I50.9
Conditions
Interventions
Group 1: Post-Market-Registerstudie: Patients with an implanted Barostim neo-system in accordance with CE-approved criteria for heart failure with reduced ejection fraction. Data regarding heart failu
Sponsors
CVRx Incorporated
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: To be eligible for this registry, subjects must meet all of the following inclusion criteria: 1. Implanted with the Barostim Neo system per the CE-Mark approved criteria for heart failure at any time in the past. 2. On stable, maximally-tolerated, guideline-directed heart failure medications for at least 30 days prior to implant, where stable is defined as: • No more than a 100% increase or a 50% decrease of the dosage of any one medication other than a diuretic. • Medication changes within a drug class are allowed as long as the equivalent dosage is within the limits specified above. • Unrestricted changes in diuretics are allowed as long as the subject remains on a diuretic. 3. Signed a CVRx-approved informed consent form for the registry.
Exclusion criteria
Exclusion criteria: Patient does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy evaluation will be the following values at six month relative to baseline: a) change in the extent of heart failure (NYHA class) b) Quality of Life as measured by the Minnesota Living with Heart Failure Questionnaire c) assessing the performance of a patient below the anaerobic threshold by using the Six-Minute Hall Walk | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives 1. The following data at 12 months compared to pre-implant baseline: a. Extend of heartfailure measured by NYHA Class b. Quality of Life with the Minnesota Living with Heart failure Questionnaire c. Performance of the patient assed with the Six-Minute Hall Walk d. Biomarker for grade of heart falure (NT-pro-BNP) e. Heartfunction assessed with Left ventricular ejection fraction (LVEF) 2. The rate of all-cause mortality and cardiovascular mortality at 12 months 3. The following data at 12 months compared to to the 12 months period pre-implant: a. Heart failure hospitalization b. Number of episodes c. Total days hospitalized d. Total cost of hospitalization e. Incidence of ventricular and atrial tachyarrhythmias | — |
Countries
Germany
Contacts
Public ContactNicole Baumann
CVRx Incorporated
Outcome results
None listed