I50.9
Conditions
Interventions
Group 1: Post-market registry study in patients with Barostim therapy and preserved ejection fraction: heart failure and device data will be collected after 3 and 6 months, which are compared with the
Sponsors
CVRx Incorporated
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: g inclusion criteria: 1. Implanted with the Barostim Neo system in accordance with CE-Mark approved criteria for resistant hypertension, within 14 days prior to enrollment. 2. No ongoing adverse events related to the Barostim Neo implant procedure. 3. Barostim Therapy not yet chronically activated. 4. Pre-implant echocardiogram with left ventricular ejection fraction = 50% within 1 month prior to enrollment. 5. On stable, maximally-tolerated, guideline-directed hypertension/heart failure medications for at least 30 days prior to enrollment. 6. Objective evidence of heart failure according to the following criteria: • Hospitalization for heart failure within 12 months prior to enrollment OR • Echocardiographic evidence of diastolic dysfunction (LA Volume Index >34 ml/m2 OR E/e >13) within 1 month prior to enrollment OR • NTproBNP > 220 pg/mL or BNP > 80 pg/mL (in atrial fibrillation, NTproBNP > 600 pg/mL or BNP > 200 pg/mL) within 1 month prior to enrollment 7. Signed a CVRx-approved informed consent form for the registry.
Exclusion criteria
Exclusion criteria: 1. Heart failure secondary to a reversible or treatable condition such as, cardiac structural valvular disease, acute myocarditis and pericardial constriction. 2. Heart failure secondary to right ventricular failure or right ventricular myocardial infarction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe change in office cuff systolic blood pressure at 6 months compared to pre-implant baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe changes in the following measures at 6 months compared to pre-implant baseline: • Left ventricular mass index • LA volume index • E/E’ ratio • Other echocardiographic measures To describe changes in the following measures at 6 months compared to pre-activation baseline: • NYHA Class • NT-pro-BNP, as routinely collected as standard of care • Other biomarkers of end organ damage routinely collected as standard of care (e.g., eGFR, Troponin T, etc.) | — |
Countries
Germany
Contacts
Public ContactNicole Baumann
CVRx Incorporated
Outcome results
None listed