BAROSTIM® Hope for Heart Failure Study

Not Applicable

• Conditions: Heart Failure
• Interventions: Device: BAROSTIM NEO® System; Other: Standard of care medical managment therapy for heart failure

• Registration Number: NCT01720160
• Lead Sponsor: CVRx, Inc.

Brief Summary

The purpose of this clinical investigation is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM® HOPE4HF Trial (NCT01720160).

Detailed Description

A prospective, randomized study describing the safety and efficacy of the BAROSTIM NEO System in heart failure subjects with left ventricular ejection fraction equal to or less than 35 percent. Seventy two subjects were randomized; 32 to the medical management arm and 40 to the device arm (38 implanted, 2 withdrawn). The study closed to new enrollments on January 31, 2014. Subjects are in long-term follow-up and are required to have at least one annual visit. During the visit, there will be a physical assessment, a review of medications and serious adverse events.

Study Timeline

• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-31
• Study Start: 2012-11
• Study First Posted: 2012-11-02
• Primary Completion: 2015-05
• Disposition First Submitted: 2016-08-30
• Disposition First Submitted QC: 2016-08-30
• Disposition First Posted: 2016-09-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-08
• Last Update Posted: 2019-05-14
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device	BAROSTIM NEO® System	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.
Device	Standard of care medical managment therapy for heart failure	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.
Medical Management	Standard of care medical managment therapy for heart failure	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.

Primary Outcome Measures

Name	Time	Method
Heart failure metric improvements from baseline	12 months	To describe changes in measures compared to baseline.
System and procedure related adverse events	6 months	To demonstrate the safety of the Neo system in a heart failure population.

Trial Locations

Locations (23)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Drexel University College of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States

Southwest Cardiovascular Associates; 🇺🇸 Mesa, Arizona, United States

Cardiac & Vascular Research Center of Northern Michigan; 🇺🇸 Petoskey, Michigan, United States

Wheaton Franciscan Healthcare; 🇺🇸 Milwaukee, Wisconsin, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Arizona Heart Rhythm Research Center; 🇺🇸 Phoenix, Arizona, United States

Cardiovascular Institute of the South; 🇺🇸 Houma, Louisiana, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States

Advocate Medical Group; 🇺🇸 Naperville, Illinois, United States

St Elizabeth's Medical Center; 🇺🇸 Brighton, Massachusetts, United States

University Medical Center of Southern Nevada; 🇺🇸 Las Vegas, Nevada, United States

ACRC - Cardiology; 🇺🇸 Atlantis, Florida, United States

Lonestar Heart Center; 🇺🇸 Amarillo, Texas, United States

Aspirus Heart & Vascular Institute; 🇺🇸 Wausau, Wisconsin, United States

Oklahoma Cardiovascular Research Group; 🇺🇸 Oklahoma City, Oklahoma, United States

Mid-Michigan Medical Center Midland; 🇺🇸 Midland, Michigan, United States