Effect of the MobiusHD® in Patients With Heart Failure

Heart Failure With Reduced Ejection Fraction Clinical Trial

— HF-FIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04590001
• Other study ID #: CRD0593 0594 0595 0596 0610
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: June 2026

Study information

• Verified date: February 2024
• Source: Vascular Dynamics, Inc.
• Contact: Lisa Director, Clinical Operations
• Phone: (949) 231-7602
• Email: lgreen[@]vasculardynamics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Device:
• MobiusHD
The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital	Darlinghurst	Sydney
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Canada	London Health Science Center	London	Ontario
Canada	Montreal Heart Institute	Montreal	Quebec
Georgia	Helsicore Ltd "Israeli-Georgian Medical Research Clinic Helsicore"	Tbilisi
Georgia	Tbilisi Heart and Vascular Center	Tbilisi
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Heart Center, University Hospital Dresden	Dresden
Germany	CardioVascular Center - CVC Frankfurt	Frankfurt
Germany	Justus-Liebig-Universitat Giessen	Gießen
Germany	University of Saarlandes - Homburg	Homburg
Germany	Krankenhaus der Barmherzigen Brüder Trier	Trier
Germany	University Hospital Ulm	Ulm
Serbia	Clinical Hospital Center Bežanijska Kosa, Belgrade	Belgrade
Serbia	Institut for Cardiovascular Disease Dedinje, Belgrade	Belgrade
Serbia	University Clinical Center, Kragujevac	Kragujevac
Serbia	Institute for Cardiovascular Disease of Vojvodina	Sremska Kamenica

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Dynamics, Inc.

Countries where clinical trial is conducted

Australia,  Canada,  Georgia,  Germany,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 months
Primary	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	24 months
Primary	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.	24 months
Primary	Change in 6MHW distance	Change in 6MHW distance between baseline and 3 months, 6 months, 12 months, 18 months and 24 months	24 months
Primary	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.	24 months
Primary	Adverse Events	Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events	24 months
Primary	Cardiovascular Mortality	Rate of cardiovascular mortality throughout the follow-up period will be reported.	24 months
Primary	Heart Failure Hospitalizations	Rate of heart failure hospitalizations throughout the follow-up period will be reported.	24 months