Effect of the MobiusHD® in Patients With Heart Failure

Not Applicable

Recruiting

• Conditions: Heart Failure With Reduced Ejection Fraction
• Interventions: Device: MobiusHD

• Registration Number: NCT04590001
• Lead Sponsor: Vascular Dynamics, Inc.

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, 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 Timeline

• Study Start: 2020-10-02
• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-14
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (17)

Fiona Stanley Hospital; 🇦🇺 Murdoch, Western Australia, Australia

Institut for Cardiovascular Disease Dedinje, Belgrade; 🇷🇸 Belgrade, Serbia

Clinical Hospital Center Bežanijska Kosa, Belgrade; 🇷🇸 Belgrade, Serbia

Helsicore Ltd "Israeli-Georgian Medical Research Clinic Helsicore"; 🇬🇪 Tbilisi, Georgia

Tbilisi Heart and Vascular Center; 🇬🇪 Tbilisi, Georgia

Institute for Cardiovascular Disease of Vojvodina; 🇷🇸 Sremska Kamenica, Serbia

Heart Center, University Hospital Dresden; 🇩🇪 Dresden, Germany

London Health Science Center; 🇨🇦 London, Ontario, Canada

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, 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 Clinical Center, Kragujevac; 🇷🇸 Kragujevac, Serbia

University Hospital Ulm; 🇩🇪 Ulm, Germany

St. Vincent's Hospital; 🇦🇺 Darlinghurst, Sydney, Australia

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada