Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 4:28 AM
Study NCT ID:
NCT00710294
Status:
COMPLETED
Last Update Posted:
2011-10-31
First Post:
2008-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Device Based Therapy in Hypertension Extension Trial
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-28', 'studyFirstSubmitDate': '2008-07-02', 'studyFirstSubmitQcDate': '2008-07-03', 'lastUpdatePostDateStruct': {'date': '2011-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describe the safety of Rheos Baroreflex Hypertension Therapy System by evaluating all adverse events and estimating the system and procedure related adverse event rate until and including the 13-month follow-up.', 'timeFrame': 'after last 13-month follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Refractory Hypertension', 'High Blood Pressure', 'Uncontrolled Blood Pressure'], 'conditions': ['Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cvrx.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This clinical investigation is designed to describe the long-term safety and efficacy of the CVRx Rheos Baroreflex Hypertension Therapy System in patients who participated in the DEBuT-HT study beyond the original follow up period (4-months or longer). The information obtained in this trial is intended to support regulatory approvals and market release of this therapy.', 'detailedDescription': 'This extension study, designed as a long-term follow up, will monitor the course of the disease and its treatment safety and efficacy by collecting the appropriate data and using data collected under the long term provisions of the DEBuT-HT study to describe and analyze the changes in ongoing drug treatment, the programming parameters of the implanted active device and any occurring adverse events over a period of up to 13 months after implant surgery in the DEBuT-HT trial. Annual follow-ups of up to five years are planned subsequently to the 13-month follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have completed the follow-up period (4-month or longer) of the DEBuT-HT trial (protocol No.: 360004-001)\n* Have signed an approved informed consent form for participation in this study\n\nExclusion Criteria:\n\n* Are unable to comply with protocol requirements.\n* Are enrolled in another concurrent clinical trial.'}, 'identificationModule': {'nctId': 'NCT00710294', 'acronym': 'DEBuT-HET', 'briefTitle': 'Device Based Therapy in Hypertension Extension Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'CVRx, Inc.'}, 'officialTitle': 'DEBuT - HET: Device Based Therapy in Hypertension Extension Trial: Long-Term Follow-Up Trial for Patients Who Completed the DEBuT-HT Study', 'orgStudyIdInfo': {'id': '360007-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CVRx Rheos Baroreflex Hypertension Therapy System', 'type': 'DEVICE', 'otherNames': ['Rheos Hypertension Therapy', 'Baroreflex Activation Therapy™ (BAT™)', 'Baroreflex Hypertension Therapy'], 'description': 'The pulse generator, which is similar to a pacemaker, is typically implanted under the skin below the collarbone.\n\nTwo small leads from the device are wrapped around the carotid arteries on both sides of the neck and connected to the pulse generator.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bad Oeynhausen', 'country': 'Germany', 'facility': 'University Hospital Bad Oeynhausen', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Campus Buch', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'University Hospital Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Myriah Elletson', 'role': 'STUDY_CHAIR', 'affiliation': 'CVRx, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CVRx, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}