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Barostim Hypertension Pivotal Trial

Description

High blood pressure can lead to serious medical problems including heart attack, stroke and kidney failure. There is a need for more effective treatments for high blood pressure especially in patients with difficult to control blood pressure. The purpose of this study is to evaluate the investigational device called the Neo system, in patients with resistant high blood pressure. The Neo system includes the following components: an implantable pulse generator and a carotid sinus lead. The lead of the device is placed alongside the baroreceptor in the carotid artery (this is an area that is important in blood pressure control). The carotid lead attaches to an implantable pulse generator placed under the skin of the chest. As blood pressure increases the pulse generator sends pulses to the carotid leads, stimulating the baroreceptors to counteract the rise in blood pressure. This study is a prospective, randomized trial in which the device will be compared with medical therapy. Participants will be randomized in a 1:1 ratio to receive a device plus optimal medical management or to receive optimal medical management alone. Participants will be followed over three years to determine the safety of the device (collect adverse event data) and the efficacy of the device (comparing control of systolic blood pressure to medical management). Statistical analysis will be performed to determine address the objectives safety by comparing adverse events between the two groups and efficacy by comparing blood pressure control.

Phase

N/A

Inclusion and Exclusion Criteria

  • Inclusion Criteria Highlights:
  • Age at least 21 years and no more than 80 years at the time of randomization.
  • On four or more maximally tolerated anti-hypertensive medications, one of which is a diuretic. The antihypertensive medication regimen must remain unchanged for 4 weeks prior to screening and must be expected to remain unchanged for at least 6 months during follow-up.
  • Protocol defined systolic blood pressure greater than or equal to 160 mmHg.
  • Protocol defined 24-hour Ambulatory Blood Pressure Monitoring (ABPM) greater than or equal to 135 mmHg.
  • Serum estimated glomerular filtration rate (eGFR) > 29 mL/min/1.73 m^2.
  • Appropriate surgical candidate.
  • Women of childbearing potential must use a medically accepted method of birth control 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 randomization. Exclusion Criteria Highlights:
  • Known or suspected baroreflex failure or autonomic neuropathy.
  • Myocardial infarction, hypertensive crisis, symptomatic orthostatic hypotension, unstable angina, syncope, or cerebral vascular accident within the 3 months.
  • Hypertension secondary to an identifiable and treatable cause other than sleep apnea.
  • Prior surgery, radiation, or endovascular stent placement in the carotid sinus region.

Sites

  • California

    • University of Southern California, Los Angeles, California, 90033
  • Nevada

    • University Medical Center of Southern Nevada, Las Vegas, Nevada, 89102
  • Arizona

    • Arizona Heart Rhythm Research Center, Phoenix, Arizona, 85006
  • Oklahoma

    • Oklahoma Heart hospital, Oklahoma City, Oklahoma, 73120
  • Louisiana

    • Cardiovascular Institute of the South, Houma, Louisiana, 70361
  • Wisconsin

    • Aspirus Wausau Hospital, Wausau, Wisconsin, 54401
  • Michigan

    • Cardiac and Vascular Research Center of Northern Michigan, Petosky, Michigan, 49770
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