Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:29 AM
Study NCT ID:
NCT07352657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-06
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices: The RAPTOR-CIED Study (Main Phase)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2031-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiac events', 'timeFrame': '2 years', 'description': 'Incidence of MACE (i.e., death, stroke or systemic embolism, and unplanned cardiac device procedure)'}, {'measure': 'Effectiveness', 'timeFrame': '2 Years', 'description': 'Proportion of total device related encounters that are actionable (e.g., changes in programming or treatment)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pacemaker', 'Implantable Defibrillator']}, 'descriptionModule': {'briefSummary': 'he 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 Main 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': 'NCT07352657', 'acronym': 'RAPTOR - MAIN', 'briefTitle': 'Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices: The RAPTOR-CIED Study (Main Phase)', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Remote Alert Pathway To Optimize CaRe of Cardiac Implantable Electrical Devices: The RAPTOR-CIED Study (Main Phase)', 'orgStudyIdInfo': {'id': '2025P001064'}}, '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': ['Other: Guideline-based Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alert-based care', 'description': 'Alert-based care is an alternative strategy for longitudinal management of patients with wireless pacemakers and implantable defibrillators', 'interventionNames': ['Other: Alert-based care']}], 'interventions': [{'name': 'Alert-based care', 'type': 'OTHER', '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': 'OTHER', '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', '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': 'Daniel B Kramer, MD, MPH', 'role': 'CONTACT', 'email': 'dkramer@bidmc.harvard.edu', 'phone': '617-667-8800'}]}, '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'}}}}