Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-21 @ 10:32 PM
Study NCT ID:
NCT03561805
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-20
First Post:
2018-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015716', 'term': 'Electrocardiography, Ambulatory'}], 'ancestors': [{'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D018670', 'term': 'Monitoring, Ambulatory'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2018-04-13', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arrhythmic events', 'timeFrame': 'Within 3 months prior to the TAVI procedure', 'description': 'Incidence and type of arrhythmic events'}, {'measure': 'Therapeutic changes', 'timeFrame': 'Within 3 months prior to the TAVI procedure', 'description': 'incidence of arrhythmic events identified by the device leading to therapeutic changes prior to the TAVI procedure'}], 'secondaryOutcomes': [{'measure': 'Atrial fibrillation', 'timeFrame': 'Within 3 months prior to the TAVI procedure', 'description': 'incidence of atrial fibrillation'}, {'measure': 'Atrial fibrillation', 'timeFrame': 'Within 3 months prior to the TAVI procedure', 'description': 'duration of atrial fibrillation'}, {'measure': 'Atrioventricular block', 'timeFrame': 'Within 3 months prior to the TAVI procedure', 'description': 'incidence of advanced atrioventricular block'}, {'measure': 'Severe bradycardia', 'timeFrame': 'Within 3 months prior to the TAVI procedure', 'description': 'incidence of severe bradycardia'}, {'measure': 'Left bundle branch block', 'timeFrame': 'Within 3 months prior to the TAVI procedure', 'description': 'incidence of left bundle branch block'}, {'measure': 'Permanent pacemaker', 'timeFrame': 'Within 3 months prior to the TAVI procedure', 'description': 'percentage of patients with an indication of permanent pacemaker'}, {'measure': 'Anticoagulation therapy', 'timeFrame': 'Within 3 months prior to the TAVI procedure', 'description': 'percentage of patients with an indication for anticoagulation therapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TAVI', 'ECG monitoring'], 'conditions': ['Aortic Valve Stenosis', 'Arrythmia']}, 'descriptionModule': {'briefSummary': 'Patients with severe aortic stenosis candidates for a TAVI procedure harbor a high burden of silent arrhythmic events. Pre-procedural detection of such arrhythmias should help the investigators to implement specific therapeutic measures that may improve patient outcomes and reduce hospitalization length post-TAVI.', 'detailedDescription': 'This is a prospective registry including patients accepted by the heart team for a TAVI procedure. Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure. The duration of the ECG monitoring will be of 1 week. There will be no restriction regarding the type of valve and approach used for the TAVI procedure. All type of arrhythmic events will be recorded, as well as the specific therapeutic measures implemented upon the occurrence of the arrhythmic event. Following the TAVI procedure, the patients will be monitored (telemetry) until hospital discharge. All arrhythmic events during the hospitalization period will be recorded. Clinical follow-up will be performed at 30 days, and 1 year post-TAVI, and yearly thereafter up to 5-year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with severe aortic stenosis accepted for a TAVI procedure by the Heart Team.\n\nExclusion Criteria:\n\n* Urgent TAVI procedure or logistic reasons precluding an ECG monitoring of at least 1 week within the 3 months prior to the TAVI procedure.\n* Prior permanent pacemaker.'}, 'identificationModule': {'nctId': 'NCT03561805', 'briefTitle': 'Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval'}, 'officialTitle': 'Prolonged Continuous ECG Monitoring Prior to TrAnscatheter AoRtic ValvE Implantation: the PARE Study', 'orgStudyIdInfo': {'id': 'PARE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Prolonged continuous ECG monitoring', 'description': 'Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure. The duration of the ECG monitoring will be of 1 week.', 'interventionNames': ['Device: ECG monitoring']}], 'interventions': [{'name': 'ECG monitoring', 'type': 'DEVICE', 'description': 'Prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure', 'armGroupLabels': ['Prolonged continuous ECG monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'IUCPQ', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Josep Rodes-Cabau', 'investigatorAffiliation': "Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec"}}}}