Barostim Therapy™ in Heart Failure with Preserved Ejection Fraction (HFrEF): A Data Collection Registry with the CE-Marked Barostim neo™ System
- Conditions
- I50.9Heart failure, unspecified
- Registration Number
- DRKS00009443
- Lead Sponsor
- CVRx Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
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.
Patient does not meet inclusion criteria
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy evaluation will be the following values at six month relative to baseline:<br><br>a) change in the extent of heart failure (NYHA class)<br>b) Quality of Life as measured by the Minnesota Living with Heart Failure Questionnaire<br>c) assessing the performance of a patient below the anaerobic threshold by using the Six-Minute Hall Walk
- Secondary Outcome Measures
Name Time Method Secondary Objectives<br>1. The following data at 12 months compared to pre-implant baseline:<br>a. Extend of heartfailure measured by NYHA Class<br>b. Quality of Life with the Minnesota Living with Heart failure Questionnaire<br>c. Performance of the patient assed with the Six-Minute Hall Walk<br>d. Biomarker for grade of heart falure (NT-pro-BNP)<br>e. Heartfunction assessed with Left ventricular ejection fraction (LVEF)<br>2. The rate of all-cause mortality and cardiovascular mortality at 12 months<br>3. The following data at 12 months compared to to the 12 months period pre-implant:<br>a. Heart failure hospitalization<br>b. Number of episodes<br>c. Total days hospitalized<br>d. Total cost of hospitalization<br>e. Incidence of ventricular and atrial tachyarrhythmias