NCT01720160

BAROSTIM® Hope for Heart Failure Study

Barostim HOPE4HF Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: CVRx, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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 Seventy two subjects were randomized; 32 to the medical management arm and 40 to the device arm (38 implanted, 2 withdrawn).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

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	BAROSTIM NEO® System	Implant procedure
OTHER	Standard of care medical managment therapy for heart failure	Standard of care medical management therapy for heart failure (AHA/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.

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-05-01
• Completion: 2021-03-01
• First posted: 2012-11-02
• Last updated: 2019-05-14

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated device study