Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-30 @ 8:09 PM
Study NCT ID:
NCT00729703
Status:
COMPLETED
Last Update Posted:
2015-01-13
First Post:
2008-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013610', 'term': 'Tachycardia'}], 'ancestors': [{'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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 462}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-12', 'studyFirstSubmitDate': '2008-08-04', 'studyFirstSubmitQcDate': '2008-08-06', 'lastUpdatePostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The first part is the time to first occurrence of inappropriate ICD shock therapy. The second part is the composite endpoint of time to first occurrence of death (all causes)or Hospitalizations due to cardio-vascular event.', 'timeFrame': 'implant, 3 months, 9 months, 15 months, 21 months and 27 months'}], 'secondaryOutcomes': [{'measure': 'all cause mortality and cardio-vascular related mortality', 'timeFrame': '27 months follow up'}, {'measure': 'Hospitalizations due to cardio-vascular event (specified for each type of event)', 'timeFrame': '27 months follow up'}, {'measure': 'Time to first occurrence of inappropriate ICD shock therapy', 'timeFrame': '27 months follow up'}, {'measure': 'Evaluation of the impact of the different therapies on quality of life and heart failure status', 'timeFrame': '27 months follow up'}, {'measure': 'Sensitivity and specificity for VT/SVT discrimination for the first 100 patients in each group.', 'timeFrame': '27 months'}, {'measure': 'Inappropriate overall device reactions defined by inappropriate shock and/or ATP therapy or inappropriate therapy delay/inhibition > 2 minutes on VTs', 'timeFrame': '27 months'}, {'measure': 'time to first documented AF occurrence and number of patients moving into permanent or persistent AF', 'timeFrame': '27 months follow up'}, {'measure': 'Cardiac dimensions obtained by echo evaluation for a subset of patients of both groups', 'timeFrame': 'Baseline and 27 months'}, {'measure': 'Slow VT incidence', 'timeFrame': '27 months'}, {'measure': 'Unscheduled visits and hospitalizations due to slow VT', 'timeFrame': '27 months follow up'}, {'measure': 'System related complications including lead dislodgements, exit block, oversensing which requires programming corrections, infections, complications which require reintervention', 'timeFrame': '27 months follow up'}, {'measure': 'Cumulative percentage of ventricular pacing and proportion of patients with 0% V pacing.', 'timeFrame': '27 months follow up'}, {'measure': 'Overall success rate of ATP in the FVT zone', 'timeFrame': '27 months'}, {'measure': 'Cost effectiveness of applied ICD therapy', 'timeFrame': '27 months'}, {'measure': 'PPV and NPV for Tvar risk stratification', 'timeFrame': '27 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ICD', 'Minimized', 'ventricular', 'pacing', 'indication', 'Clinical outcome', 'Inappropriate shock'], 'conditions': ['Tachycardia']}, 'referencesModule': {'references': [{'pmid': '20487351', 'type': 'BACKGROUND', 'citation': 'Kolb C, Tzeis S, Sturmer M, Babuty D, Schwab JO, Mantovani G, Janko S, Aime E, Ocklenburg R, Sick P. Rationale and design of the OPTION study: optimal antitachycardia therapy in ICD patients without pacing indications. Pacing Clin Electrophysiol. 2010 Sep;33(9):1141-8. doi: 10.1111/j.1540-8159.2010.02790.x.'}, {'pmid': '25282033', 'type': 'RESULT', 'citation': 'Kolb C, Sturmer M, Sick P, Reif S, Davy JM, Molon G, Schwab JO, Mantovani G, Dan D, Lennerz C, Borri-Brunetto A, Babuty D. Reduced risk for inappropriate implantable cardioverter-defibrillator shocks with dual-chamber therapy compared with single-chamber therapy: results of the randomized OPTION study. JACC Heart Fail. 2014 Dec;2(6):611-9. doi: 10.1016/j.jchf.2014.05.015. Epub 2014 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and mortality and inadequate therapy in medically stable, ICD-indicated patients with impaired left ventricular function (LVEF ≤ 40%) who do not have pacing indications and no indication for Cardiac Resynchronization Therapy (CRT). It compares a new pacing mode avoiding ventricular stimulation when not needed combined with dual chamber detection with a pure ventricular back up pacing and single chamber detection criteria with pure ventricular back up pacing. Therapies are compared in a prospective, randomized, single-blinded, parallel trial with a 24-month randomized treatment period. Randomization follows a 1:1 ratio. ICD therapy is enabled for all patients throughout the study. All patients receive optimal drug therapy for arrhythmia and heart failure treatment.', 'detailedDescription': 'All patients will receive an implantable cardioverter defibrillator OVATIO™ DR model 6550 or a later Sorin Group device offering the same functions. After Enrolment visit but before implant, patients will be randomized in two arms according to the parallel study design. Whenever possible before implant there will be the first Holter recording for the Tvar risk stratification procedure. In case Tvar recording could not be performed before implant it has to be performed before patient leaves the hospital post implant in unpaced rhythm.