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 : February 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure With Reduced Ejection Fraction||Device: MobiusHD||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Each subject enrolled in the study will undergo implantation of the MobiusHD device.
The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.
- 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.
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
|Contact: Sr. Director, Clinical||(949) email@example.com|
|Contact: Sr. Director, Clinical||(650) firstname.lastname@example.org|
|Bundaberg, Queensland, Australia, 4670|
|Contact: Karen Fox|
|Greenslopes, Queensland, Australia, 4120|
|Contact: Sonia Nelson|
|Australia, South Australia|
|Adelaide, South Australia, Australia, 5068|
|Contact: Kristen Fragnito|
|Australia, Western Australia|
|Murdoch, Western Australia, Australia, 6150|
|Contact: Joy Vibert|
|Tbilisi Heart and Vascular Center||Recruiting|
|Contact: George Shaburishvili|