Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT01679132
Status:
SUSPENDED
Last Update Posted:
2025-07-15
First Post:
2012-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BAROSTIM NEO Hypertension Pivotal Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Company resources only allows adequate oversight for one pivotal trial at a time', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2013-04-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2012-08-31', 'studyFirstSubmitQcDate': '2012-08-31', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.', 'timeFrame': 'For the duration of the study, up to ten years.', 'description': 'Ascertain the type, frequency, severity and timing of long-term adverse events in G120137 study subjects implanted with the device, while providing a viable treatment option to patients currently implanted with the CVRx BAROSTIM NEO System.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Uncontrolled Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).', 'detailedDescription': 'The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension.\n\nAll subjects are now in long term follow-up and are required to have at least one annual visit.\n\nParameters assessed during visits are:\n\n* Office Cuff Blood Pressure\n* Physical Assessment\n* Subject Medications\n* Serious adverse events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Actively participating in the Barostim Hypertension Pivotal Trial and currently implanted with the BAROSTIM NEO device with the device turned ON.\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': 'NCT01679132', 'briefTitle': 'BAROSTIM NEO Hypertension Pivotal Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'CVRx, Inc.'}, 'officialTitle': 'BAROSTIM NEO Hypertension Pivotal Trial', 'orgStudyIdInfo': {'id': '360039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAROSTIM NEO System', 'description': 'Subjects implanted with the BAROSTIM NEO System.', 'interventionNames': ['Device: BAROSTIM NEO System and Medical Management']}], 'interventions': [{'name': 'BAROSTIM NEO System and Medical Management', 'type': 'DEVICE', 'otherNames': ['Neo System'], 'description': "Experimental: Device and Medical Management\n\nSubjects have been implanted with the BAROSTIM NEO System and receive optimal medical management, including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics; Thiazide Diuretics; Potassium-sparing Diuretics; Aldosterone receptor blockers; Beta-blockers; Beta-blockers with intrinsic sympathomimetic activity; Combined alpha- and beta-blockers; ACE inhibitors; Angiotensin II antagonists; Calcium channel blockers- non-Dihydropyridines; Calcium channel blockers- Dihydropyridines; Alpha1-blockers; Central alpha2-agonists and other centrally acting drugs; Direct vasodilators.", 'armGroupLabels': ['BAROSTIM NEO System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Heart Rhythm Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '70360', 'city': 'Houma', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cardiovascular Institute of the South', 'geoPoint': {'lat': 29.59577, 'lon': -90.71953}}, {'zip': '49770', 'city': 'Petoskey', 'state': 'Michigan', 'country': 'United States', 'facility': 'Cardiac and Vascular Research Center of Northern Michigan', 'geoPoint': {'lat': 45.37334, 'lon': -84.95533}}, {'zip': '48601', 'city': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan CardioVascular Institute', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'University Medical Center of Southern Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '54401', 'city': 'Wausau', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Aspirus Wausau Hospital', 'geoPoint': {'lat': 44.95914, 'lon': -89.63012}}], 'overallOfficials': [{'name': 'George Bakris, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The University of Chicago Medicine'}, {'name': 'John Bisognano, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Rochester'}, {'name': 'Fred Weaver, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Keck School of Medicine of the University of Southern California'}, {'name': 'William Abraham, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CVRx, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}