Effect of the MobiusHD® in Patients With Heart Failure

ClinicalTrials.gov ID

NCT04590001

Lead Sponsor

Vascular Dynamics, Inc.INDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

50Estimated

Last Update Posted

Feb 14, 2024Actual

Start Date

Oct 2, 2020Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Jun 2026Estimated

Official Title

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

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.

• Heart Failure With Reduced Ejection Fraction

• MobiusHD

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Vascular Dynamics, Inc.INDUSTRY

heather.hern@lhsc.on.ca5196858500

helene.brown@icm-mhi.org

katharina.gille@dhzc-charite.de

cecile.bosredon1@tu-dresden.de

s.schlimm@cvcfrankfurt.de

anne.drewenka@innere.med.uni-giessen.de

christina.koch@uks.edu

h.waschbuesch@bbtgruppe.de

Uta.Dichristin@uniklinik-ulm.de+4973150045250

rada.vucic@gmail.com+381631123610

• Effect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension

  NCT05352425

  WithdrawnInterventionalNot ApplicableUpdated May 10, 2023
• Controlling and Lowering Blood Pressure With The MOBIUS HD™ (CALM-FIM_EUR)

  NCT01911897

  CompletedInterventionalNot ApplicableUpdated Nov 22, 2023
• Controlling and Lowering Blood Pressure With The MOBIUSHD™

  NCT01831895

  CompletedInterventionalNot ApplicableUpdated May 6, 2023
• Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure

  NCT01045343

  CompletedInterventionalNot ApplicableUpdated Apr 17, 2012
• Controlling and Lowering Blood Pressure With the MobiusHD™

  NCT02827032

  Unknown statusInterventionalNot ApplicableUpdated Oct 6, 2023
• CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™

  NCT03179800

  Unknown statusInterventionalNot ApplicableUpdated Jul 18, 2024