Last updated on August 2019

Baroreflex Activation Therapy for Heart Failure


Brief description of study

The purpose of this clinical trial (NCT02627196) is to develop valid scientific evidence for safety and effectiveness of Baroreflex Activation Therapy with the BAROSTIM NEO System in subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III, left ventricular ejection fraction (LVEF) 35% and NT-proBNP<1600 pg/ml despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or actively receiving Cardiac Resynchronization Therapy (CRT).

The total trial duration is anticipated to be approximately 5 years; however, the duration of an individual subject enrollment will depend on when he or she entered the trial.

Detailed Study Description

The BAROSTIM NEO - Baroreflex Activation Therapy for Heart Failure is a prospective, randomized trial in subjects with reduced ejection fraction heart failure. Subjects will be randomized in a 1:1 ratio to receive Barostim Activation Therapy with an implanted BAROSTIM NEO System in addition to medical management or to receive medical management alone (no device implant). The trial will be conducted at up to 120 investigational centers in the U.S. and up to 20 investigational centers outside the U.S. These centers will enroll up to 1200 subjects to randomize approximately 480 subjects who meet the entry criteria.

For all subjects, trial visits will occur at 0.5, 1, 1.5, 2, 3, 6, 9 and 12 months post-implant (post anticipated implant for medical management). Visits will occur quarterly from 15 to 24 months and semi-annually thereafter.

Subjects are followed in an identical manner regardless of trial arm.

The data will provide evidence of the safety and efficacy of BAROSTIM THERAPY. The accumulated morbidity and mortality data collected will provide evidence of morbidity and mortality benefit. This trial will involve one or more interim analyses to evaluate when sufficient evidence is reached for the final morbidity and mortality analysis.

Clinical Study Identifier: NCT02627196

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St. Louis Heart and Vascular

Saint Louis, MO United States
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Mercer University

Macon, GA United States
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Norton Heart Specialist

Louisville, KY United States
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Presbyterian Heart Group

Albuquerque, NM United States
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Mercy Hospital St. Louis

Saint Louis, MO United States
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Central Cardiology Medical Center

Bakersfield, CA United States
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Holy Cross Hospital

Fort Lauderdale, FL United States
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Providence Park Hospital

Southfield, MI United States
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Cone Health

Greensboro, NC United States
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Adventist Heart Institute

Saint Helena, CA United States
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University of Kansas

Kansas City, KS United States
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Private Practice Leadership

Houston, TX United States
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Avanza Medical Research Center

Pensacola, FL United States
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Herndon Surgery Center

Fresno, CA United States
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UC Irvine Health

Orange, CA United States
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Wake Forest Baptist Health

Winston-Salem, NC United States
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Washington Regional Medical Center

Fayetteville, AR United States
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University of Utah

Salt Lake City, UT United States
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Washington University

Saint Louis, MO United States
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Huntington Hospital

Pasadena, CA United States
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Virginia Mason

Seattle, WA United States
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Florida Hospital

Orlando, FL United States
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Hoag Memorial Hospital

Newport Beach, CA United States
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WakeMed

Raleigh, NC United States
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The Christ Hospital

Cincinnati, OH United States
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Ohio State University

Columbus, OH United States
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Chula Vista Cardiac Center

Chula Vista, CA United States
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Bonometti, Inc

Santa Barbara, CA United States
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Stern Cardiovascular Foundation

Germantown, TN United States
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Mercy Hospital Springfeild

Springfield, MO United States
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UP Health System Marquette

Marquette, MI United States
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Lancaster General Hospital

Lancaster, PA United States
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Via Christi

Wichita, KS United States
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Deborah Heart and Lung Center

Browns Mills, NJ United States
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Dignity Health

Sacramento, CA United States
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Los Alamitos Cardiovascular

Los Alamitos, CA United States
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Sharp Grossmont

Chula Vista, CA United States
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Baptist Health Lexington

Lexington, KY United States
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Memorial Health Services

Laguna Hills, CA United States
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Columbia St. Mary's Hospital

Milwaukee, WI United States
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University of Southern California

Los Angeles, CA United States
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WellStar Medical Group

Marietta, GA United States
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Nebraska Heart Institute

Lincoln, NE United States
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Advocate Medical Group

Naperville, IL United States
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Tulane University

New Orleans, LA United States
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Drexel University

Philadelphia, PA United States
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Queens Medical Center

Honolulu, HI United States
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University of Kentucky

Lexington, KY United States
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Sharp Chula Vista Medical Center

Chula Vista, CA United States
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Advanced Cardiovascular Specialists

Mountain View, CA United States
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George Washington University

Washington, WA United States
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AdventHealth Orlando

Orlando, FL United States
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Carle Foundation Hospital

Urbana, IL United States
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The Heart Group - Deaconess

Newburgh, IN United States
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Via Christi Research

Wichita, KS United States
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Ochsner Clinic Foundation

New Orleans, LA United States
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Mercy Hospital Springfield

Springfield, MO United States
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Bryan Heart

Lincoln, NE United States
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New York Presbytarian/Queens

Flushing, NY United States
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University of Rochester

Rochester, NY United States
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McLeod Cardiology Associates

Florence, SC United States
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