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BAROSTIM® Hope for Heart Failure Study

Not Applicable
Conditions
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 Seventy two subjects were randomized; 32 to the medical management arm and 40 to the device arm (38 implanted, 2 withdrawn).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.

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
Primary Outcome Measures
NameTimeMethod
Heart failure metric improvements from baseline12 months

To describe changes in measures compared to baseline.

System and procedure related adverse events6 months

To demonstrate the safety of the Neo system in a heart failure population.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (23)

Southwest Cardiovascular Associates

🇺🇸

Mesa, Arizona, United States

Arizona Heart Rhythm Research Center

🇺🇸

Phoenix, Arizona, United States

University of Southern California

🇺🇸

Los Angeles, California, United States

George Washington University

🇺🇸

Washington, District of Columbia, United States

ACRC - Cardiology

🇺🇸

Atlantis, Florida, United States

AdventHealth Orlando

🇺🇸

Orlando, Florida, United States

Tampa General Hospital

🇺🇸

Tampa, Florida, United States

Piedmont Heart Institute

🇺🇸

Atlanta, Georgia, United States

Advocate Medical Group

🇺🇸

Naperville, Illinois, United States

Cardiovascular Institute of the South

🇺🇸

Houma, Louisiana, United States

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Southwest Cardiovascular Associates
🇺🇸Mesa, Arizona, United States
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