Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-23 @ 4:10 AM
Study NCT ID:
NCT01471834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-15
First Post:
2011-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Verification of the Efficacy and Safety of the BAROSTIM NEO System in the Treatment of Drug Resistant Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular 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': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2011-11-09', 'studyFirstSubmitQcDate': '2011-11-10', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To access long-term adverse events in participants implanted with the BAROSTIM NEO System.', 'timeFrame': 'For the duration of the study, up to 10 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 CVRx's BAROSTIM NEO System."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['High Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '28065708', 'type': 'DERIVED', 'citation': 'Wachter R, Halbach M, Bakris GL, Bisognano JD, Haller H, Beige J, Kroon AA, Nadim MK, Lovett EG, Schafer JE, de Leeuw PW. An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems. J Am Soc Hypertens. 2017 Feb;11(2):81-91. doi: 10.1016/j.jash.2016.12.003. Epub 2016 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'To assess the long-term safety and efficacy of the BAROSTIM NEO System in trial (NCT01471834) participants.', 'detailedDescription': 'The Neo Non-Randomized Hypertension Study is a non-randomized, open-label, verification study in participants diagnosed with drug resistant hypertension, defined as medical treatment failure for hypertension defined as office cuff systolic blood pressure (SBP) ≥ 140 mmHg despite being prescribed to at least three antihypertensive medications, including a diuretic, in accordance with the AHA guidelines.\n\nParticipants should remain on their prescribed anti-hypertensive 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.\n\nAll (Canadian) participants are now in long term follow-up and are required to have at least one annual visit.\n\nParameters assessed during long-term follow-up visits:\n\n* Physical Assessment\n* Office Cuff Blood Pressure\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 Neo Non-Randomized Hypertension 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': 'NCT01471834', 'briefTitle': 'Verification of the Efficacy and Safety of the BAROSTIM NEO System in the Treatment of Drug Resistant Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'CVRx, Inc.'}, 'officialTitle': 'Neo Non-Randomized Hypertension Study', 'orgStudyIdInfo': {'id': '360016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device and Medical Management', 'description': "Participants will be implanted with the BAROSTIM NEO System and will continue to receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \\[AHA\\] / American College of Cardiology \\[ACC\\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.", '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 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T2P 1C4', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta - Edmonton', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'N6G 2V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London-Lawson Health Research Institute', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': '50924', 'city': 'Cologn', 'country': 'Germany', 'facility': 'University Hospital Cologne'}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'University Hospital Duesseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Goettingen-Georg August University', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Midizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '04129', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Klinkum St. George Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': 'HX6229', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Hermann Haller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CVRx, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}