Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-23 @ 2:21 AM
Study NCT ID:
NCT00619593
Status:
COMPLETED
Last Update Posted:
2015-01-12
First Post:
2008-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survival of Patients With Primary Prophylactic ICD Indication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D014693', 'term': 'Ventricular Fibrillation'}], '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'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 504}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-09', 'studyFirstSubmitDate': '2008-02-11', 'studyFirstSubmitQcDate': '2008-02-20', 'lastUpdatePostDateStruct': {'date': '2015-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Sudden cardiac death', 'timeFrame': '12 months'}, {'measure': 'Non-sudden cardiac death', 'timeFrame': '12 months'}, {'measure': 'Risk of 1st heart failure hospitalization', 'timeFrame': '12 months'}, {'measure': 'No. of VT Storms (> 3 VT/24h)', 'timeFrame': '12 months'}, {'measure': 'No. of delivered ICD therapies', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart failure', 'Ventricular Fibrillation', 'Sudden cardiac death', 'Hospitalization due to heart failure', 'Implantable cardioverter-defibrillator', 'Risk of 1st heart failure hospitalization'], 'conditions': ['Primary Prevention', 'Tachycardia, Ventricular', 'Sudden Cardiac Death']}, 'descriptionModule': {'briefSummary': 'The MADIT-II trial has shown that patients with severely reduced left ventricular ejection fraction (LVEF) post myocardial infarction benefit from the implantable cardioverter-defibrillator (ICD). However, retrospective analyses of the MADIT-II data have revealed a significantly increased morbidity and mortality in patients with appropriate ICD therapy: Appropriate ICD therapy is associated with 3.3-fold increased all-cause mortality, and the risk of a first heart failure hospitalization is 90% higher after 1st appropriate ICD therapy. Hence, the 1st appropriate therapy might indicate the necessity and utility of further clinical diagnostics and therapy in these patients.\n\nThis trial is designed to (i) improve the knowledge of the group characteristics of patients suffering from 1st appropriate ICD therapy, (ii) but moreover to take additional therapeutic steps to reduce the mortality of this patient population.', 'detailedDescription': "The MADIT-II trial has shown that patients with severely reduced left ventricular ejection fraction (LVEF) post myocardial infarction benefit from the implantable cardioverter-defibrillator (ICD). However, retrospective analyses of the MADIT-II data have revealed a significantly increased morbidity and mortality in patients with appropriate ICD therapy: Appropriate ICD therapy is associated with 3.3-fold increased all-cause mortality, and the risk of a first heart failure hospitalization is 90% higher after 1st appropriate ICD therapy. Hence, the 1st appropriate therapy might indicate the necessity and utility of further clinical diagnostics and therapy in these patients.\n\nThis trial is designed to (i) improve the knowledge of the group characteristics of patients suffering from 1st appropriate ICD therapy, (ii) but moreover to take additional therapeutic steps to reduce the mortality of this patient population.\n\nAfter standard ICD implantation procedure, the following steps are performed at the pre-discharge follow-up:\n\n* Programming: VR-T: VVI 40 ppm, Onset 20%, Stability 20 ms\n* DR-T: DDD 50-60 ppm, activation of IRSplus and SMART\n* HF-T: DDD-BiV 50-60 ppm, achieve at least 85% biventricular resynchronisation, activation of SMART\n* All devices: VT zone as therapy zone, VF zone. Programming recommendations for VT/VF zones to standardize treatment:\n\n * VF zone: 200-250 bpm/ 300-240 ms, ATPoneshot ON\n * VT1 zone: 167-200 bpm/ 360-300 ms, ATP ON\n * VT2 zone: 120-167 bpm/ 500-360 ms, ATP ON\n* Activation of Home Monitoring (HM) and online registration for HM service\n\nStandard Follow-up: Timing and scope of follow-up in patients without episodes is to the physician's own discretion and should follow the standard clinical routine.\n\nFollow-up after 1st appropriate ICD therapy: Immediately after having received the 1st appropriate ICD therapy, the patients have to be called to the clinic for intensified clinical diagnostics and, if necessary or useful, intensified therapy. Standard ICD follow-up has to be started within 72 hours after 1st appropriate ICD therapy.\n\n* ICD interrogation\n* General health status (weight, BP, NYHA)\n* Laboratory tests (hemoglobin, Nt-proBNP, creatinine, GDF-15)\n* Echocardiography (LVEF, LVEDD, mitral regurgitation)\n* Non-invasive ischemia evaluation\n* Coronary angiography (if indicated by ischemia evaluation)\n* Upgrade to CRT, if indicated\n* Ventricular ablation (if indicated: VT storm, slow VT, bundle branch reentry)\n* 24 hrs ECG Holter (Heart rate variability)\n* Further treatment (if applicable)\n* Changes in ICD settings, or medication\n* Adverse events / adverse device effects\n\nFinal follow-up visit: For patients without appropriate ICD therapy, the final follow-up shall be performed 12 months after enrolment.\n\nFor patients with appropriate ICD therapy, the final follow-up shall be performed 12 months after 1st appropriate ICD therapy.\n\nThe final follow-up visit comprises:\n\n* ICD interrogation\n* General health status (weight, BP, NYHA)\n* Echocardiography (LVEF, LVEDD, mitral regurgitation)\n* Laboratory tests (hemoglobin, Nt-proBNP, creatinine, GDF-15)\n* 24 hrs ECG Holter (Heart rate variability)\n* Further treatment (if applicable)\n* Changes in ICD settings, or medication\n* Adverse events / adverse device effects"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for ICD implantation according to MADIT-II:\n\n * Myocardial infarction 30 days or more before implantation\n * LVEF of 30% or less within 3 months before implantation\n* Angiography within the preceding 12 months\n* The patient is willing and able to comply with the clinical investigation plan and has provided written informed consent\n\nExclusion Criteria:\n\n* Patients with contraindication for ICD implantation\n* Conventional ICD indication (i.e. other than MADIT-II)\n* Myocardial infarction within the past 30 days\n* Coronary revascularisation within the preceding 3 months (i.e., if revascularization has been performed wait at least 3 months until enrolment, given that no appropriate/ inappropriate ICD therapy has occured)\n* NYHA functional class IV\n* Unexplained syncope within 3 years\n* Advanced cerebrovascular disease\n* Life expectancy very probably below 12 months\n* Pregnant or breast-feeding women\n* Age \\< 18 years\n* Patients who are already enrolled in another study (therapy/intervention phase)'}, 'identificationModule': {'nctId': 'NCT00619593', 'acronym': 'SPIRIT-ICD', 'briefTitle': 'Survival of Patients With Primary Prophylactic ICD Indication', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'Survival of Patients With Primary Prophylactic ICD Indication, Provided With Intensified Care After 1st ICD Therapy', 'orgStudyIdInfo': {'id': 'TA079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Standard follow-up in patients without appropriate ICD therapy', 'interventionNames': ['Other: Standard follow-up']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Following 1st appropriate ICD therapy, the patients have to be called to the clinic for intensified clinical diagnostics and, if necessary or useful, intensified therapy.', 'interventionNames': ['Other: Intensified diagnostic and treatment measures following 1st appropriate ICD therapy']}], 'interventions': [{'name': 'Intensified diagnostic and treatment measures following 1st appropriate ICD therapy', 'type': 'OTHER', 'otherNames': ['Intensified diagnostic and treatment measures'], 'description': '* Assessment of general health status (weight, BP, NYHA)\n* Laboratory tests (hemoglobin, Nt-proBNP, creatinine, GDF-15)\n* Echocardiography (LVEF, LVEDD, mitral regurgitation)\n* Non-invasive ischemia evaluation\n* Coronary angiography (if indicated by ischemia evaluation)\n* Upgrade to CRT, if indicated\n* Ventricular ablation (if indicated: VT storm, slow VT, bundle branch reentry)\n* 24 hrs ECG Holter (Heart rate variability)\n* Further treatment (if applicable)\n* Changes in ICD settings, or medication', 'armGroupLabels': ['1']}, {'name': 'Standard follow-up', 'type': 'OTHER', 'description': 'Standard follow-up in patients without appropriate ICD therapy', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'A.ö. Krankenhaus der Stadt Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '3100', 'city': 'Sankt Pölten', 'country': 'Austria', 'facility': 'Landesklinikum St. Pölten', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}, {'zip': '1160', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Wilhelminenspital der Stadt Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '62500', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Brno Bohunice', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '65691', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Fakultni nemocnice u Svety Anny', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '77520', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'FN Olomouc, Inerni klinika', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '12000', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Online 24 S.R.O.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '1421', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Institute of clinical and experimental medicine', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'University Hospital RWTH Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '97616', 'city': 'Bad Neustadt an der Saale', 'country': 'Germany', 'facility': 'Herz- und Gefäss-Klinik GmbH Bad Neustadt', 'geoPoint': {'lat': 50.32174, 'lon': 10.20673}}, {'zip': '33604', 'city': 'Bielefeld', 'country': 'Germany', 'facility': 'Klinikum Bielefeld', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}, {'zip': '53105', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '53115', 'city': 'Bonn', 'country': 'Germany', 'facility': 'St. Marien Hospital', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '32756', 'city': 'Detmold', 'country': 'Germany', 'facility': 'Klinikum Detmold Lippe', 'geoPoint': {'lat': 51.93855, 'lon': 8.87318}}, {'zip': '44137', 'city': 'Dortmund', 'country': 'Germany', 'facility': 'Klinikum Mitte', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '01067', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Städtisches Klinikum Dresden-Friedrichstadt', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '40217', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Evangelisches Krankenhaus', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '41812', 'city': 'Erkelenz', 'country': 'Germany', 'facility': 'Hermann-Josef-Krankenhaus', 'geoPoint': {'lat': 51.07947, 'lon': 6.31531}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Justus Liebig Universität Gießen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '84034', 'city': 'Landshut', 'country': 'Germany', 'facility': 'Krankenhaus Landshut-Achdorf', 'geoPoint': {'lat': 48.52961, 'lon': 12.16179}}, {'zip': '41063', 'city': 'Mönchengladbach', 'country': 'Germany', 'facility': 'Krankenhaus St. Franziskus', 'geoPoint': {'lat': 51.18539, 'lon': 6.44172}}, {'zip': '33098', 'city': 'Paderborn', 'country': 'Germany', 'facility': 'St. Vincenz Krankenhaus', 'geoPoint': {'lat': 51.71905, 'lon': 8.75439}}, {'zip': '18055', 'city': 'Rostock', 'country': 'Germany', 'facility': 'University Hospital Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '59423', 'city': 'Unna', 'country': 'Germany', 'facility': 'Katharinenhospital', 'geoPoint': {'lat': 51.53795, 'lon': 7.68969}}, {'zip': '1122', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4012', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'The University of Medicine Debrecen', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Chaim Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '1002', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Latvian Center of Cardiology', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Health Waikato, Cardiology Department', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'zip': '95336', 'city': 'Lodz', 'country': 'Poland', 'facility': 'MULTI-MED PLUS Spolka z o.o', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '04-628', 'city': 'Warzawa', 'country': 'Poland', 'facility': 'Instytut Kardiologii'}, {'zip': '97401', 'city': 'Banská Bystrica', 'country': 'Slovakia', 'facility': 'Ssusch', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'zip': '833 48', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Kardiologická klinika', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '04001', 'city': 'Košice', 'country': 'Slovakia', 'facility': 'VUSCH East Slovak Cardiology Institute', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'H. Univ. La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Universitätsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Robert Hatala, Prof. MUDr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Národný ústav srdcových a cievnych chorôb, Kardiologická klinika, Pod Krásnou Hôrkou 1, 833 48 Bratislava, Slovakia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}