BAROSTIM® Hope for Heart Failure Study (HOPE4HF)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Systolic Heart Failure, Congestive Heart Failure, Reduced left ventricular ejection fraction, HFrEF
Eligibility Criteria
Inclusion Criteria:
- Actively participating in the BAROSTIM HOPE4HF Study and currently implanted with the BAROSTIM NEO device with the device turned ON.
- Have signed a revised approved informed consent form for continued participation in this study.
Exclusion Criteria:
• Treating physician decision that the subject should not continue with therapy.
Sites / Locations
- Southwest Cardiovascular Associates
- Arizona Heart Rhythm Research Center
- University of Southern California
- George Washington University
- ACRC - Cardiology
- AdventHealth Orlando
- Tampa General Hospital
- Piedmont Heart Institute
- Advocate Medical Group
- Cardiovascular Institute of the South
- St Elizabeth's Medical Center
- Mid-Michigan Medical Center Midland
- Cardiac & Vascular Research Center of Northern Michigan
- University of Mississippi Medical Center
- University Medical Center of Southern Nevada
- Hackensack University Medical Center
- The Ohio State University
- Oklahoma Cardiovascular Research Group
- Drexel University College of Medicine
- Allegheny General Hospital
- Lonestar Heart Center
- Wheaton Franciscan Healthcare
- Aspirus Heart & Vascular Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Device
Medical Management
1) BAROSTIM NEO System and 2) standard of care medical management therapy for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Standard of care medical management therapy for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.