This trial is active, not recruiting.

Condition uncontrolled hypertension
Treatments neo baroreflex activation therapy system, standard of care medical management only
Sponsor CVRx, Inc.
Start date January 2013
End date September 2017
Trial size 310 participants
Trial identifier NCT01679132, 360039


The Barostim™ Hypertension Pivotal Trial is a prospective, randomized, controlled trial to demonstrate the safety and efficacy of the Barostim Neo system in subjects with resistant hypertension.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Patients are randomized to receive Neo Baroreflex Activation Therapy System device plus optimal medical management.
neo baroreflex activation therapy system Neo System
(Active Comparator)
Patients are randomized to receive optimal medical management alone.
standard of care medical management only
Patients will continue with medical therapy for standard of care of their hypertension.

Primary Outcomes

Primary Safety Objective
time frame: 30 days
Primary Efficacy Objective
time frame: 6 months

Secondary Outcomes

Secondary Efficacy Objective 1
time frame: 12 months
Secondary Efficacy Objective 2
time frame: 12 months
Secondary Safety Objective
time frame: 6 months

Eligibility Criteria

Male or female participants from 21 years up to 80 years old.

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.

Additional Information

Official title CVRx Barostim Hypertension Pivotal Trial
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by CVRx, Inc..