BATwire Implant Kit

NCT04600791 | Terminated DMC FDA Device

• 1 other identifier: 360058-001
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 10

Brief 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. 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Freedom from 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.

  30 days post-implant

• Six Minute Hall Walk (6MHW)

  To demonstrate that treatment with the Barostim System implanted using the BATwire Implant Kit results in an improvement in 6MHW at 6 months.

  6 months post implant

Study Arms (1)

BATwire Kit

EXPERIMENTAL

Subjects will be implanted using the BATwire Implant Kit

Device: BATwire Implant Kit

Interventions

BATwire Implant Kit DEVICE

The BATwire Implant Kit is a delivery system for the placement of the Barostim Carotid Sinus Lead.

BATwire Kit

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• CVRx, Inc.: lead

Study Sites (10)

Chan Heart Rhythm Institute

Mesa, Arizona, 85206, United States

Location

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

AdventHealth

Orlando, Florida, 32803, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

Piedmont Health

Atlanta, Georgia, 30309, United States

Location

St. Louis Heart and Vascular, P.C.

St Louis, Missouri, 63136, United States

Location

Cone Health

Greensboro, North Carolina, 27401, United States

Location

Wake Forest

Winston-Salem, North Carolina, 27157, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bradley Knight, MD

  Northwestern University

  STUDY CHAIR

• Michael Zile, MD

  Medical University of South Carolina

  STUDY CHAIR

• Fred Weaver, MD

  University of Southern California

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: January 29, 2021
• Primary Completion: August 28, 2024
• Study Completion: February 17, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)