Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT02323503
Status:
COMPLETED
Last Update Posted:
2020-03-31
First Post:
2014-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 289}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2014-12-22', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of patients with ventricular tachycardia or ventricular fibrillation events, with appropriate therapies', 'timeFrame': 'After the device replacement and after a minimum of two years FU'}, {'measure': 'Rate of patients with inappropriate therapies/diagnosis', 'timeFrame': 'After the device replacement and after a minimum of two years FU'}, {'measure': 'Baseline factor predictors of ventricular events', 'timeFrame': 'After the device replacement and after a minimum of two years FU'}, {'measure': 'Serious adverse events related to ventricular events / inappropriate therapies', 'timeFrame': 'After the device replacement and after a minimum of two years FU'}], 'primaryOutcomes': [{'measure': 'Assess the rate of patients with at least one sustained VTA after replacement', 'timeFrame': 'up to two years'}], 'secondaryOutcomes': [{'measure': 'Rate of patients with at least one VTA for 4 specific subgroups', 'timeFrame': 'After the device replacement and after a minimum of two years follow-up (FU)', 'description': 'Grp R\\[1-4\\]: LVEF ≥40% / \\<40% at the time of replacement and with / without previous VTA during the lifetime of their first CRT-D device'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CRT-D', 'replacement', 'primary prevention', 'ventricular tachyarrhythmias'], 'conditions': ['Cardiac Resynchronization', 'Biventricular Pacemakers, Artificial', 'Cardioverter-Defibrillators, Implantable', 'Device Replacement']}, 'referencesModule': {'references': [{'pmid': '36459310', 'type': 'DERIVED', 'citation': 'Gras D, Clementy N, Ploux S, Guyomar Y, Legallois D, Segreti L, Blangy H, Laurent G, Bizeau O, Fauquembergue S, Lazarus A; BioCONTINUE study Investigators. CRT-D replacement strategy: results of the BioCONTINUE study. J Interv Card Electrophysiol. 2023 Aug;66(5):1201-1209. doi: 10.1007/s10840-022-01440-5. Epub 2022 Dec 2.'}]}, 'descriptionModule': {'briefSummary': 'Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) \\<35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for defibrillator back-up after an event-free first CRT-D service-life for patients with improved LVEF is a controversy question.\n\n80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention do not experience VTA during the life-time of their first device.\n\nSo, regarding patients implanted with a CRT-D for primary prevention at the time of first implantation, the question is will they experience VTA after their device replacement by another CRT-D.', 'detailedDescription': 'The objective of this study is to describe, in a population of patients who had a primary prevention ICD indication at first implantation of a CRT-D, the relevance defibrillator back-up after the replacement of the first CRT-D. For that, the rate of patients with at least one sustained VTA detected by the CRT-D or a conventional surface ECG will be assessed after the device replacement.\n\nFurthermore, the association between the baseline characteristics of the CRT-D population after replacement and the risk of subsequent VTA will be explored after a minimum of two years FU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients initially implanted with a CRT-D (cardiac resynchronization therapy with defibrillator) device for primary prevention indication for defibrillation, requiring a device replacement by another CRT-D because of battery depletion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with primary prevention indication for defibrillation at the time of the first CRT-D implantation\n* Patient implanted as first replacement by a CRT-D device (CRT-D by CRT-D)\n* Lifetime of the previous CRT-D \\> 3 years\n* Patient willing and able to comply with the protocol and who has provided written informed consent\n* Patient whose medical situation is stable.\n\nExclusion Criteria:\n\n* Patient with an ICD lead under advisory (e.g. Fidelis lead)\n* Right or left ventricular leads exchange during CRT-D replacement\n* Non functional atrial (except for patient with chronic AF) or right/left ventricular leads\n* Life expectancy \\< 1 year\n* Age \\< 18 years\n* Pregnant woman or woman who plan to become pregnant during the trial\n* Participation in another interventional clinical study'}, 'identificationModule': {'nctId': 'NCT02323503', 'acronym': 'BioCONTINUE', 'briefTitle': 'Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication', 'orgStudyIdInfo': {'id': 'CR018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CRT-D device replacement', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalst', 'country': 'Belgium', 'facility': 'OLV Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Annecy', 'country': 'France', 'facility': "CH d'Annecy", 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Brest', 'country': 'France', 'facility': 'Hôpital de la Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Montpied', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Dijon', 'country': 'France', 'facility': 'CH Du Bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lomme', 'country': 'France', 'facility': 'CH Saint Philibert', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Cliniques du Tonkin, de la Sauvegarde et Protestante', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Clinique Clairval', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Metz', 'country': 'France', 'facility': 'Hôpital Mercy', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nancy', 'country': 'France', 'facility': 'CHU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Nouvelles Cliniques Nantaises', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'facility': 'CH de la Pitié Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pessac', 'country': 'France', 'facility': 'CHU Pessac', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU Hôpital CHarles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CH de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '31403', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Bad Rothenfelde', 'country': 'Germany', 'facility': 'Schuechtermann-Klinik', 'geoPoint': {'lat': 52.11667, 'lon': 8.16667}}, {'city': 'Brandenburg', 'country': 'Germany', 'facility': 'Stadtisches Klinikum Brandenburg', 'geoPoint': {'lat': 52.41667, 'lon': 12.55}}, {'city': 'Ratzeburg', 'country': 'Germany', 'facility': 'DRK-Krankenhaus Moelln Ratzeburg', 'geoPoint': {'lat': 53.69965, 'lon': 10.77256}}, {'city': 'Rostock', 'country': 'Germany', 'facility': 'Cardiological Praxis', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Ashkelon', 'country': 'Israel', 'facility': 'Barzilai Medical Center', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}, {'city': 'Lido di Camaiore', 'country': 'Italy', 'facility': 'Ospedale Versilia', 'geoPoint': {'lat': 43.90012, 'lon': 10.2269}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Clinica Mediterranea', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Pisa', 'country': 'Italy', 'facility': 'Ospedale Santa Chiara', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital de Santa Maria', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital de Santa Marta', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Burgos', 'country': 'Spain', 'facility': 'Hospital Universitario de Burgos', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}], 'overallOfficials': [{'name': 'Daniel DG Gras, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nouvelles Cliniques Nantaises, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}