Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-29 @ 5:49 AM
Study NCT ID:
NCT06937658
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-22
First Post:
2025-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-04-18', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enrollment', 'timeFrame': '6 months', 'description': 'Number of patients enrolled and randomized per site and per month, and cumulatively'}, {'measure': 'Adherence', 'timeFrame': '6 months', 'description': 'Proportion of cross-over'}], 'secondaryOutcomes': [{'measure': 'Major adverse cardiac events', 'timeFrame': '6 months', 'description': 'Incidence of MACE (i.e., death, stroke or systemic embolism, and unplanned cardiac device procedure)'}, {'measure': 'Major adverse cardiac events', 'timeFrame': '6 months', 'description': 'Incidence of arrhythmia events, individual components of MACE, and health services use (i.e., hospital presentations)'}, {'measure': 'Effectiveness', 'timeFrame': '6 months', 'description': 'Total number and type of device related encounters'}, {'measure': 'Effectiveness', 'timeFrame': '6 months', 'description': 'Proportion of total device related encounters that are actionable (e.g., changes in programming or treatment)'}, {'measure': 'Connectivity', 'timeFrame': '6 months', 'description': '• Proportion of 24-, 48-, and 72-hour periods with versus without connected wireless monitoring'}, {'measure': 'Quality of Life and Health Status', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'EuroQol 5-dimensional questionnaire, five-level version (EQ-5D-5L) - 5 questions are scored from 1 to 5, with higher scores indicating worse outcomes'}, {'measure': 'Quality of Life and Health Status', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'Cardiac Anxiety Questionnaire (CAQ) - scored from 0 to 72, with a higher score corresponding to higher cardiac anxiety'}, {'measure': 'Quality of Life and Health Status', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'Patient Health Questionnaire depression scale (PHQ-8) - scored from 0 to 24, with a higher score indicating worse symptoms'}, {'measure': 'Quality of Life and Health Status', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'Patient Activation Measure (PAM) - scored from 0 to 100, with a higher score indicating better outcomes'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pacemaker DDD', 'Implantable Defibrillator User']}, 'descriptionModule': {'briefSummary': 'The Remote Alert Pathway to Optimize Care of Cardiac Implantable Electrical Devices (RAPTOR-CIED) Study is a pragmatic, multi-center, randomized trial with 1:1 patient-level randomization comparing the safety and effectiveness of alert-driven care versus guideline-based care for patients with wireless cardiac implantable electrical devices (CIEDs).\n\nThe study will be conducted in 2 phases: a Feasibility Phase and a Main Phase. This registration outlines the goals and design features of the Feasibility Phase of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult aged \\> 18 years\n2. Clinically stable by investigator assessment\n3. Has a newly implanted or existing wireless CIED: single, dual-chamber, biventricular, subcutaneous/extravascular, and leadless systems are all eligible, including pacemakers or implantable cardioverter-defibrillators (ICDs)\n4. CIED is from one of the 4 major CIED manufacturers in the US market (99% of implants in the US): Medtronic, Boston Scientific, Abbott, Biotronik\n5. Currently enrolled in remote monitoring as part of standard of care\n6. Primary clinical electrophysiology follow-up at the enrolling center\n7. Understands spoken and written English, Spanish, or Portuguese\n8. Has sufficient cognitive function to answer standardized questions about study rationale and procedures.\n\nExclusion Criteria:\n\n1. Presence of insertable cardiac monitor, either in isolation or in combination with any other CIED\n2. Listed for cardiac transplantation prior to enrollment (N.B. if a patient becomes listed for transplantation during the study, they may continue study participation)\n3. Participation in another study related to novel CIED technology or remote monitoring.'}, 'identificationModule': {'nctId': 'NCT06937658', 'acronym': 'RAPTOR-CIED', 'briefTitle': 'Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices', 'orgStudyIdInfo': {'id': 'PLACER-2023C3-34968'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Guideline-based Care', 'description': 'Remote monitoring programming scheduled for alert transmissions, patient-initiated transmissions, and routine transmissions (scheduled to occur every 90 days from the date of enrollment in the study); in-office interrogations on at least an annual basis', 'interventionNames': ['Device: Guideline-based care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alert-based Care', 'description': 'Remote monitoring programming scheduled for alert transmissions and patient-initiated transmissions only', 'interventionNames': ['Device: Alert-based care']}], 'interventions': [{'name': 'Alert-based care', 'type': 'DEVICE', 'description': 'Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators', 'armGroupLabels': ['Alert-based Care']}, {'name': 'Guideline-based care', 'type': 'DEVICE', 'description': 'Guideline-based care is the current typical standard for longitudinal management of patients with wireless pacemakers and implantable defibrillators', 'armGroupLabels': ['Guideline-based Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Linda Valsdottir, MS', 'role': 'CONTACT', 'email': 'lvalsdot@bidmc.harvard.edu', 'phone': '6176678800'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Daniel B. Kramer', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}