Thank you for your interest in participating in the BeAT-HF Clinical Trial by CVRx Inc.
The BeAT-HF Clinical Trial is evaluating the investigational BAROSTIM NEO implantable device, designed to electrically stimulate the baroreceptors located on one of the carotid arteries in your neck. This may result in improved heart function and reduced heart failure symptoms. This device is not a defibrillator or a pacemaker, it is a different technology. People implanted with a defibrillator and/or a pacemaker may be potential candidates for the Trial and may use these devices simultaneously.
Ask yourself the following 5 questions…
1. Has a medical doctor diagnosed you with heart failure?
2. Are you taking medications prescribed by your doctor to treat your heart failure symptoms?
3. Despite taking the medications prescribed by your doctor, does chronic fatigue and breathlessness prevent you from performing activities like going on a walk, playing with your grandchildren or going up the stairs?
4. Have you been to the emergency room or been hospitalized for breathlessness due to fluid in the lungs in the last 12 months?
5. Do you have an ejection fraction (a measure of heart pumping efficiency) of 35% or less?
If you said yes to a majority of these 5 questions, you may be a potential candidate to participate in the BeAT-HF Clinical Trial.
IMPORTANT FACTS: The BeAT Heart Failure Study (BeAT-HF) evaluates an investigational implantable device. The Study has been approved by the FDA and is designated as an FDA Breakthrough Devices Program due to its potential as a therapy to treat a life-threatening disease with no approved alternative treatment. The Study is registered on www.ClinicalTrials.gov, a service of the National Institues of Health (NIH).