Effect of the MobiusHD® in Patients With Heart Failure

NCT04590001 | Recruiting DMC

• 1 other identifier: CRD0593 0594 0595 0596 0610
• Study Type: interventional
• Target: 50
• Locations: 5 countries
• Sites: 17

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

Heart Failure; Mobius HD

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• Change in 6MHW distance

  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

  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

  Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events

  24 months

• Cardiovascular Mortality

  Rate of cardiovascular mortality throughout the follow-up period will be reported.

  24 months

• Heart Failure Hospitalizations

  Rate of heart failure hospitalizations throughout the follow-up period will be reported.

  24 months

Study Arms (1)

MobiusHD

EXPERIMENTAL

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

Device: MobiusHD

Interventions

MobiusHD DEVICE

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

MobiusHD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or above
• Currently NYHA Class II, III or ambulatory IV 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vascular Dynamics, Inc.: lead

Study Sites (17)

St. Vincent's Hospital

Darlinghurst, Sydney, NSW 2010, Australia

RECRUITING

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

RECRUITING

London Health Science Center

London, Ontario, N6A 5A5, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Helsicore Ltd "Israeli-Georgian Medical Research Clinic Helsicore"

Tbilisi, Georgia

COMPLETED

Tbilisi Heart and Vascular Center

Tbilisi, Georgia

COMPLETED

Charité Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

Heart Center, University Hospital Dresden

Dresden, Germany

RECRUITING

CardioVascular Center - CVC Frankfurt

Frankfurt, Germany

RECRUITING

Justus-Liebig-Universitat Giessen

Giessen, Germany

RECRUITING

University of Saarlandes - Homburg

Homburg, Germany

RECRUITING

Krankenhaus der Barmherzigen Brüder Trier

Trier, Germany

RECRUITING

University Hospital Ulm

Ulm, Germany

RECRUITING

Clinical Hospital Center Bežanijska Kosa, Belgrade

Belgrade, Serbia

RECRUITING

Institut for Cardiovascular Disease Dedinje, Belgrade

Belgrade, Serbia

RECRUITING

Institute for Cardiovascular Disease of Vojvodina

Kamenitz, Serbia

RECRUITING

University Clinical Center, Kragujevac

Kragujevac, Serbia

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Lisa Director, Clinical Operations

CONTACT

(949) 231-7602; lgreen@vasculardynamics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 19, 2020
• Study Start: October 2, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

DE (7); AU (2); CA (2); GE (2); SE (4)