Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT07098858
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The WiSE®-UP Registry (The WiSE System Utilization & Performance Registry)
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2032-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-07-10', 'studyFirstSubmitQcDate': '2025-07-25', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety', 'timeFrame': '1, 6, 12, 24, 48 and 60 months', 'description': 'The primary outcome measure of the Registry is the rate of serious adverse events (SAEs) at \\< 30 days post implant related to the WiSE System and/or implant procedure.'}], 'secondaryOutcomes': [{'measure': 'Efficacy 1', 'timeFrame': '1 month', 'description': 'Procedural Success of the Leadless LV endocardial pacing (LVEP)'}, {'measure': 'Efficacy 2', 'timeFrame': '1 month', 'description': 'CRT response assessment of NYHA functional classification'}, {'measure': 'Efficacy 3', 'timeFrame': '6 months', 'description': 'Left ventricular ejection fraction (LVEF)'}, {'measure': 'Efficacy 4', 'timeFrame': '6 months', 'description': 'Left ventricular and systolic volume (LVESV)'}, {'measure': 'Efficacy 5', 'timeFrame': '1, 6, 12, 24, 48 and 60 months', 'description': 'Heart failure clinical composite score (HF CCS) categorizing patients as improved, unchanged or worsened'}, {'measure': 'Efficacy 6', 'timeFrame': '1, 6, 12, 24, 48 and 60 months', 'description': 'New York Heart Association (NYHA) classification values of Markedly improved, Moderately improved, Mild improvement, No change or Slightly worse'}, {'measure': 'Efficacy 7', 'timeFrame': '1, 6, 12, 24, 48 and 60 months', 'description': 'QRS duration'}, {'measure': 'Efficacy 8', 'timeFrame': '6 and 12 months', 'description': "Minnesota Living with Heart Failure Questionnaire (MLHFQ) a validated tool designed to assess the impact of heart failure on a patient's quality of life"}, {'measure': 'Efficacy 9', 'timeFrame': '1, 6, 12, 24, 48 and 60 months', 'description': 'Events assessment: confirmation of reportable events including updates to any previously reported events'}, {'measure': 'Efficacy 10', 'timeFrame': '1, 6, 12, 24, 48 and 60 months', 'description': 'Mortality is based on an estimated 1-year rate of 10%- and 1-year attrition of up to 15%'}, {'measure': 'Efficacy 11', 'timeFrame': '1, 6, 12, 24, 48 and 60 months', 'description': 'Patient global assessment'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Observe to understand product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System', 'detailedDescription': 'The WiSE-UP Registry is a prospective, real-world, observational study aimed at understanding acute and long-term product performance, including patient safety, clinical outcomes, and CRT response information associated with the use of the market-released WiSE System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Up to 320 patients will be enrolled in the registry and followed for five years.', 'healthyVolunteers': False, 'eligibilityCriteria': '* Patient or legally authorized representative can provide written authorization and/or consent per institution requirements.\n* Patient is intended to receive a WiSE System and passed the acoustic window screening\n* Patient who is, or will be, accessible for follow-up.\n* Participation is not excluded by local law.\n* Patient is not enrolled in a concurrent drug and/or device study that may confound the Registry results.\n* Patient life expectancy \\>1 year.'}, 'identificationModule': {'nctId': 'NCT07098858', 'briefTitle': 'The WiSE®-UP Registry (The WiSE System Utilization & Performance Registry)', 'organization': {'class': 'INDUSTRY', 'fullName': 'EBR Systems, Inc.'}, 'officialTitle': 'The WiSE®-UP Registry (The WiSE System Utilization & Performance Registry)', 'orgStudyIdInfo': {'id': 'CSP-10005'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single-arm, prospective, multicenter, observational study.', 'description': 'Market-released WiSE System approved for commercial release with a market-released co-implanted system are eligible.', 'interventionNames': ['Device: The Wise System']}], 'interventions': [{'name': 'The Wise System', 'type': 'DEVICE', 'description': 'The WiSE CRT System is an implantable cardiac system to provide left ventricular (LV) pacing stimulation in conjunction with a co-implanted system that provides right ventricular (RV) stimulation. In combination, the devices deliver biventricular (BiV) pacing.', 'armGroupLabels': ['Single-arm, prospective, multicenter, observational study.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72404', 'city': 'Jonesboro', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kayla Rubino', 'role': 'CONTACT', 'email': 'krubino@dnairresearch.com'}, {'name': 'Devi Nair', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arrhythmia Research Group (St. Bernards Hospital)', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Linda Pastorious', 'role': 'CONTACT', 'email': 'linda.pastorius@nchmd.org'}, {'name': 'Dinesh Sharma', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Naples Community Hospital', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}], 'centralContacts': [{'name': 'Jamie Burke', 'role': 'CONTACT', 'email': 'clinical@ebrwise.com', 'phone': '17194644185'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EBR Systems, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}