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BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction

Recruitingn/aAges any - anyAllCVRx, Inc.
NCT02880618 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this registry (NCT02880618) 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 heart failure with reduced ejection fraction (HFrEF).

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📋 Eligibility rules (as published)
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
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What it tests

  • Barostim Neo™ System
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Where

30 sites
Albertinen-Krankenhaus
Hamburg, Germany
Herzzentrum Bad Oyenhausen
Bad Oeynhausen, Germany
Berlin Charité & Deutschen Herzzentrum Berlin
Berlin, Germany
Charité Campus Virchow Klinikum
Berlin, Germany
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, Germany
Medizinisches Versorgungszentrum am Küchwald GmbH
Chemnitz, Germany
Universitätsklinikum Köln Herzzentrum
Cologne, Germany
Lippe Klinikum
Detmold, Germany

…and 22 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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