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Terminated Not applicable Interventional Results available

BATwire Implant Kit Study

ClinicalTrials.gov ID: NCT04600791

Public ClinicalTrials.gov record NCT04600791. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 3:08 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this clinical investigation is to develop valid scientific evidence for the safety and effectiveness of the Barostim System delivered by the BATwire Implant Kit (BATwire Kit) in subjects with heart failure. Subjects may be enrolled if they meet the FDA approved PMA indication for use for the Barostim NEO or Barostim NEO2 device: Subjects who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP \< 1600 pg/ml and excludes patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.

Study identification

NCT ID
NCT04600791
Recruitment status
Terminated
Study type
Interventional
Phase
Not applicable
Lead sponsor
CVRx, Inc.
Industry
Enrollment
93 participants

Conditions and interventions

Conditions

Interventions

Device

Eligibility (public fields only)

Age range
21 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 29, 2021 (Actual)
Primary completion
Aug 28, 2024 (Actual)
Completion
Feb 17, 2025 (Actual)
Last update posted
Oct 1, 2026

2021 – 2025

United States locations

U.S. sites
10
U.S. states
7
U.S. cities
9
Facility City State ZIP Site status
Chan Heart Rhythm Institute Mesa Arizona 85206 —
HonorHealth Scottsdale Arizona 85258 —
AdventHealth Orlando Florida 32803 —
Emory University Atlanta Georgia 30308 —
Piedmont Health Atlanta Georgia 30309 —
St. Louis Heart and Vascular, P.C. St Louis Missouri 63136 —
Cone Health Greensboro North Carolina 27401 —
Wake Forest Winston-Salem North Carolina 27157 —
Medical University of South Carolina Charleston South Carolina 29425 —
Austin Heart Austin Texas 78756 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04600791, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 1, 2026 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04600791 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →