Heart FailureNCT04600791
BATwire Implant Kit Study
A study testing BATwire Implant Kit in people with Heart Failure, run by CVRx, Inc. at 10 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- BATwire Implant Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 10 sitesUnited States
- Study dates
- 29 Jan 2021to 17 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 21 years and no more than 80 years at the time of enrollment.
- Appropriate candidate for the surgery as determined by an evaluation from the implanting physician using a carotid duplex ultrasound (CDU) and/or a computed tomography angiography (CTA), and a review of medical history (including existence of infections that may increase implant risk). Evaluation must confirm the following within 45 days of the Barostim implant (60 days allowed if a proctor is required):
- Appropriate medical condition and medical history for implantation of the Barostim System AND
- Anatomy that enables this implant procedure, with no vascular structures or orientations or neck anomalies that would be obstructive to the implantation path AND
- The artery planned for the Barostim implant must have:
- A carotid bifurcation below the level of the mandible AND
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- No ulcerative carotid arterial plaques AND
- No carotid atherosclerosis producing a 30% or greater reduction in linear diameter in the internal carotid AND
- No carotid atherosclerosis producing a 30% or greater reduction in linear diameter in the distal common carotid AND
- Have had no prior surgery, radiation, or endovascular stent placement in the carotid artery or the carotid sinus region AND
- Able to discontinue the use of antiplatelet drugs (e.g., aspirin) in advance of the procedure, if required.
- Six-minute hall walk (6MHW) ≥ 150 m AND ≤ 400 m within 45 days prior to implant (60 days allowed if a proctor is required).
- Serum estimated glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m^2 using the CKD-EPI method within 45 days prior to the Barostim implant (60 days allowed if a proctor is required).
- Body mass index ≤ 40 kg/m^2 within 45 days prior to the Barostim implant (60 days allowed if a proctor is required).
- If female and of childbearing potential, must use a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) and agree to continue use of this method for the duration of the study. Women of childbearing potential must have a negative pregnancy test within 14 days prior to the Barostim implant.
- Subjects implanted with a cardiac rhythm management device that does not utilize an intracardiac lead, or implanted with a neurostimulation device, must be approved by the CVRx Clinical department.
- At the end of screening and baseline, the subject still meets the Barostim Indication for Use
- Signed a CVRx-approved informed consent form for participation in this study.
Who cannot join
- Received cardiac resynchronization therapy (CRT) within six months of enrollment, or is actively receiving CRT.
- Any of the following contraindications:
- Baroreflex failure or autonomic neuropathy
- Uncontrolled, symptomatic cardiac bradyarrhythmias
- Known allergy to silicone or titanium
- Unstable ventricular arrhythmias.
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- Presence of baseline cranial nerve dysfunction at risk from cervical interventions on the carotid bifurcation determined by the Ear, Nose and Throat (ENT) examination.
- Subjects with any surgery that has occurred, or is planned to occur, within 45 days of the Barostim implant.
- Recent history (within 6 months of implant) of significant and uncontrolled bleeding.
- Known and untreated hypercoagulability state.
- An inappropriate study candidate as evidenced by:
- Solid organ or hematologic transplant, or currently being evaluated for an organ transplant.
- Has received or is receiving LVAD therapy or chronic dialysis.
- Current or planned treatment with intravenous positive inotrope therapy.
- Primary pulmonary hypertension.
- Severe COPD or severe restrictive lung disease (e.g., requires chronic oral steroid use or home oxygen use).
- Heart failure secondary to a reversible cause, such as cardiac structural valvular disease, acute myocarditis and pericardial constriction.
- Clinically significant cardiac structural valvular disease.
- Unable or unwilling to fulfill the protocol medication compliance and follow-up requirements, for reasons including but not limited to an unresolved history of alcohol or substance abuse or psychiatric disorder.
- Active malignancy.
- Any other serious medical condition that may adversely affect the safety of the participant or validity of the study, in the opinion of the investigator.
- Life expectancy less than one year.
- Any of the following within 3 months prior to the Barostim implant.
- Myocardial infarction
- Unstable angina
- Percutaneous coronary intervention (e.g., CABG or PTCA)
- Cerebral vascular accident or transient ischemic attack
- Sudden cardiac death
- Surgical cardiac intervention (e.g., cardiac ablation, valve replacement)
- Enrolled and active in another (e.g., device, pharmaceutical, or biological) clinical study unless approved by the CVRx Clinical department.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory University
Atlanta, Georgia, 30308
Piedmont Health
Atlanta, Georgia, 30309
Austin Heart
Austin, Texas, 78756
Medical University of South Carolina
Charleston, South Carolina, 29425
Cone Health
Greensboro, North Carolina, 27401
Chan Heart Rhythm Institute
Mesa, Arizona, 85206
AdventHealth
Orlando, Florida, 32803
HonorHealth
Scottsdale, Arizona, 85258
St. Louis Heart and Vascular, P.C.
St Louis, Missouri, 63136
Wake Forest
Winston-Salem, North Carolina, 27157
About this study
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.
Read the detailed description
The BATwire Implant Kit Study is a prospective study of up to 400 subjects enrolled at up to 35 U.S. sites. Up to 100 subjects will be implanted with the Barostim System using the BATwire Kit after all screening is complete and all enrollment criteria are met. The study will evaluate the implant experience, safety and effectiveness of the BATwire kit.
All subjects will be implanted, and the device will be activated prior to being discharged. Follow-up visits will occur at 0.5, 1, 2, 3, 6 and 12 months post implant. Once the 12-month visit has been completed, the subject is withdrawn from the study and followed in a commercial setting.
- Conditions
- Heart Failure
- Being tested
- BATwire Implant Kit
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BATwire Implant KitDevice
The BATwire Implant Kit is a delivery system for the placement of the Barostim Carotid Sinus Lead.
| Study group | Role | What they receive |
|---|---|---|
| BATwire Kit | Experimental | Subjects will be implanted using the BATwire Implant Kit Receives: Device: BATwire Implant Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Without Serious Adverse Events (SAEs) Related to the Implantation of the Lead Using the BATwire Implant Kit Through 30 Days Post-implant.
To demonstrate the safety of implanting the Barostim lead using the BATwire Implant Kit using all serious adverse events that are related to the BATwire lead implantation that occur between implant, or attempted implant, and 30 days post implant.
Measured: 30 days post-implant
Change in Six Minute Hall Walk (6MHW) Distance Walked
To demonstrate that treatment with the Barostim System implanted using the BATwire Implant Kit results in an improvement in 6MHW at 6 months.
Measured: From baseline to 6 months of follow-up, post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start29 Jan 2021
- Primary completion28 Aug 2024
- Study completion17 Feb 2025
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- CVRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bradley Knight, MD, Study chair, Northwestern UniversityMichael Zile, MD, Study chair, Medical University of South CarolinaFred Weaver, MD, Study chair, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600791
- Sponsor's protocol ID
- 360058-001
- Status last verified
- May 2025
- First submitted
- 19 Oct 2020
- Last updated
- 1 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BATwire Implant Kit Study
- ClinicalTrials.gov ID
- NCT04600791
- Acronym / sponsor ID
- 360058-001
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 93 participants (actual)
- Lead sponsor
- CVRx, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Posted 1 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The BATwire Implant Kit Study is a prospective study of up to 400 subjects enrolled at up to 35 U.S. sites. Up to 100 subjects will be implanted with the Barostim System using the BATwire Kit after all screening is complete and all enrollment criteria are met. The study will evaluate the implant experience, safety and effectiveness of the BATwire kit.
All subjects will be implanted, and the device will be activated prior to being discharged. Follow-up visits will occur at 0.5, 1, 2, 3, 6 and 12 months post implant. Once the 12-month visit has been completed, the subject is withdrawn from the study and followed in a commercial setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BATwire Kit | Experimental | Device: BATwire Implant KitSubjects will be implanted using the BATwire Implant Kit |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age at least 21 years and no more than 80 years at the time of enrollment.
- Appropriate candidate for the surgery as determined by an evaluation from the implanting physician using a carotid duplex ultrasound (CDU) and/or a computed tomography angiography (CTA), and a review of medical history (including existence of infections that may increase implant risk). Evaluation must confirm the following within 45 days of the Barostim implant (60 days allowed if a proctor is required):
- Six-minute hall walk (6MHW) ≥ 150 m AND ≤ 400 m within 45 days prior to implant (60 days allowed if a proctor is required).
- Serum estimated glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m^2 using the CKD-EPI method within 45 days prior to the Barostim implant (60 days allowed if a proctor is required).
- Body mass index ≤ 40 kg/m^2 within 45 days prior to the Barostim implant (60 days allowed if a proctor is required).
Key exclusion criteria (30 listed)
- Received cardiac resynchronization therapy (CRT) within six months of enrollment, or is actively receiving CRT.
- Any of the following contraindications:
- Unstable ventricular arrhythmias.
- Presence of baseline cranial nerve dysfunction at risk from cervical interventions on the carotid bifurcation determined by the Ear, Nose and Throat (ENT) examination.
- Subjects with any surgery that has occurred, or is planned to occur, within 45 days of the Barostim implant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BATwire Implant KitThe BATwire Implant Kit is a delivery system for the placement of the Barostim Carotid Sinus Lead. | Device | BATwire Kit |
Primary outcome
Number of Participants Without Serious Adverse Events (SAEs) Related to the Implantation of the Lead Using the BATwire Implant Kit Through 30 Days Post-implant.
Time frame: 30 days post-implant
To demonstrate the safety of implanting the Barostim lead using the BATwire Implant Kit using all serious adverse events that are related to the BATwire lead implantation that occur between implant, or attempted implant, and 30 days post implant.
Change in Six Minute Hall Walk (6MHW) Distance Walked
Time frame: From baseline to 6 months of follow-up, post-implant
To demonstrate that treatment with the Barostim System implanted using the BATwire Implant Kit results in an improvement in 6MHW at 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Knight, MD study chair
Northwestern University
Michael Zile, MD study chair
Medical University of South Carolina
Fred Weaver, MD study chair
University of Southern California
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BATwire Implant Kit in people with Heart Failure, run by CVRx, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Without Serious Adverse Events (SAEs) Related to the Implantation of the Lead Using the BATwire Implant Kit Through 30 Days Post-implant. (time frame: 30 days post-implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.