BAROSTIM THERAPY™ In Resistant Hypertension
ConditionHypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCVRx, Inc.
About this trial
The purpose of this registry (NCT02880631) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO System in the commercial setting in subjects recently implanted under the CE-Marked indication for resistant hypertension.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has signed an EC approved informed consent form
Has been implanted with the BAROSTIM NEO system in the past 30 days
Systolic blood pressure greater than or equal to 140 mmHg, and
Resistance to maximally tolerated therapy with a diuretic and two other anti-hypertension medications
Disqualifiers
Bilateral carotid bifurcations located above the level of the mandible
Baroreflex failure or autonomic neuropathy
Uncontrolled, symptomatic cardiac bradyarrhythmias
Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
Trial population
Subjects can be included in the Hypertension Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications and contraindications for the BAROSTIM NEO System in the treatment of resistant hypertension.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
BAROSTIM NEO™ System
Device
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Blood Pressure Changes
The results of an office cuff blood pressure measurement to be obtained from a time point prior to implant and as close to the implant procedure as possible (baseline), at 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.
Time frame
Pre-implant baseline to 3 years post-implant2
Cardiovascular Medication Changes
Information on currently-utilized doses of cardiovascular medications will be collected at pre-implant baseline, 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.
Time frame
Post-implant enrollment to 3 years post-implant3
Number of Health Care Utilizations
Health care utilization information (e.g. heart failure hospitalizations) is collected at 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.
Time frame
3 months post-implant to 3 years post-implant Source ClinicalTrials.gov