NCT02880618 BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction
| NCT ID | NCT02880618 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CVRx, Inc. |
| Condition | Heart Failure |
| 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 (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).
Eligibility Criteria
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
Contact & Investigator
Jochen Müller-Ehmsen, PhD
STUDY CHAIR
Asklepios Klinik Altona
Frequently Asked Questions
Who can join the NCT02880618 clinical trial?
This trial is open to participants of all sexes, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02880618 currently recruiting?
Yes, NCT02880618 is actively recruiting participants. Contact the research team at nbaumann@cvrx.com for enrollment information.
Where is the NCT02880618 trial being conducted?
This trial is being conducted at Hamburg, Germany, Bad Oeynhausen, Germany, Berlin, Germany, Berlin, Germany and 11 additional locations.
Who is sponsoring the NCT02880618 clinical trial?
NCT02880618 is sponsored by CVRx, Inc.. The principal investigator is Jochen Müller-Ehmsen, PhD at Asklepios Klinik Altona. The trial plans to enroll 500 participants.
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