First-In-Human Study Evaluating a Novel Catheter Device in Subjects With Treatment-Resistant Hypertension

First-In-Human Study for Ultrasound Based Endovascular Carotid Body Ablation in Subjects With Treatment-Resistant Hypertension: A Safety and Feasibility Study

The carotid body is located at the bifurcation of the internal and external carotid arteries. It is a chemoreceptor that plays a role in the sympathetic nervous system and in the development and maintenance of hypertension. Hypertension is a major cardiovascular risk factor and is associated with coronary artery disease, stroke, chronic kidney disease, and heart failure.

The objective of this study is to assess the effectiveness and safety of a catheter-based system to ablate the carotid body and reduce blood pressure (BP) in patients with resistant hypertension and to confirm sustainability of the treatment benefits long-term as seen following surgical CB removal.

Inclusion Criteria:

• Mean office SBP ≥160 mmHg and DBP ≥90 mmHg during screen-in period
• Mean daytime systolic ABPM ≥135 mmHg during screen-in period
• Adherent to a stable drug regimen of three (3) or more anti-hypertensive medications of different classes (including one (1) diuretic), with no medication changes expected for at least six (6) months post-procedure
• No change in anti-hypertensive drug prescription (dose, number of medications, or class of medication) for at least six (6) weeks prior to enrollment
• Negative pregnancy test for women of child-bearing age
• Willingness and able to comply with follow-up requirements
• Signed informed consent

Exclusion Criteria:

• Secondary causes of hypertension
• Calculated eGFR <30mL/min/1.73m2
• History of repeated episodes of hypoglycemic unawareness
• Morbid obesity, defined as Body Mass Index >40 kg/m2
• Severe obstructive sleep apnea (AHI > 35/hr.)
• Pacemaker and/or implantable defibrillators
• History of transient ischemic accident or cerebrovascular accident during six (6) months prior to screening
• History of acute heart failure, congestive heart failure (NYHA class III-IV), myocardial infarction, unstable angina, coronary bypass or coronary angioplasty during six (6) months prior to screening
• History of ipsilateral carotid endarterectomy treatment or ipsilateral carotid artery stenting