Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-11 @ 12:56 AM
Study NCT ID:
NCT02880618
Status:
UNKNOWN
Last Update Posted:
2023-04-20
First Post:
2016-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-18', 'studyFirstSubmitDate': '2016-08-15', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in New York Heart Association Functional Classification at 6 months Post-Implant', 'timeFrame': 'Baseline, 6 months post-implant', 'description': 'To demonstrate that that treatment with BAROSTIM NEO improves New York Heart Association classification.'}, {'measure': 'Change in Six Minute Hall Walk from Baseline to 6 months Post-Implant', 'timeFrame': 'Baseline, 6 months post-implant', 'description': 'To demonstrate that that treatment with BAROSTIM NEO improves six-minute hall walk performance.'}, {'measure': 'Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant', 'timeFrame': 'Baseline, 6 months post-implant', 'description': 'To demonstrate that that treatment with BAROSTIM NEO reduces left ventricular mass index.'}, {'measure': 'Change in Biomarkers from Baseline to 6 months Post-Implant (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C)', 'timeFrame': 'Baseline, 6 months post-implant', 'description': 'To demonstrate that that treatment with BAROSTIM NEO improves biomarker results.'}, {'measure': 'Number of Hospitalizations over Follow-Up', 'timeFrame': '12 months post-implant', 'description': 'To demonstrate that that treatment with BAROSTIM NEO reduces hospitalizations.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '25982108', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26011593', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25067799', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26132760', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28043438', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.barostimtherapy.com/', 'label': 'BAROSTIM THERAPY'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'Summary:\n\nThe 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.\n\nEligibility:\n\nSubjects 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.\n\nThe contraindications are:\n\n* Bilateral carotid bifurcations located above the level of the mandible\n* Baroreflex failure or autonomic neuropathy\n* Uncontrolled, symptomatic cardiac bradyarrhythmias\n* Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%\n* Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation\n\nObjectives:\n\nTo describe change in the following measures at 3, 6 and 12 months compared to pre-implant baseline:\n\n* New York Heart Association (NYHA) Class\n* Six Minute Hall Walk\n* Echocardiogram measures\n* Biomarkers (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C).\n\nEvaluate health care utilization over follow-up, such as heart failure hospitalizations.\n\nDescribe device programming and utilization'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Subject has been implanted with the BAROSTIM NEO System in the past 30 days\n* Subject has signed an Ethics Committee approved informed consent form\n\nExclusion Criteria:\n\n* Bilateral carotid bifurcations located above the level of the mandible\n* Baroreflex failure or autonomic neuropathy\n* Uncontrolled, symptomatic cardiac bradyarrhythmias\n* Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%\n* Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation'}, 'identificationModule': {'nctId': 'NCT02880618', 'acronym': 'HFrEF', 'briefTitle': 'BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction', 'organization': {'class': 'INDUSTRY', 'fullName': 'CVRx, Inc.'}, 'officialTitle': 'BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System', 'orgStudyIdInfo': {'id': '360049-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Barostim Neo™ System', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '32545', 'city': 'Bad Oeynhausen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Birgit Wellmann', 'role': 'CONTACT', 'email': 'Bwellmann@hdz-nrw.de', 'phone': '+49 5721 973327'}, {'name': 'Klaus-Jürgen Gutleben', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Herzzentrum Bad Oyenhausen', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'zip': '12203', 'city': 'Berlin', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Berlin Charité & Deutschen Herzzentrum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Charité Campus Virchow Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '16321', 'city': 'Bernau', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Immanuel Klinikum Bernau Herzzentrum Brandenburg', 'geoPoint': {'lat': 47.80018, 'lon': 8.0383}}, {'zip': '09113', 'city': 'Chemnitz', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Medizinisches Versorgungszentrum am Küchwald GmbH', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'zip': '50937', 'city': 'Cologne', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Köln Herzzentrum', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '32756', 'city': 'Detmold', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Lippe Klinikum', 'geoPoint': {'lat': 51.93855, 'lon': 8.87318}}, {'zip': '01067', 'city': 'Dresden', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Dresden Friedrichstadt', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '01307', 'city': 'Dresden', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Herzzentrum Dresden - Interventionelle Kardiologie', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '01307', 'city': 'Dresden', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Herzzentrum Dresden, Elektrophysiologie', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '60590', 'city': 'Frankfurt', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Uniklinik Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '35392', 'city': 'Giessen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Gabriele Hellwig', 'role': 'CONTACT', 'email': 'gabriele.hellwig@med.uni-giessen.de', 'phone': '+49 641 985 42632'}, {'name': 'Jörn Schmitt', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Gießen und Marburg', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '37075', 'city': 'Göttingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christine Biegler', 'role': 'CONTACT', 'email': 'cbiegler@med.uni-goettingen.de', 'phone': '+49 551-39-10880'}, {'name': 'Marco Schroeter', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Herzzentrum Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '22457', 'city': 'Hamburg', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Albertinen-Krankenhaus', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22763', 'city': 'Hamburg', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Asklepios Klinik Altona', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '59073', 'city': 'Hamm', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'St. Barbara Klinik Hamm', 'geoPoint': {'lat': 51.68033, 'lon': 7.82089}}, {'zip': '30625', 'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Antje Jürgens', 'role': 'CONTACT', 'email': 'juergens.antje@mh-hannover.de', 'phone': '+49 511 532 6054'}, {'name': 'Christian Veltmann', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '85049', 'city': 'Ingolstadt', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Kardiologie im Klinikum Ingolstadt', 'geoPoint': {'lat': 48.76508, 'lon': 11.42372}}, {'zip': '24105', 'city': 'Kiel', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '77933', 'city': 'Lahr', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Herzentrum Lahr', 'geoPoint': {'lat': 48.34042, 'lon': 7.86886}}, {'zip': '04109', 'city': 'Leipzig', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '04129', 'city': 'Leipzig', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Susanne Reichelt', 'role': 'CONTACT', 'email': 'susanne.reichelt@sanktgeorg.de', 'phone': '+49 341 909-4561'}, {'name': 'Norbert Klein', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Leipzig St. Georg', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '55131', 'city': 'Mainz', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinik Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '48153', 'city': 'Münster', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Clemenshospital Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '33098', 'city': 'Paderborn', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'St. Vincenz-Krankenhaus', 'geoPoint': {'lat': 51.71905, 'lon': 8.75439}}, {'zip': '93053', 'city': 'Regensburg', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Universitätsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '57072', 'city': 'Siegen', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Marienkrankenhaus Siegen', 'geoPoint': {'lat': 50.87481, 'lon': 8.02431}}, {'zip': '48970', 'city': 'Stadtlohn', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Germany', 'facility': 'Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH', 'geoPoint': {'lat': 51.99399, 'lon': 6.91918}}, {'zip': '78532', 'city': 'Tuttlingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ida Weber', 'role': 'CONTACT', 'email': 'i.weber@klinikum-tut.de', 'phone': '+49 7461 97 1415'}, {'name': 'Michael Kotzerke', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum Tuttlingen', 'geoPoint': {'lat': 47.98464, 'lon': 8.8177}}, {'zip': '86100', 'city': 'Campobasso', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Fondazione di Ricerca e Cura "Giovanni Paolo II"', 'geoPoint': {'lat': 41.55947, 'lon': 14.66737}}], 'centralContacts': [{'name': 'Elizabeth Galle', 'role': 'CONTACT', 'email': 'lgalle@cvrx.com', 'phone': '763-416-2876'}], 'overallOfficials': [{'name': 'Jochen Müller-Ehmsen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Asklepios Klinik Altona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CVRx, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}