BAROSTIM® Hope for Heart Failure Study (HOPE4HF)

CVRx

Status: Unknown

Conditions: Heart Failure

Treatments: Device: BAROSTIM NEO® System; Other: Standard of care medical managment therapy for heart failure

Study type: Interventional

Funder types: Industry

Identifiers

NCT01720160

360032-001

Details and patient eligibility

About

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).

Full 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 Seventy two subjects were randomized; 32 to the medical management arm and 40 to the device arm (38 implanted, 2 withdrawn).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.

Enrollment: 98 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Device

Experimental group

Description:

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.

Treatment:

Other: Standard of care medical managment therapy for heart failure

Device: BAROSTIM NEO® System

Medical Management

Active Comparator group

Description:

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.

Treatment:

Other: Standard of care medical managment therapy for heart failure