NCT02880631 BAROSTIM THERAPY™ In Resistant Hypertension
| NCT ID | NCT02880631 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CVRx, Inc. |
| Condition | Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2016-12-13 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2016-12-13 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Exclusion Criteria: * 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% * Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
Contact & Investigator
Hannes Reuter, PhD
STUDY CHAIR
Herzzentrum Uniklinik Köln
Frequently Asked Questions
Who can join the NCT02880631 clinical trial?
This trial is open to participants of all sexes, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02880631 currently recruiting?
Yes, NCT02880631 is actively recruiting participants. Contact the research team at nbaumann@cvrx.com for enrollment information.
Where is the NCT02880631 trial being conducted?
This trial is being conducted at Berlin, Germany, Berlin, Germany, Bernau, Germany, Cloppenburg, Germany and 11 additional locations.
Who is sponsoring the NCT02880631 clinical trial?
NCT02880631 is sponsored by CVRx, Inc.. The principal investigator is Hannes Reuter, PhD at Herzzentrum Uniklinik Köln. The trial plans to enroll 500 participants.