Clinical trialNCT02627196CompletedInterventional

Baroreflex Activation Therapy for Heart Failure

SponsorCVRx, Inc.Enrollment1,090Heart Failure

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Faiez Zannad, MD
Inserm Centre d'Investigation, CHU de Nancy
Principal Investigator
clinicaltrials.gov ↗
Fred Weaver, MD
University of Southern California
Principal Investigator
clinicaltrials.gov ↗
JoAnn Lindenfield, MD
Vanderbilt Heart and Vascular Institute
Principal Investigator
clinicaltrials.gov ↗
Michael Zile, MD
Medical University of South Carolina
Study ChairKOL profile →
clinicaltrials.gov ↗
William Abraham, MD
Ohio State University
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

92 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United Kingdom

Royal Papworth Hospital Nhs Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, Merseyside, United Kingdom
Royal Brompton & Harefield Nhs Foundation Trust
Harefield, Middlesex, United Kingdom
Belfast Health & Social Care Trust
Belfast, Northern Ireland, United Kingdom

United States

Heart and Rhythm Solutions, Pllc
Chandler, Arizona, United States
Chan Heart Rhythm Institute
Mesa, Arizona, United States
Arizona Arrhythmia Research Center
Phoenix, Arizona, United States
Cardiovascular Consultants, Ltd.
Phoenix, Arizona, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Washington Regional Medical Center
Fayetteville, Arkansas, United States
Central Cardiology Medical Center
Bakersfield, California, United States
Chula Vista Cardiac Center
Chula Vista, California, United States
Sharp Chula Vista Medical Center
Chula Vista, California, United States
Sharp Grossmont
Chula Vista, California, United States
John Muir Health Clinical Research Center
Concord, California, United States
Herndon Surgery Center
Fresno, California, United States
University of California, San Francisco - Fresno
Fresno, California, United States
Glendale Adventist Medical Center
Glendale, California, United States
Memorial Health Services
Laguna Hills, California, United States
Los Alamitos Cardiovascular
Los Alamitos, California, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
Advanced Cardiovascular Specialists
Mountain View, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
Uc Irvine Health
Orange, California, United States
Desert Heart Regional Medical Center
Palm Springs, California, United States
Huntington Hospital
Pasadena, California, United States
Dignity Health
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
Bonometti, Inc
Santa Barbara, California, United States
Adventist Heart Institute
St. Helena, California, United States
North Colorado Medical Center
Greeley, Colorado, United States
Medical Center of the Rockies Research
Loveland, Colorado, United States
Atlantic Clinical Research Center - Cardiology
Atlantis, Florida, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Memorial Cardiovascular Institute
Hollywood, Florida, United States
Adventhealth Orlando
Orlando, Florida, United States
Avanza Medical Research Center
Pensacola, Florida, United States
University of South Florida
Tampa, Florida, United States

52 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Medical Management

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 19 Apr 2016
Primary completion: 31 Oct 2023
Completion: 31 Oct 2023
Last update posted: 10 Mar 2026
Registered enrollment: 1,090
Registry id: NCT02627196

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.