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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.

Tracking Information
First Submitted Date  ICMJE October 5, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date February 9, 2021
Actual Study Start Date  ICMJE October 2, 2020
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2021)
  • 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
  • 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
  • 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.
  • 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
  • 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.
  • 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.
  • Adverse Events [ Time Frame: 24 months ]
    Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events
  • Cardiovascular Mortality [ Time Frame: 24 months ]
    Rate of cardiovascular mortality throughout the follow-up period will be reported.
  • Heart Failure Hospitalizations [ Time Frame: 24 months ]
    Rate of heart failure hospitalizations throughout the follow-up period will be reported.
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2020)
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2020)
  • 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
  • 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
  • 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
  • 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.
  • Adverse Events [ Time Frame: 24 months ]
    Incidence and severity of adverse events and serious adverse events, including serious adverse cardiovascular and neurological events
  • Cardiovascular Mortality [ Time Frame: 24 months ]
    Rate of cardiovascular mortality throughout the follow-up period will be reported.
  • Heart Failure Hospitalizations [ Time Frame: 24 months ]
    Rate of heart failure hospitalizations throughout the follow-up period will be reported.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of the MobiusHD® in Patients With Heart Failure
Official Title  ICMJE 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure With Reduced Ejection Fraction
Intervention  ICMJE Device: MobiusHD
The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.
Study Arms  ICMJE Experimental: MobiusHD
Each subject enrolled in the study will undergo implantation of the MobiusHD device.
Intervention: Device: MobiusHD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 23, 2020)
40
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2020)
20
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sr. Director, Clinical (949) 942-1640 rnangia@vasculardynamics.com
Contact: Sr. Director, Clinical (650) 208-1118 tshipman@vasculardynamics.com
Listed Location Countries  ICMJE Australia,   Georgia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04590001
Other Study ID Numbers  ICMJE CRD0593, CRD0594, CRD0595
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vascular Dynamics, Inc.
Study Sponsor  ICMJE Vascular Dynamics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vascular Dynamics, Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP