BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction
NCT ID: NCT02880618
Last Updated: 2023-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2016-12-13
2024-07-31
Brief Summary
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Detailed Description
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The CVRx BAROSTIM THERAPY in Heart Failure with Reduced Ejection Fraction (HFrEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for heart failure. Subjects must be enrolled within 30 days from implant. Up to 500 subjects will be enrolled at up to 50 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3, 6, and 12 months after the device was implanted, at which time each subject will be exited from the registry.
Eligibility:
Subjects can be included in the Heart Failure with Reduced Ejection Fraction Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications, and are not contraindicated, for the BAROSTIM NEO System in the treatment of heart failure. The BAROSTIM NEO System is indicated for subjects with 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.
The contraindications are:
* 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
Objectives:
To describe change in the following measures at 3, 6 and 12 months compared to pre-implant baseline:
* New York Heart Association (NYHA) Class
* Six Minute Hall Walk
* Echocardiogram measures
* Biomarkers (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C).
Evaluate health care utilization over follow-up, such as heart failure hospitalizations.
Describe device programming and utilization
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Barostim Neo™ System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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CVRx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jochen Müller-Ehmsen, PhD
Role: STUDY_CHAIR
Asklepios Klinik Altona
Locations
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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
Dresden Friedrichstadt
Dresden, , Germany
Herzzentrum Dresden - Interventionelle Kardiologie
Dresden, , Germany
Herzzentrum Dresden, Elektrophysiologie
Dresden, , Germany
Uniklinik Frankfurt
Frankfurt, , Germany
Universitätsklinikum Gießen und Marburg
Giessen, , Germany
Herzzentrum Göttingen
Göttingen, , Germany
Albertinen-Krankenhaus
Hamburg, , Germany
Asklepios Klinik Altona
Hamburg, , Germany
St. Barbara Klinik Hamm
Hamm, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Kardiologie im Klinikum Ingolstadt
Ingolstadt, , Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, , Germany
Herzentrum Lahr
Lahr, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Leipzig St. Georg
Leipzig, , Germany
Universitätsklinik Mainz
Mainz, , Germany
Clemenshospital Münster
Münster, , Germany
St. Vincenz-Krankenhaus
Paderborn, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
Marienkrankenhaus Siegen
Siegen, , Germany
Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH
Stadtlohn, , Germany
Klinikum Tuttlingen
Tuttlingen, , Germany
Fondazione di Ricerca e Cura "Giovanni Paolo II"
Campobasso, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.
Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10.
Gronda E, Seravalle G, Brambilla G, Costantino G, Casini A, Alsheraei A, Lovett EG, Mancia G, Grassi G. Chronic baroreflex activation effects on sympathetic nerve traffic, baroreflex function, and cardiac haemodynamics in heart failure: a proof-of-concept study. Eur J Heart Fail. 2014 Sep;16(9):977-83. doi: 10.1002/ejhf.138. Epub 2014 Jul 28.
Gronda E, Seravalle G, Trevano FQ, Costantino G, Casini A, Alsheraei A, Lovett EG, Vanoli E, Mancia G, Grassi G. Long-term chronic baroreflex activation: persistent efficacy in patients with heart failure and reduced ejection fraction. J Hypertens. 2015 Aug;33(8):1704-8. doi: 10.1097/HJH.0000000000000603.
Weaver FA, Abraham WT, Little WC, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Madershahian N, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Zile MR. Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction. Semin Thorac Cardiovasc Surg. 2016 Summer;28(2):320-328. doi: 10.1053/j.semtcvs.2016.04.017. Epub 2016 Jun 2.
Related Links
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BAROSTIM THERAPY
Other Identifiers
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360049-001
Identifier Type: -
Identifier Source: org_study_id
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