BATwire Implant Kit
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.
- 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.