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Baroreflex Activation Therapy for Heart Failure

NCT02627196 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1090

Last updated 2026-03-10

Study results available
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Summary

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.

Conditions

Interventions

DEVICE

BAROSTIM NEO® System

DRUG

Medical Management

Sponsors & Collaborators

  • CVRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Zile, MD · Medical University of South Carolina

  • William Abraham, MD · Ohio State University

  • Fred Weaver, MD · University of Southern California

  • Faiez Zannad, MD · Inserm Centre d'Investigation, CHU de Nancy

  • JoAnn Lindenfield, MD · Vanderbilt Heart and Vascular Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-19
Primary Completion
2023-10-31
Completion
2023-10-31
FDA Device
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02627196 on ClinicalTrials.gov