbia
        • Recruiting
        • University Clinical Center, Kragujevac
        • Contact:
        • Principal Investigator:
          • Miodrag Srećković, Prof. dr.
      • Sremska Kamenica, Serbia
        • Recruiting
        • Institute for Cardiovascular Disease of Vojvodina
        • Principal Investigator:
          • Milovan Petrovic, MD
        • Contact:
          • Milovan Petrovic, MD

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

Description

Inclusion Criteria:

  1. Age 18 years or above
  2. Currently NYHA Class II, III or ambulatory IV heart failure
  3. Left ventricular ejection fraction ≤ 40%
  4. NT-proBNP ≥ 400
  5. Prescribed optimally-tolerated, stable, Guideline Directed Medical Therapy (GDMT) per country specific guidelines for the treatment of heart failure for at least 4 weeks
  6. Six-minute hall walk (6MHW) distance of ≥ 150 m AND ≤ 400 m
  7. Deemed an acceptable candidate for the implant procedure by the investigator

Exclusion Criteria:

  1. Known or clinically suspected baroreflex failure or autonomic neuropathy
  2. Currently implanted with a barostimulator device
  3. Received cardiac resynchronization therapy (CRT) within six months of implantation
  4. Received a CardioMEMS device within three months of the screening visit
  5. History of any prior stroke with permanent neurologic defect or any prior intracranial bleed or other serious brain injury
  6. Body mass index > 45
  7. Serum estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
  8. Presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex
  9. Internal ICA lumen diameters <5.0 mm or >11.75 mm within the planned location of the implant placement, or evidence of landing zone restrictions, such as inadequate length, vessel tapering, and/or vessel curvature that would preclude safe placement of the implant

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MobiusHD
Each subject enrolled in the study will undergo implantation of the MobiusHD device.
Device: MobiusHD
The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in New York Heart Association Heart Failure Class
Time Frame: 24 months
Change in New York Heart Association Heart Failure Class between baseline and 3 months, 6 months, 12 months, 18 months and 24 months
24 months
Change in NT-proBNP blood test levels
Time Frame: 24 months
Change in Amino-terminal prohormone of brain natriuretic peptide (NT-proBNP) between baseline and 3 months, 6 months, 12 months, 18 months, and 24 months
24 months
Change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EQ-5D Questionnaire.
Time Frame: 24 months
Change in QoL measures between baseline and 3 months, 6 months, 12 months, 18 months, and 24 months will be measured. The KCCQ is used to measure the effect of heart failure on quality of life with a lower score indicating a worsening quality of life. The EQ-5D Questionnaire is a general measure of overall health with a lower score indicating a better overall health perception.
24 months
Change in 6MHW distance
Time Frame: 24 months
Change in 6MHW distance between baseline and 3 months, 6 months, 12 months, 18 months and 24 months
24 months
Change in cardiac function / structure
Time Frame: 24 months
Change will be evaluated using echocardiogram measured left ventricular ejection fraction, LV end diastolic volume, left atrial volume index, and severity of mitral regurgitation.
24 months
Adverse Events
Time Frame: 24 months
Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events
24 months
Cardiovascular Mortality
Time Frame: 24 months
Rate of cardiovascular mortality throughout the follow-up period will be reported.
24 months
Heart Failure Hospitalizations
Time Frame: 24 months
Rate of heart failure hospitalizations throughout the follow-up period will be reported.
24 months

Collaborators and Investigators

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

Sponsor

Vascular Dynamics, Inc.

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)

October 2, 2020

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

October 9, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD0593 0594 0595 0596 0610

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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