Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-28 @ 12:08 AM
Study NCT ID:
NCT01471860
Status:
UNKNOWN
Last Update Posted:
2019-11-04
First Post:
2011-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BAROSTIM NEO System in the Treatment of Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011216', 'term': 'Practice Management, Medical'}], 'ancestors': [{'id': 'D020399', 'term': 'Practice Management'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-08-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-31', 'studyFirstSubmitDate': '2011-11-09', 'studyFirstSubmitQcDate': '2011-11-10', 'lastUpdatePostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System', 'timeFrame': 'For the duration of the study, up to 5 years.', 'description': 'Ascertain the type, frequency, severity and timing of long-term adverse events in participants implanted with the device, while providing a viable treatment option to participants currently implanted with the BAROSTIM NEO System.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '25982108', 'type': 'RESULT', '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': '29705650', 'type': 'DERIVED', 'citation': 'Halbach M, Abraham WT, Butter C, Ducharme A, Klug D, Little WC, Reuter H, Schafer JE, Senni M, Swarup V, Wachter R, Weaver FA, Wilks SJ, Zile MR, Muller-Ehmsen J. Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. Int J Cardiol. 2018 Sep 1;266:187-192. doi: 10.1016/j.ijcard.2018.04.075. Epub 2018 Apr 21.'}, {'pmid': '26011593', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.', 'detailedDescription': 'The Neo Randomized Heart Failure Study is a prospective, randomized, study describing the safety and efficacy of the BAROSTIM NEO System in the heart failure participants with a left ventricular ejection fraction ≤ 35%.\n\nDuring long-term follow-up, all participants are required to have at least one annual visit.\n\nParameters assessed during long-term follow-up visits:\n\n* Physical Assessment\n* Subject Medications\n* Serious adverse events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Actively participating in the Neo Randomized Heart Failure Study.\n* Have signed a revised approved informed consent form for continued participation in this study.\n\nExclusion Criteria:\n\n* Treating physician decision that the subject should not continue with therapy.'}, 'identificationModule': {'nctId': 'NCT01471860', 'briefTitle': 'BAROSTIM NEO System in the Treatment of Heart Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'CVRx, Inc.'}, 'officialTitle': 'Neo Randomized Heart Failure Study', 'orgStudyIdInfo': {'id': '360029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device and Medical Management', 'description': "Medical Management, to be determined by the participant's physician, described as:\n\n* Optimal pharmacological therapy: Prescribed to a beta blocker, a diuretic, and an ACE (Angiotensin-converting-enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) unless contraindicated or not tolerated. These drugs must be used in a manner consistent with their labeling.\n* Stable pharmacological therapy: No more than a 50% increase or a 50% decrease of the dosage of any one medication, and post titration of all heart failure medications.\n\nParticipants should remain on their prescribed heart failure medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study.", 'interventionNames': ['Device: BAROSTIM NEO System', 'Drug: Medical Management']}], 'interventions': [{'name': 'BAROSTIM NEO System', 'type': 'DEVICE', 'otherNames': ['XR-1 System', 'Neo System'], 'armGroupLabels': ['Device and Medical Management']}, {'name': 'Medical Management', 'type': 'DRUG', 'armGroupLabels': ['Device and Medical Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta - Edmonton', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R2H 2A6', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'St. Boniface Hospital', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '590347', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '31073', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '10967', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Vivantes Hospital Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '16321', 'city': 'Bernau', 'country': 'Germany', 'facility': 'Immanuel Hospital Bernau-Heart Center Brandenburg', 'geoPoint': {'lat': 47.80018, 'lon': 8.0383}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'University Hospital Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'University Hospital Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60389', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'CVC Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'University Hospital Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Georg August University - Goettingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Klinik St. Georg, Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Heart Center Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'University Hospital of Schleswig-Holstein, Kiel Campus', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '04129', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Klinikum St. Georg Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '58515', 'city': 'Lüdenscheid', 'country': 'Germany', 'facility': 'Klinikum Ludenscheid', 'geoPoint': {'lat': 51.21977, 'lon': 7.6273}}, {'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'University Hospital Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '41464', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Lukas Hospital Neuss', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}, {'zip': '26133', 'city': 'Oldenburg', 'country': 'Germany', 'facility': 'Oldenburg Hospital', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'zip': '21465', 'city': 'Reinbek', 'country': 'Germany', 'facility': 'Reinbek Hospital, St. Adolf-Stift', 'geoPoint': {'lat': 53.51703, 'lon': 10.2488}}, {'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '60126', 'city': 'Ancona', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Opedali', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '24128', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Spedali Riuniti Di Bergamo', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Azienda Ospedaliero - Universitaria Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20149', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Scientifico San Luca', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Uta Hoppe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cologne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CVRx, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}