BATwire Implant Kit

Study Overview
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Brief Summary
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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
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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 Once the 12-month visit has been completed, the subject is withdrawn from the study and followed in a commercial setting.

Official Title
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BATwire Implant Kit

Conditions
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Heart Failure

Intervention / Treatment
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* Device: BATwire Implant Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BATwire Kit<br>Subjects will be implanted using the BATwire Implant Kit | Device: BATwire Implant Kit<br>* The BATwire Implant Kit is a delivery system for the placement of the Barostim Carotid Sinus Lead.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |