Heart failure I50
Conditions
Interventions
Group 1: Patients with heart failure and Barostim therapy will be evaluated at baseline / screening, when the device is activated, and at 6 and 12 months after device activation. The following values
Sponsors
CVRx Incorporated
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Inclusion criteria
Inclusion criteria: To be eligible for this study: 1. Signed Ethics Committee (EC) approved informed consent form. 2. Implanted with a de novo BAROSTIM NEO System within 30 days prior to consent, and implant met the CE-Mark approved indications and contraindications for BAROSTIM NEO in the treatment of heart failure: • Indication: New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) = 35% despite being treated with the appropriate heart failure guideline directed therapy. • Contraindications for the implantation of the BAROSTIM NEO o Bilateral carotid bifurcations located above the level of the mandible o Baroreflex failure or autonomic neuropathy o Uncontrolled, symptomatic cardiac bradyarrhythmias o Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50% o Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation 3. BAROSTIM THERAPY has not yet been activated. 4. Age at least 21 years at the time of consent.
Exclusion criteria
Exclusion criteria: If any of the following criteria are met, subjects are not eligible for this study. 1. Received cardiac resynchronization therapy (CRT) within six months of activation, or is actively receiving CRT. 2. Currently have a Class I indication for a cardiac resynchronization therapy (CRT) device according to ESC guidelines for the treatment of congestive heart failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint: To describe the rate of System Related Serious Adverse Events from device activation through the last follow-up visit at 12 months. Primary Efficacy Endpoint - LVESVi: To determine whether the BAROSTIM THERAPY produces a change in Left Ventricular End Systolic Volume Index (LVESVi) from baseline through 6 months of follow-up in subject implanted with the BAROSTIM NEO System. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether the BAROSTIM THERAPY produces a change in Left Ventricular Ejection Fraction (LVEF) from baseline through 6 months of follow-up in subject implanted with the BAROSTIM NEO System. | — |
Countries
Germany
Contacts
Public ContactNicole Baumann
CVRx Inc.
Outcome results
None listed