BAROSTIM THERAPY in heart failure with reduced ejection fraction

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 with heart failure and LVEF ≤ 35% who were implanted with the BAROSTIM NEO System within the last 30 days, across up to 50 sites. Data are collected from standard-of-care measurements before implantation, at enrollment, and at 3, 6, and 12 months post-implant to understand outcomes after device therapy. Enrollment is limited to CE-mark indicated patients without specified contraindications, with follow-up through 12 months. The study aims to describe real-world safety and effectiveness signals of BAROSTIM therapy in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject has heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy
* Subject has been implanted with the BAROSTIM NEO System in the past 30 days
* Subject has signed an Ethics Committee approved informed consent form

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

• Herzzentrum Bad Oyenhausen
  Bad Oeynhausen, Germany Recruiting
• Universitätsklinikum Gießen und Marburg
  Giessen, Germany Recruiting
• Medizinische Hochschule Hannover
  Hanover, Germany Recruiting
• Leipzig St. Georg
  Leipzig, Germany Recruiting
• Klinikum Tuttlingen
  Tuttlingen, Germany Recruiting
• Albertinen-Krankenhaus
  Hamburg, Free and Hanseatic City of Hamburg, Germany Active not recruiting

Study contacts

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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.