Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2025-12-28 @ 1:28 AM
Study NCT ID:
NCT05744934
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080039', 'term': 'Univentricular Heart'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2027-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with successful ILR implantation at the time of surgery', 'timeFrame': 'At the time of stage 1 surgery, typically the first week of life', 'description': 'Feasibility of ILR implantation'}, {'measure': 'Number of patients with ILR related complication (any of: infection, erosion, device migration, foreign body rejection phenomena, formation of hematomas or seromas, local tissue reaction and/or tissue damage', 'timeFrame': 'Between the stage 1 and stage 2 surgery, typically until 4-6 months of age', 'description': 'Safety of ILR implantation'}], 'secondaryOutcomes': [{'measure': 'Number of patient who completed >70% planned ILR transmissions', 'timeFrame': 'Between the stage 1 and stage 2 surgery, typically until 4-6 months of age'}, {'measure': 'Number of patients with arrhythmias', 'timeFrame': 'Between the stage 1 and stage 2 surgery, typically until 4-6 months of age', 'description': 'Any arrhythmia, including supraventricular tachycardia, junctional ectopic tachycardia, ventricular tachycardia, atrioventricular block, pause \\>2.5 seconds'}, {'measure': 'Number of patients with interstage complication', 'timeFrame': 'Between the stage 1 and stage 2 surgery, typically until 4-6 months of age', 'description': 'Any complication, including unplanned emergency department visit, unscheduled hospital admission, unscheduled intensive care unit admission, arrhythmias, major interstage intervention, minor interstage intervention, cardiac arrest, death'}, {'measure': 'Complications at the time of ILR removal', 'timeFrame': 'At stage 2 or 3 palliation, typically between 4 months and 4 years of age', 'description': 'Defined as easily removed, removed with difficulty, removed with complication'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Univentricular Heart']}, 'descriptionModule': {'briefSummary': 'The primary objective of this investigation is to evaluate the feasibility and safety of implantable loop recorder implantation (using the LUX-DX™) in newborns undergoing stage 1 palliation. The secondary objective of the investigation is to evaluate the feasibility of continuous measurement of heart rate and arrhythmia using an implantable loop recorder (LUX-Dx™) during the interstage period.\n\nAn implantable loop recorder will be placed at the time of chest closure following stage 1 palliation (either at the time of index surgery or delayed). The device will be placed in a subclavicular pouch through the existing sternotomy incision. Participants will be in the study for 6 months to 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with single ventricle physiology undergoing stage 1 palliation in the 1st month of life\n\nExclusion Criteria:\n\n* Prematurity (\\<36 weeks gestational age)\n* Birth weight \\<2.5 kg\n* Hybrid stage 1 palliation (patent ductus arteriosus stenting, bilateral pulmonary artery bands)\n* Presence and/or need for devices sensitive to magnetic fields such as hearing aids, pacemaker, and other implanted devices.\n* Clinical team does not think that the patient is a good candidate'}, 'identificationModule': {'nctId': 'NCT05744934', 'briefTitle': 'Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study', 'orgStudyIdInfo': {'id': 'IRB-P00044387'}}, 'armsInterventionsModule': {'interventions': [{'name': 'LUX-Dx™', 'type': 'DEVICE', 'description': 'Placement of LUX-Dx at the time of stage 1 palliation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Audrey Dionne, MD', 'role': 'CONTACT'}], 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Audrey Dionne, MD', 'role': 'CONTACT', 'email': 'audrey.dionne@cardio.chboston.org', 'phone': '617-355-0000'}, {'name': 'Olivia Rossi', 'role': 'CONTACT', 'email': 'olivia.rossi@cardio.chboston.org'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Audrey Dionne', 'investigatorAffiliation': "Boston Children's Hospital"}}}}