BAROSTIM NEO ® - Baroreflex Activation Therapy® for Heart Failure
Duration of Study in the UK
3 years, 10 months, 31 days
The purpose of this research is to develop additional, scientific evidence for the safety and effectiveness of Baroreflex Activation Therapy® with the BAROSTIM NEO® System in participants with heart failure, defined as New York Heart Association functional Class III and left ventricular ejection fraction ≤35% despite being treated with the appropriate heart failure guideline recommended therapy, but excluding those eligible for or with an implanted Cardiac Resynchronization Therapy device.
This is a prospective, randomised study. Participants will be randomised 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). The trial will be conducted at up to 90 investigational centres in the U.S. and up to 20 investigational centres outside the U.S. These centres will enrol up to 800 participants to randomise approximately 480 participants who meet the entry criteria. The sample size may increase up to 1,000 randomised participants (or 1,600 enrolled), if deemed necessary after an interim analysis.
East of England - Cambridge East Research Ethics Committee
Date of REC Opinion
8 Jan 2018
Further Information Favourable Opinion