\n\nThe dual-chamber arm will be programmed to 3 detection zones with PARAD+ activated.\n\nThe TDI for the slow VT zone will be set to 500 ms (120 bpm - or in case the resting rate is higher than 90 bpm it is recommended to adjust this parameter to: resting rate + 30 bpm) and at least one ATP program activated as specified in table 1.\n\nA VT zone with a TDI of 353 ms (170 bpm) in case of no history of VT or a TDI cycle length equalling slowest documented VT interval (spontaneous or induced) plus 50 ms is required. In this 2nd VT zone therapies need to be activated in this group.\n\nAAIsafeR2 mode will be activated with a basic rate of 60 bpm. The single-chamber arm will be programmed to optimal detection with Acceleration (Onset), Stability and Long Cycle Search (VTLC) activated. A VT zone is requested in this group, with the same programming procedures as described above. Therapies will be set according to the clinical judgment of the participating investigators but a Slow VT-zone with TDI 500 ms in monitoring setting at least is required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has been prescribed the implantation for an ICD system accordingly to the relevant currently-approved ACC/AHA guidelines 1 or ESC guidelines 35 or any relevant currently-approved local guidelines for the implantation of an ICD-system\n* Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) ≤ 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.\n* An optimal (as determined by the enrolling physician) medical regimen.\n* Patient has received all relevant information on the study, and has signed and dated a consent form.\n\nExclusion Criteria:\n\n* Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.\n* Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.\n* Any contraindication for ICD therapy and the implant of a dual chamber ICD.\n* ICD replacement\n* Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.\n* A PR interval \\> 250 ms or AR interval \\> 300 ms measured at implant.\n* Hypertrophic obstructive cardiomyopathy.\n* Acute myocarditis.\n* Unstable coronary symptoms or myocardial infarction within the last month.\n* Recent (within the last month) or planned cardiac revascularization or coronary angioplasty.\n* Recently performed (in the last month) or planned cardiac surgery\n* Already included in another clinical study.\n* Life expectancy less than 24 months.\n* Inability to understand the purpose of the study or refusal to cooperate.\n* Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization.\n* Unavailability for scheduled follow-up at the implanting or cooperating center.\n* Age of less than 18 years.\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00729703', 'acronym': 'OPTION', 'briefTitle': 'Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications', 'organization': {'class': 'INDUSTRY', 'fullName': 'LivaNova'}, 'officialTitle': 'Optimal Antitachycardia Therapy in ICD Patients Without Pacing Indications', 'orgStudyIdInfo': {'id': 'OPTION - ITAC03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Dual-chamber detection and activated treatment (at least ATP) in the slow VT-zone plus activated AAIsafeR pacing (basic rate 60 bpm).', 'interventionNames': ['Device: Ovatio DR 6550']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Single-chamber ICD following clinical practice but with a monitoring zone active to allow the documentation of all occurring ventricular arrhythmias', 'interventionNames': ['Device: OVATIO DR 6550']}], 'interventions': [{'name': 'Ovatio DR 6550', 'type': 'DEVICE', 'description': 'Dual-chamber ICD therapy with minimized ventricular pacing', 'armGroupLabels': ['1']}, {'name': 'OVATIO DR 6550', 'type': 'DEVICE', 'description': 'Single-chamber device therapy with settings which are common in clinical practice.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Hospital Research Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30301', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Va Medical Center', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '70471', 'city': 'Mandeville', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Southern Medical Research, Llc', 'geoPoint': {'lat': 30.35825, 'lon': -90.06563}}, {'zip': '43128', 'city': 'Jeffersonville', 'state': 'Ohio', 'country': 'United States', 'facility': 'River City Cardiology', 'geoPoint': {'lat': 39.65367, 'lon': -83.56381}}, {'zip': '29501', 'city': 'Florence', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Pee Dee Cardiology', 'geoPoint': {'lat': 34.19543, 'lon': -79.76256}}, {'zip': '2600', 'city': 'Antwepen', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis - Antwepen'}, {'zip': '9050', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Kliniek Maria Middelares - Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3500. 64', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Heart Center Virga Jesse Ziekenhuis - Hasselt', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': 'H4Y 1H1', 'city': 'Montreal', 'country': 'Canada', 'facility': 'CHUM Hotel-Dieu', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'country': 'Canada', 'facility': 'Hôpital Sacré Coeur', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'Centre Hospitalier General', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': "CHU Le Haut L'Evêque", 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Hôpital Michallon Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '78150', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'Clinique De Parly II', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'city': 'Le Mans', 'country': 'France', 'facility': 'Clinique les sources', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Lomme', 'country': 'France', 'facility': 'CH ST Philibert', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}, {'zip': '69000', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital St Joseph', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '34294', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hopital Arnaud De Villeneuve', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75016', 'city': 'Paris', 'country': 'France', 'facility': 'Clinique Bizet', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '64000', 'city': 'Pau', 'country': 'France', 'facility': 'CH Pau', 'geoPoint': {'lat': 43.31117, 'lon': -0.35583}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Purpan Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Bad Bevensen', 'country': 'Germany', 'facility': 'Herzkreislaufklinik', 'geoPoint': {'lat': 53.07923, 'lon': 10.58129}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'facility': 'Kerckhoff Klinik', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Campus Virchow', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätskliniken Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '96465', 'city': 'Coburg', 'country': 'Germany', 'facility': 'Klinikum Coburg', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'zip': '82467', 'city': 'Garmisch-Partenkirchen', 'country': 'Germany', 'facility': 'Klinikum Garmisch-Partenkirchen', 'geoPoint': {'lat': 47.49209, 'lon': 11.09576}}, {'zip': '2100', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Homburg', 'country': 'Germany', 'facility': 'Universität des Saarlandes', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '23501', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitatsklinikum Schleswig-Holstein Campus Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '80337', 'city': 'München', 'country': 'Germany', 'facility': 'Kardiologische Gemeinschaftspraxis', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '81000', 'city': 'München', 'country': 'Germany', 'facility': 'Universitatsklinikum Grosshadern', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'München', 'country': 'Germany', 'facility': 'DHZ Munchen', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'München', 'country': 'Germany', 'facility': 'Klinikum Bogenhausen', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'München', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Uniklinik Munster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '93047', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Klinikum der Universität Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '93047', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Krankenhaus der Barmherzigen Brüder', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitätsklinik Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '20033', 'city': 'Desio', 'country': 'Italy', 'facility': 'Ospedale Civile', 'geoPoint': {'lat': 45.61831, 'lon': 9.20249}}, {'city': 'Negrar', 'country': 'Italy', 'facility': 'Ospedale Sacro Cuore Don Calabria', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Casa Di Cura Citta Di Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'San Donato', 'country': 'Italy', 'facility': 'Policlinico San Donato', 'geoPoint': {'lat': 45.08201, 'lon': 7.66485}}, {'zip': '20097', 'city': 'San Donato Milanese', 'country': 'Italy', 'facility': 'Ospedale Clinicizzato San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}, {'zip': '1060', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwen Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Almada', 'country': 'Portugal', 'facility': 'Hospital Garcia de Orta', 'geoPoint': {'lat': 38.67902, 'lon': -9.1569}}, {'city': 'Guimarães', 'country': 'Portugal', 'facility': 'Hospital Senhora da Oliveira', 'geoPoint': {'lat': 41.44443, 'lon': -8.29619}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'St Peters Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'TA1 4DY', 'city': 'Taunton', 'country': 'United Kingdom', 'facility': 'Musgrove Park Hospltal', 'geoPoint': {'lat': 51.01494, 'lon': -3.10293}}, {'zip': 'NR20 4LB', 'city': 'Worthing', 'country': 'United Kingdom', 'facility': 'Worthing And Southlands Hospital', 'geoPoint': {'lat': 50.81795, 'lon': -0.37538}}], 'overallOfficials': [{'name': 'Kolb', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deutsches Herzzentrum München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LivaNova', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}