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

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ClinicalTrials.gov Identifier: NCT04590001
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure With Reduced Ejection Fraction Device: MobiusHD Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study Exploring the Effect of the MobiusHD® in Patients With Heart Failure
Actual Study Start Date : October 2, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: MobiusHD
Each subject enrolled in the study will undergo implantation of the MobiusHD device.
Device: MobiusHD
The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.




Primary Outcome Measures :
  1. Change in New York Heart Association Heart Failure Class [ Time Frame: 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

  2. Change in NT-proBNP blood test levels [ Time Frame: 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

  3. Change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EQ-5D Questionnaire. [ Time Frame: 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.

  4. Change in 6MHW distance [ Time Frame: 24 months ]
    Change in 6MHW distance between baseline and 3 months, 6 months, 12 months, 18 months and 24 months

  5. Change in cardiac function / structure [ Time Frame: 6 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.

  6. Change in cardiac function / structure [ Time Frame: 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.

  7. Adverse Events [ Time Frame: 24 months ]
    Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events

  8. Cardiovascular Mortality [ Time Frame: 24 months ]
    Rate of cardiovascular mortality throughout the follow-up period will be reported.

  9. Heart Failure Hospitalizations [ Time Frame: 24 months ]
    Rate of heart failure hospitalizations throughout the follow-up period will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 <4.5 mm or >12.5 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590001


Contacts
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Contact: Sr. Director, Clinical (949) 942-1640 rnangia@vasculardynamics.com
Contact: Sr. Director, Clinical (650) 208-1118 tshipman@vasculardynamics.com

Locations
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Australia, Queensland
GenesisCare Bundaberg Recruiting
Bundaberg, Queensland, Australia, 4670
Contact: Karen Fox         
GenesisCare Greenslopes Recruiting
Greenslopes, Queensland, Australia, 4120
Contact: Sonia Nelson         
Australia, South Australia
GenesisCare Leabrook Recruiting
Adelaide, South Australia, Australia, 5068
Contact: Kristen Fragnito         
Australia, Western Australia
GenesisCare Murdoch Recruiting
Murdoch, Western Australia, Australia, 6150
Contact: Joy Vibert         
Georgia
Tbilisi Heart and Vascular Center Recruiting
Tbilisi, Georgia
Contact: George Shaburishvili         
Sponsors and Collaborators
Vascular Dynamics, Inc.
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Responsible Party: Vascular Dynamics, Inc.
ClinicalTrials.gov Identifier: NCT04590001    
Other Study ID Numbers: CRD0593, CRD0594, CRD0595
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vascular Dynamics, Inc.:
Heart Failure
Mobius HD
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases