Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT00729235
Status:
COMPLETED
Last Update Posted:
2011-12-22
First Post:
2008-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biventricular Tachycardias Outcome Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 481}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-21', 'studyFirstSubmitDate': '2008-08-04', 'studyFirstSubmitQcDate': '2008-08-06', 'lastUpdatePostDateStruct': {'date': '2011-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of slow ventricular tachycardias (Slow VTs) in CRT-ICD pts;', 'timeFrame': '24 months'}, {'measure': 'ATP therapy efficacy on slow VTs conversion.', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Efficacy of ATP therapies on Slow VTs according to therapy setting (delivery in LV only, in RV only, or in LV+RV)', 'timeFrame': '24 months'}, {'measure': 'Tvar risk stratification', 'timeFrame': '24 months'}, {'measure': '"unscheduled visits" or "hospital re-admissions" due to slow VTs;', 'timeFrame': '24 months'}, {'measure': 'Incidence of adverse events (AEs) in the studied population', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Slow VT, CRT-D, ATP therapy', 'Incidence', 'of slow VTs', 'in CRT-D patients', 'Clinical', 'relevance', 'treatment', 'VTs', 'during', '2-years', 'follow-up'], 'conditions': ['Biventricular Tachycardias']}, 'descriptionModule': {'briefSummary': "This clinical investigation is a device-based open, prospective, multicenter two-arm randomized trial, comparing patients who are treated in the slow VT zone versus patients who are not treated in that zone.\n\nThe device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and health authorities will be informed prior to any use of a newer device if applicable.\n\nAll patients will have a 3-zone detection configuration programmed. The slow VT zone will be defined by programming the detection parameters as follows:\n\n* Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we recommend to adjust this parameter to: resting rate + 30 bpm)\n* VT detection rate: 150 bpm\n\nPARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones.\n\nThe Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF are also left to the investigator's judgment.\n\nPatients will be randomized at implant to have the slow VT zone programmed as a monitoring zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm). The randomization table will be generated by Sorin Group/ELA Medical."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has been prescribed the implantation or replacement of a CRT-ICD system accordingly to the relevant currently-approved ACC/AHA15 (August 2005, Appendix §M.10) or ESC 16 (Update 2005, Appendix § M.11) guidelines or any relevant currently-approved local guidelines for the implantation or replacement of CRT-ICD.\n* Patient has signed a consent form after he/she received the appropriate and mandatory information.\n\nExclusion Criteria:\n\n* Clinical history of symptomatic or not symptomatic slow VT;\n* Permanent Atrial Fibrillation (AF);\n* Any contraindication to the implant or replacement of CRT-ICD;\n* Pt is unable to attend the scheduled f-up visits at the implanting Centre;\n* Pt is already included in another ongoing clinical study;\n* Pt is unable to understand the objectives of the ITAC04 study;\n* Pt refuses to cooperate;\n* Pt is unable or refuses to provide informed consent;\n* Pt is minor (less than 18-year old);\n* Pt has life expectancy of less than 1 year;\n* Pt is pregnant.'}, 'identificationModule': {'nctId': 'NCT00729235', 'acronym': 'BITAC', 'briefTitle': 'Biventricular Tachycardias Outcome Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'LivaNova'}, 'officialTitle': 'Biventricular Tachycardias Outcome Trial', 'orgStudyIdInfo': {'id': 'BITAC - ITAC04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)', 'interventionNames': ['Device: Ovatio CRT 6750']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Slow VT zone programmed with ATP therapies (therapy arm).', 'interventionNames': ['Device: Ovatio CRT 6750']}], 'interventions': [{'name': 'Ovatio CRT 6750', 'type': 'DEVICE', 'description': 'Slow VT zone programmed as a "Monitoring" zone (Monitoring arm)', 'armGroupLabels': ['1']}, {'name': 'Ovatio CRT 6750', 'type': 'DEVICE', 'description': 'Slow VT zone programmed with ATP therapies (therapy arm).', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2060', 'city': 'Antwepen', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis'}, {'zip': 'T5A 0A1', 'city': 'Edmonton', 'country': 'Canada', 'facility': 'Grey-Nuns Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T5A 0A1', 'city': 'Edmonton', 'country': 'Canada', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'G1R 4E4', 'city': 'Québec', 'country': 'Canada', 'facility': 'Laval UH, Ste Foy', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Albi', 'country': 'France', 'facility': 'CH Albi', 'geoPoint': {'lat': 43.9298, 'lon': 2.148}}, {'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'CH Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Antony', 'country': 'France', 'facility': "Hôpital privé d'Antony", 'geoPoint': {'lat': 48.75329, 'lon': 2.29668}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Haut Lévèque', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Brest', 'country': 'France', 'facility': 'Hôpital de la Cavalle Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Le Chesnay', 'country': 'France', 'facility': 'Clinique de Parly II', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'city': 'Lomme', 'country': 'France', 'facility': 'CH St Philibert', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU Hopital La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13000', 'city': 'Marseille', 'country': 'France', 'facility': 'CHU Hôpital Nord - 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