BAROSTIM THERAPY for Resistant Hypertension after Implant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry enrolls up to 500 adults who recently received the BAROSTIM NEO device for resistant hypertension at up to 50 sites. Data are collected from routine clinical measurements before implant, at baseline, and at 3, 6, and 12 months post-implant, with follow-up every six months for up to three years. The study aims to track blood pressure and safety outcomes in the commercial setting after implantation under CE-Mark indications. Participation requires informed consent and adherence to device-specific inclusion and exclusion criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• Immanuel Klinikum Bernau Herzzentrum Brandenburg
  Bernau, Germany Recruiting
• Universitätsklinikum Köln Herzzentrum
  Cologne, Germany Recruiting
• Lippe Klinikum
  Detmold, Germany Recruiting
• Herzzentrum Dresden
  Dresden, Germany Recruiting
• Cardiovascular Center 'CVC' Frankfurt
  Frankfurt, Germany Recruiting
• Universitätsklinikum Gießen und Marburg
  Giessen, Germany Recruiting

Study contacts

• Study coordinator: Nicole Baumann
• Email: nbaumann@cvrx.com
• Phone: 763-416-2331

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.