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

Primary Purpose

Heart Failure With Reduced Ejection Fraction

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MobiusHD
Sponsored by
Vascular Dynamics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring Heart Failure, Mobius HD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 years or above
  2. Currently NYHA Class II or III 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
  8. Adequacy of the carotid anatomy for treatment with the MobiusHD implant based on non-invasive carotid duplex and CTA/MRA imaging, and invasive carotid angiography

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

Sites / Locations

  • St. Vincent's HospitalRecruiting
  • Fiona Stanley HospitalRecruiting
  • London Health Science CenterRecruiting
  • Montreal Heart InstituteRecruiting
  • Helsicore Ltd "Israeli-Georgian Medical Research Clinic Helsicore"Recruiting
  • Tbilisi Heart and Vascular CenterRecruiting
  • Charité Universitätsmedizin BerlinRecruiting
  • Heart Center, University Hospital DresdenRecruiting
  • CardioVascular Center - CVC FrankfurtRecruiting
  • Justus-Liebig-Universitat GiessenRecruiting
  • University of Saarlandes - HomburgRecruiting
  • Krankenhaus der Barmherzigen Brüder TrierRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MobiusHD

Arm Description

Each subject enrolled in the study will undergo implantation of the MobiusHD device.

Outcomes

Primary Outcome Measures

Change in New York Heart Association Heart Failure Class
Change in New York Heart Association Heart Failure Class between baseline and 3 months, 6 months, 12 months, 18 months and 24 months
Change in NT-proBNP blood test levels
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
Change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EQ-5D Questionnaire.
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.
Change in 6MHW distance
Change in 6MHW distance between baseline and 3 months, 6 months, 12 months, 18 months and 24 months
Change in cardiac function / structure
Change will be evaluated using echocardiogram measured left ventricular ejection fraction, LV end diastolic volume, left atrial volume index, and severity of mitral regurgitation.
Adverse Events
Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events
Cardiovascular Mortality
Rate of cardiovascular mortality throughout the follow-up period will be reported.
Heart Failure Hospitalizations
Rate of heart failure hospitalizations throughout the follow-up period will be reported.

Secondary Outcome Measures

Full Information

First Posted
October 5, 2020
Last Updated
October 4, 2023
Sponsor
Vascular Dynamics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04590001
Brief Title
Effect of the MobiusHD® in Patients With Heart Failure
Acronym
HF-FIM
Official Title
A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Dynamics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Subjects presenting with Class II or III 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction
Keywords
Heart Failure, Mobius HD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MobiusHD
Arm Type
Experimental
Arm Description
Each subject enrolled in the study will undergo implantation of the MobiusHD device.
Intervention Type
Device
Intervention Name(s)
MobiusHD
Intervention Description
The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.
Primary Outcome Measure Information:
Title
Change in New York Heart Association Heart Failure Class
Description
Change in New York Heart Association Heart Failure Class between baseline and 3 months, 6 months, 12 months, 18 months and 24 months
Time Frame
24 months
Title
Change in NT-proBNP blood test levels
Description
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
Time Frame
24 months
Title
Change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EQ-5D Questionnaire.
Description
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.
Time Frame
24 months
Title
Change in 6MHW distance
Description
Change in 6MHW distance between baseline and 3 months, 6 months, 12 months, 18 months and 24 months
Time Frame
24 months
Title
Change in cardiac function / structure
Description
Change will be evaluated using echocardiogram measured left ventricular ejection fraction, LV end diastolic volume, left atrial volume index, and severity of mitral regurgitation.
Time Frame
24 months
Title
Adverse Events
Description
Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events
Time Frame
24 months
Title
Cardiovascular Mortality
Description
Rate of cardiovascular mortality throughout the follow-up period will be reported.
Time Frame
24 months
Title
Heart Failure Hospitalizations
Description
Rate of heart failure hospitalizations throughout the follow-up period will be reported.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or above Currently NYHA Class II or III heart failure Left ventricular ejection fraction ≤ 40% NT-proBNP ≥ 400 Prescribed optimally-tolerated, stable, Guideline Directed Medical Therapy (GDMT) per country specific guidelines for the treatment of heart failure for at least 4 weeks Six-minute hall walk (6MHW) distance of ≥ 150 m AND ≤ 400 m Deemed an acceptable candidate for the implant procedure by the investigator Exclusion Criteria: Known or clinically suspected baroreflex failure or autonomic neuropathy Currently implanted with a barostimulator device Received cardiac resynchronization therapy (CRT) within six months of implantation Received a CardioMEMS device within three months of the screening visit History of any prior stroke with permanent neurologic defect or any prior intracranial bleed or other serious brain injury Body mass index > 45 Serum estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 Presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Director, Clinical Operations
Phone
(949) 231-7602
Email
lgreen@vasculardynamics.com
Facility Information:
Facility Name
St. Vincent's Hospital
City
Darlinghurst
State/Province
Sydney
ZIP/Postal Code
NSW 2010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika O'Dea
Email
erika.odea@svha.org.au
First Name & Middle Initial & Last Name & Degree
David Muller, MD
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gillian Tulloch
Email
gillian.tulloch@health.wa.gov.au
First Name & Middle Initial & Last Name & Degree
Amit Shah, MD
Facility Name
London Health Science Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Hern
Phone
5196858500
Email
heather.hern@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Stuart Smith, MD
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helene Brown
Email
helene.brown@icm-mhi.org
First Name & Middle Initial & Last Name & Degree
Anique Ducharme, MD
Facility Name
Helsicore Ltd "Israeli-Georgian Medical Research Clinic Helsicore"
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Bekaia
Facility Name
Tbilisi Heart and Vascular Center
City
Tbilisi
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Shaburishvili
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katharina Gille
Email
katharina.gille@dhzc-charite.de
First Name & Middle Initial & Last Name & Degree
Mohammad Sherif, Prof. dr. med
Facility Name
Heart Center, University Hospital Dresden
City
Dresden
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecile Bosredon
Email
cecile.bosredon1@tu-dresden.de
First Name & Middle Initial & Last Name & Degree
Axel Linke, Prof. dr. med
Facility Name
CardioVascular Center - CVC Frankfurt
City
Frankfurt
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefanie Schlimm
Email
s.schlimm@cvcfrankfurt.de
First Name & Middle Initial & Last Name & Degree
Horst Sievert, Prof. dr. med
Facility Name
Justus-Liebig-Universitat Giessen
City
Gießen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Drewenka
Email
anne.drewenka@innere.med.uni-giessen.de
First Name & Middle Initial & Last Name & Degree
Christian Hamm, Prof. dr med
Facility Name
University of Saarlandes - Homburg
City
Homburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Koch
Email
christina.koch@uks.edu
First Name & Middle Initial & Last Name & Degree
Felix Mahfoud, Prof. dr. med
Facility Name
Krankenhaus der Barmherzigen Brüder Trier
City
Trier
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Waschbuesch
Email
h.waschbuesch@bbtgruppe.de
First Name & Middle Initial & Last Name & Degree
Jurgen Leick, Dr. med

12. IPD Sharing Statement

Learn more about this trial

Effect of the MobiusHD® in Patients With Heart Failure

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