Beat HF

Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure

Beat HF [NCT02627196]

Description:   The Barostim Neo - Baroreflex Activation Therapy for Heart Failure is a prospective, randomized trial in subjects with reduced ejection fraction heart failure.

Device:  Barostim Neo System

Primary Investigator: O'brien

Drug/Device Information
Barostim Neo System
To develop valid scientific evidence for safety and effectiveness of baroreflex activation therapy (BAT) with the Barostim neo system in subjects with heart failure
The CVRx Barostim Neo system resembles a pacemaker system, consisting of a pulse generator implanted in the pectoral region of the chest and a carotid sinus lead
BAT reduces afterload, consequently reducing filling pressures, and left atrial size
Randomized in a 1:1 ratio to receive Barostim activation therapy with an implanted Barostim neo system in addition to medical management or to receive medical management alone (no device implant)
CVRx, INC
Major Inclusion and Exclusion
Age 21 years or above
Chronic NYHA Class III
Left ventricular ejection fraction ≤ 35%
BNP ≥ 400 or BNP ≤ 100 and prior hospitalization for heart failure within 12 months
On optimal, stable, guideline directed medical (per the AHA/ACC guidelines) for the treatment of heart-failure for at least 4 weeks
Six-minute hall walk ≥ 150 m and ≤ 400 m
No implanted cardiac resynchronization therapy (CRT) device
No prior surgery, radiation, or endovascular stent placement in either carotid artery or the carotid sinus region
No eGFR < 30 mL/min/1.73 m2
No two independent measures of resting heart rate of either < 60 bpm or > 100 bpm or systolic blood pressure < 100 mmHg
No severe COPD or severe restrictive lung disease (e.g. requires chronic steroid use or home oxygen use)