Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-02 @ 12:38 AM
Study NCT ID:
NCT04298593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-20
First Post:
2020-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective registry'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2020-01-12', 'studyFirstSubmitQcDate': '2020-03-05', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of arrhythmic events', 'timeFrame': 'within the first weeks after the procedure, an average of 4 weeks', 'description': 'Incidence of arrhythmic events after discharge in TAVI recipients.'}, {'measure': 'Type of arrhythmic events', 'timeFrame': 'within the first weeks after the procedure, an average of 4 weeks', 'description': 'Type of arrhythmic events after discharge in TAVI recipients.'}, {'measure': 'Incidence of arrhythmic events and treatment modification', 'timeFrame': 'within the first weeks after the procedure, an average of 4 weeks', 'description': 'Incidence of arrhythmic events leading to a specific change in treatment.'}, {'measure': 'Type of arrhythmic events and treatment modification', 'timeFrame': 'within the first weeks after the procedure, an average of 4 weeks', 'description': 'Type of arrhythmic events leading to a specific change in treatment.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with pacemaker', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Incidence of permanent pacemaker implantation after the procedure.'}, {'measure': 'Number of participants with treatment modification', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Number of participants who required change in their medication (anticoagulation, antiarrhythmic) after the procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['TAVI', 'ECG Monitoring']}, 'referencesModule': {'references': [{'pmid': '29425605', 'type': 'BACKGROUND', 'citation': 'Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Munoz DR, Rosenhek R, Sjogren J, Mas PT, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL. 2017 ESC/EACTS Guidelines for the Management of Valvular Heart Disease. Rev Esp Cardiol (Engl Ed). 2018 Feb;71(2):110. doi: 10.1016/j.rec.2017.12.013. No abstract available. English, Spanish.'}, {'pmid': '28893961', 'type': 'BACKGROUND', 'citation': 'Auffret V, Puri R, Urena M, Chamandi C, Rodriguez-Gabella T, Philippon F, Rodes-Cabau J. Conduction Disturbances After Transcatheter Aortic Valve Replacement: Current Status and Future Perspectives. Circulation. 2017 Sep 12;136(11):1049-1069. doi: 10.1161/CIRCULATIONAHA.117.028352.'}, {'pmid': '27832847', 'type': 'BACKGROUND', 'citation': "Urena M, Rodes-Cabau J. Conduction Abnormalities: The True Achilles' Heel of Transcatheter Aortic Valve Replacement? JACC Cardiovasc Interv. 2016 Nov 14;9(21):2217-2219. doi: 10.1016/j.jcin.2016.09.040. No abstract available."}, {'pmid': '19652115', 'type': 'BACKGROUND', 'citation': 'Moreno R, Dobarro D, Lopez de Sa E, Prieto M, Morales C, Calvo Orbe L, Moreno-Gomez I, Filgueiras D, Sanchez-Recalde A, Galeote G, Jimenez-Valero S, Lopez-Sendon JL. Cause of complete atrioventricular block after percutaneous aortic valve implantation: insights from a necropsy study. Circulation. 2009 Aug 4;120(5):e29-30. doi: 10.1161/CIRCULATIONAHA.109.849281. No abstract available.'}, {'pmid': '29275399', 'type': 'BACKGROUND', 'citation': 'Siontis GCM, Praz F, Lanz J, Vollenbroich R, Roten L, Stortecky S, Raber L, Windecker S, Pilgrim T. New-onset arrhythmias following transcatheter aortic valve implantation: a systematic review and meta-analysis. Heart. 2018 Jul;104(14):1208-1215. doi: 10.1136/heartjnl-2017-312310. Epub 2017 Dec 23.'}, {'pmid': '30031719', 'type': 'BACKGROUND', 'citation': 'Rodes-Cabau J, Urena M, Nombela-Franco L, Amat-Santos I, Kleiman N, Munoz-Garcia A, Atienza F, Serra V, Deyell MW, Veiga-Fernandez G, Masson JB, Canadas-Godoy V, Himbert D, Castrodeza J, Elizaga J, Francisco Pascual J, Webb JG, de la Torre JM, Asmarats L, Pelletier-Beaumont E, Philippon F. Arrhythmic Burden as Determined by Ambulatory Continuous Cardiac Monitoring in Patients With New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Replacement: The MARE Study. JACC Cardiovasc Interv. 2018 Aug 13;11(15):1495-1505. doi: 10.1016/j.jcin.2018.04.016. Epub 2018 Jul 18.'}, {'pmid': '7375971', 'type': 'BACKGROUND', 'citation': 'Mautner RK, Phillips JH. Atrioventricular and intraventricular conduction disturbances in aortic valvular disease. South Med J. 1980 May;73(5):572-8, 581. doi: 10.1097/00007611-198005000-00008.'}, {'pmid': '23075140', 'type': 'BACKGROUND', 'citation': 'Widgren V, Dencker M, Juhlin T, Platonov P, Willenheimer R. Aortic stenosis and mitral regurgitation as predictors of atrial fibrillation during 11 years of follow-up. BMC Cardiovasc Disord. 2012 Oct 18;12:92. doi: 10.1186/1471-2261-12-92.'}, {'pmid': '4013990', 'type': 'BACKGROUND', 'citation': 'MacMillan RM, Demorizi NM, Gessman LJ, Maranhao V. Correlates of prolonged HV conduction in aortic stenosis. Am Heart J. 1985 Jul;110(1 Pt 1):56-60. doi: 10.1016/0002-8703(85)90514-9.'}]}, 'descriptionModule': {'briefSummary': 'TAVI recipients exhibit a high burden of arrhythmic events early after the procedure. ECG continuous monitoring could be useful to diagnose and facilitate early implementation of specific therapeutic measures in these patients.', 'detailedDescription': "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 after hospital discharge. Following the TAVI procedure, continuous ECG monitoring will start just before hospital discharge and prolonged up to 4 weeks. There won't be any restriction regarding the type of valve and approach used for the TAVI procedure.\n\nAll type of arrhythmic events will be recorded, as well as the specific therapeutic measures implemented upon the diagnosis of the arrhythmic event.\n\nAnalyses of the CardioSTAT will be done at 2 and 4 weeks following hospital discharge. Clinical follow-up will be performed at 14 days (analysis of CardioSTAT® record), 28 days (analysis of CardioSTAT record), 1 year post-TAVI and yearly thereafter up to 5-year follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with severe aortic stenosis undergoing TAVI with either balloon or self-expandable valves.\n\nExclusion Criteria:\n\n* Failure to provide informed consent.\n* Prior or post-procedural pacemaker\n* In-hospital death\n* Logistic reasons precluding ECG monitoring within the 4 weeks after the procedure\n* Participation in another continuous ECG monitoring post-TAVI trial'}, 'identificationModule': {'nctId': 'NCT04298593', 'briefTitle': 'Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study', 'organization': {'class': 'OTHER', 'fullName': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval'}, 'officialTitle': 'Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study', 'orgStudyIdInfo': {'id': 'RECORD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ECG monitoring', 'description': 'All patient will be under telemetry', 'interventionNames': ['Device: Cardiostat']}], 'interventions': [{'name': 'Cardiostat', 'type': 'DEVICE', 'description': 'This is a prospective observational study including patients accepted by the heart team for a TAVI procedure. There will be no restriction regarding the type of valve and approach used for the TAVI procedure. Following the TAVI procedure, the patients will be under telemetry until hospital discharge and, at hospital discharge, they will be monitorized up to 4 more weeks using the CardioSTAT® device.', 'armGroupLabels': ['ECG monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4G5', 'city': 'Québec', 'country': 'Canada', 'facility': 'IUCPQ', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Principal investigator', 'investigatorFullName': 'Josep Rodes-Cabau', 'investigatorAffiliation': 'Institut universitaire de cardiologie et de pneumologie de Québec, University Laval'}}}}