We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    mobiusHD | heart failure
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04590001
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : May 11, 2023
Sponsor:
Information provided by (Responsible Party):
Vascular Dynamics, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: 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.

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

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

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Lisa Director, Clinical Operations (949) 231-7602 lgreen@vasculardynamics.com

Locations
Layout table for location information
Australia, Sydney
St. Vincent's Hospital Recruiting
Darlinghurst, Sydney, Australia, NSW 2010
Contact: Erika O'Dea       erika.odea@svha.org.au   
Principal Investigator: David Muller, MD         
Australia, Western Australia
Fiona Stanley Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
Contact: Gillian Tulloch       gillian.tulloch@health.wa.gov.au   
Principal Investigator: Amit Shah, MD         
Canada, Ontario
London Health Science Center Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Heather Hern    5196858500    heather.hern@lhsc.on.ca   
Principal Investigator: Stuart Smith, MD         
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Helene Brown       helene.brown@icm-mhi.org   
Principal Investigator: Anique Ducharme, MD         
Georgia
Helsicore Ltd "Israeli-Georgian Medical Research Clinic Helsicore" Recruiting
Tbilisi, Georgia
Contact: Anna Bekaia         
Tbilisi Heart and Vascular Center Recruiting
Tbilisi, Georgia
Contact: George Shaburishvili         
Germany
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany
Contact: Katharina Gille       katharina.gille@dhzc-charite.de   
Principal Investigator: Mohammad Sherif, Prof. dr. med         
Heart Center, University Hospital Dresden Recruiting
Dresden, Germany
Contact: Cecile Bosredon       cecile.bosredon1@tu-dresden.de   
Principal Investigator: Axel Linke, Prof. dr. med         
CardioVascular Center - CVC Frankfurt Recruiting
Frankfurt, Germany
Contact: Stefanie Schlimm       s.schlimm@cvcfrankfurt.de   
Principal Investigator: Horst Sievert, Prof. dr. med         
Justus-Liebig-Universitat Giessen Recruiting
Gießen, Germany
Contact: Anne Drewenka       anne.drewenka@innere.med.uni-giessen.de   
Principal Investigator: Christian Hamm, Prof. dr med         
University of Saarlandes - Homburg Recruiting
Homburg, Germany
Contact: Christina Koch       christina.koch@uks.edu   
Principal Investigator: Felix Mahfoud, Prof. dr. med         
Krankenhaus der Barmherzigen Brüder Trier Recruiting
Trier, Germany
Contact: Hannah Waschbuesch       h.waschbuesch@bbtgruppe.de   
Principal Investigator: Jurgen Leick, Dr. med         
Sponsors and Collaborators
Vascular Dynamics, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Vascular Dynamics, Inc.
ClinicalTrials.gov Identifier: NCT04590001    
Other Study ID Numbers: CRD0593, 0594, 0595, 0596
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: May 11, 2023
Last Verified: May 2023

Layout table for additional information
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:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases