Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT02341768
Status:
COMPLETED
Last Update Posted:
2020-08-17
First Post:
2015-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Device Functional Assessment of Real World ICD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Israel']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 2056}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-14', 'studyFirstSubmitDate': '2015-01-12', 'studyFirstSubmitQcDate': '2015-01-14', 'lastUpdatePostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate clinical and device functional information from "real world" ICD patient population following standard of care at participating centers w/in the different participating countries (Incidence of all death, device,cardiac related hospitalization)', 'timeFrame': '2 years', 'description': 'Incidence of all death, device and/or cardiac related hospitalization at 24 months post implant'}], 'secondaryOutcomes': [{'measure': 'Serious procedural complications or other SAE at implantation or hospital discharge. The data analyzed are those collected from the day of implantation to the day of hospital discharge, with an expected average of 1 week.', 'timeFrame': 'at implantation or hospital discharge', 'description': 'as reported by the sites on the AE eCRF'}, {'measure': 'The incidence of all death, device and/or cardiac related hospitalization at 12 months post implant (evaluated with a survival curve)', 'timeFrame': 'at 12 months', 'description': 'as reported by the sites with AE'}, {'measure': 'The predictors of mortality and cardiac related hospitalization at 12 and 24 months', 'timeFrame': 'at 12 and 24 months', 'description': 'as reported by the sites with AE and medical history information'}, {'measure': 'The predictors of appropriate or inappropriate therapies (ATP and shocks) at 12 and 24 months, as verified by a dedicated committee', 'timeFrame': 'at 12 and 24 months', 'description': 'based on therapies delivered recorder on device file, and verified by a dedicated committee'}, {'measure': "The evolution of the indication for implant according to guideline (based on the patient's medical history and reason for implant as reported by the investigators)", 'timeFrame': 'at implant', 'description': "based on the patient's medical history and reason for implant as reported by the investigators"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['clinical and device functional information', '"real world" ICD patient population'], 'conditions': ['Arrythmia', 'Implantable Cardioverter Defibrillator']}, 'descriptionModule': {'briefSummary': "The primary requirement of the implantable cardioverter defibrillator (ICD) is to preserve life by terminating life-threatening arrhythmias (VT/VF). The treatment options vary in terms of techniques and medical devices, based on the patient's condition.\n\nIt is extremely important in the clinical practice to identify which patients' subgroup benefits the most from the ICD therapy, which comorbidity has a major impact on the patients' prognosis, or which pre-intra-post procedural behaviors provoke less complications, and affect the patient's outcome (including prolonged or unwanted hospitalizations).", 'detailedDescription': 'For these reasons, it is very important to observe the clinical practice on a large variety of centers and countries, with the objective to collect long term safety and performance data in patients undergoing ICD/CRT-D device implantation (first implant, replacement or upgrade).\n\nThe safety and performance of the ICDs can be evaluated through the collection of multiple parameters such as, but not limited to:\n\n* Clinical parameters, like patient demographics and history, procedural and hospital discharge data, as well as the short and long term serious adverse events (death and hospitalization)\n* Device parameters, such as delivered shocks, ATP, or other device therapies\n\nWorldwide selected centers will be invited to participate in this prospective study and include their "real-world" patients treated with Sorin Group commercially available ICDs and CRT-Ds devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The aim of this study is to include all patients from a global "real world" (standard of care) population at participating centers and will reference the indication and the contra-indications specified in the guidelines and IFUs.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient Implanted (first implant, replacement, upgrade) with a Sorin Group ICD/CRT-D device, according to current available guidelines and IFU\n* Signed and dated informed consent (in accordance to local regulation)\n\nExclusion Criteria:\n\n* Already included in another clinical study that could confound the results of this study\n* Not available for routine follow-up visits\n* Minor age\n* Drug addiction or abuse'}, 'identificationModule': {'nctId': 'NCT02341768', 'acronym': 'CARAT', 'briefTitle': 'Clinical and Device Functional Assessment of Real World ICD Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'MicroPort CRM'}, 'officialTitle': 'Clinical and Device Functional Assessment of Real World ICD Patients', 'orgStudyIdInfo': {'id': 'RTSY03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ICD', 'type': 'DEVICE', 'description': 'ICD single, dual or triple chamber, upgrade, replacement or primo implant'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Feldkirchen bei Mattighofen', 'country': 'Austria', 'facility': 'LKH Feldkirch', 'geoPoint': {'lat': 48.06781, 'lon': 13.04476}}, {'city': 'Innsbruck', 'country': 'Austria', 'facility': 'LKH Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Linz', 'country': 'Austria', 'facility': 'Kepler Universitatsklinikum GmbH', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Pölten', 'country': 'Austria', 'facility': 'LKH St. Polten', 'geoPoint': {'lat': 46.73333, 'lon': 15.96667}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Edmonton', 'country': 'Canada', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Montreal', 'country': 'Canada', 'facility': 'HDM (CHUM) Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'country': 'Canada', 'facility': 'HSCM Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'country': 'Canada', 'facility': 'IUCPQ Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Québec', 'country': 'Canada', 'facility': 'Sherbrooke', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Fakultni Nemocnice Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Fakultni Nemocnice U svaté Anny v Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Fakultni Nemocnice Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Annecy', 'country': 'France', 'facility': 'CH Annecy Genevois', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Avignon', 'country': 'France', 'facility': 'Clinique Rhône Durance', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Brest', 'country': 'France', 'facility': 'CHU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Clamart', 'country': 'France', 'facility': 'H.I.A Percy', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Créteil', 'country': 'France', 'facility': 'CHU Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Jossigny', 'country': 'France', 'facility': 'CH de Marne la Vallée', 'geoPoint': {'lat': 48.83765, 'lon': 2.75432}}, {'city': 'Le Coudray', 'country': 'France', 'facility': 'Hôpital Louis Pasteur', 'geoPoint': {'lat': 48.42115, 'lon': 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'Universitätsklinikum Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'city': 'Markkleeberg', 'country': 'Germany', 'facility': 'Kardiologische Praxis', 'geoPoint': {'lat': 51.2755, 'lon': 12.36906}}, {'city': 'Neubrandenburg', 'country': 'Germany', 'facility': 'Dietrich Bonhoeffer Klinikum', 'geoPoint': {'lat': 53.55735, 'lon': 13.26105}}, {'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitatsklinikum', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Ospedale Garibaldi Centro', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Chieti', 'country': 'Italy', 'facility': 'Ospedale Pol SS Annunziata', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'city': 'Chioggia', 'country': 'Italy', 'facility': 'Presidio Ospedaliero di Chioggia', 'geoPoint': {'lat': 45.21857, 'lon': 12.27774}}, {'city': 'Lucca', 'country': 'Italy', 'facility': 'Ospital San Luca', 'geoPoint': {'lat': 43.84369, 'lon': 10.50447}}, {'city': 'Mirano', 'country': 'Italy', 'facility': 'Ospedale Civile', 'geoPoint': {'lat': 45.49458, 'lon': 12.10775}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Osp S Giovanni Bosco', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Ospedale Cardarelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Ospedale Policlinico Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Policlinico Casilino', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Teramo', 'country': 'Italy', 'facility': 'Osp. G. Mazzini', 'geoPoint': {'lat': 42.66123, 'lon': 13.69901}}, {'city': 'Trieste', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Ospedali Riuniti', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'city': 'Schiedam', 'country': 'Netherlands', 'facility': 'Vlietland Ziekenhuis', 'geoPoint': {'lat': 51.91917, 'lon': 4.38889}}, {'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala Klinieken', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}, {'city': 'Almada', 'country': 'Portugal', 'facility': 'Hospital Garcia de Orta', 'geoPoint': {'lat': 38.67902, 'lon': -9.1569}}, {'city': 'Amadora', 'country': 'Portugal', 'facility': 'Hospital Professor Doutor Fernando Fonseca', 'geoPoint': {'lat': 38.75382, 'lon': -9.23083}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'CHLC Hospital de Santa Marta', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'H. Santa Maria', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Banská Bystrica', 'country': 'Slovakia', 'facility': 'Susch Hospital', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Nusch Hospital', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Košice', 'country': 'Slovakia', 'facility': 'Vusch Hospital', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Majadahonda', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Oviedo', 'country': 'Spain', 'facility': 'Hospital Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'Hospital Son Llàtzer', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'H.U La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Vigo', 'country': 'Spain', 'facility': 'CHU de Vigo', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Fondazione Cardiocentro Ticino', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'city': 'Barnet', 'country': 'United Kingdom', 'facility': 'Barnet General Hospital', 'geoPoint': {'lat': 51.65, 'lon': -0.2}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Edgbaston', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Papworth Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Dorchester', 'country': 'United Kingdom', 'facility': 'Dorget County Hospital', 'geoPoint': {'lat': 50.71667, 'lon': -2.43333}}, {'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'city': 'Hereford', 'country': 'United Kingdom', 'facility': 'Wye Valley NHS Trust', 'geoPoint': {'lat': 52.05684, 'lon': -2.71482}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Glenfield Hospital', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Northampton', 'country': 'United Kingdom', 'facility': 'Northampton General Hospital', 'geoPoint': {'lat': 52.25, 'lon': -0.88333}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Northern General Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Javier Moreno, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Ramón y Cajal Ctra. de Colmenar Viejo km 9.100, 28034 Madrid, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MicroPort CRM', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}