Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT02501005
Status:
TERMINATED
Last Update Posted:
2019-07-08
First Post:
2015-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'whyStopped': 'The study was stopped due to futility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-04', 'studyFirstSubmitDate': '2015-07-06', 'studyFirstSubmitQcDate': '2015-07-15', 'lastUpdatePostDateStruct': {'date': '2019-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first event comprising all-cause mortality, unplanned hospital admission for congestive heart failure and unplanned hospital admission for symptomatic ventricular tachycardia (VT)/ ventricular fibrillation (VF)', 'timeFrame': 'From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months.'}], 'secondaryOutcomes': [{'measure': 'Time to first sustained ventricular tachycardia (VT)/ ventricular fibrillation (VF)', 'timeFrame': 'From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months..'}, {'measure': 'Time to first appropriate implantable cardioverter-defibrillator (ICD) therapy', 'timeFrame': 'From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months.'}, {'measure': 'Time to first inappropriate implantable cardioverter-defibrillator (ICD) therapy', 'timeFrame': 'From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months.'}, {'measure': 'Time to all-cause mortality', 'timeFrame': 'From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months.'}, {'measure': 'Time to cardiac mortality', 'timeFrame': 'From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months.'}, {'measure': 'Time to first unplanned all-cause hospitalization', 'timeFrame': 'From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months.'}, {'measure': 'Time to first unplanned cardiac hospitalization', 'timeFrame': 'From randomization until official study end or drop-out, patients will be followed and assessed for primary endpoint events and Time-to-Event Outcome Measures for an expected average of 30 months.'}, {'measure': 'Changes in quality of life / mental', 'timeFrame': '12 months', 'description': 'This endpoint compares the changes in the mental component score of the Short Form-36 (SF-36) questionnaire from enrollment to the 12-months follow-up. Additionally, descriptive statistics is calculated: absolute scores at enrollment, 3-month follow-up, and 12-month follow-up, short-term changes in scores from enrollment to the 3-month follow-up.'}, {'measure': 'Changes in quality of life / physical', 'timeFrame': '12 months', 'description': 'This endpoint compares the changes in the physical component score of the Short Form-36 (SF-36) questionnaire from enrollment to the 12-months follow-up. Additionally, descriptive statistics is calculated: absolute scores at enrollment, 3-month follow-up, and 12-month follow-up, short-term changes in scores from enrollment to the 3-month follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ventricular Tachycardia']}, 'referencesModule': {'references': [{'pmid': '31072848', 'type': 'BACKGROUND', 'citation': 'Tilz RR, Kuck KH, Kaab S, Wegscheider K, Thiem A, Wenzel B, Willems S, Steven D. Rationale and design of BERLIN VT study: a multicenter randomised trial comparing preventive versus deferred ablation of ventricular tachycardia. BMJ Open. 2019 May 9;9(5):e022910. doi: 10.1136/bmjopen-2018-022910.'}, {'pmid': '32000514', 'type': 'DERIVED', 'citation': 'Willems S, Tilz RR, Steven D, Kaab S, Wegscheider K, Geller L, Meyer C, Heeger CH, Metzner A, Sinner MF, Schluter M, Nordbeck P, Eckardt L, Bogossian H, Sultan A, Wenzel B, Kuck KH; BERLIN VT Investigators. Preventive or Deferred Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy and Implantable Defibrillator (BERLIN VT): A Multicenter Randomized Trial. Circulation. 2020 Mar 31;141(13):1057-1067. doi: 10.1161/CIRCULATIONAHA.119.043400. Epub 2020 Jan 31.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/31072848', 'label': 'Design Paper'}]}, 'descriptionModule': {'briefSummary': 'The BERLIN VT study is designed to evaluate the impact of prophylactic ventricular tachycardia (VT) ablation on all-cause mortality and unplanned hospital admission for congestive heart failure or symptomatic ventricular tachycardia/ventricular fibrillation (VF) when compared to VT ablation after the third appropriate implantable cardioverter-defibrillator (ICD) shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. History of remote myocardial infarction\n2. Left ventricular ejection fraction ≥ 30 to ≤ 50 % as estimated by cardiac MRI, 3D-echocardiography or via ventriculography within 30 days before enrollment\n3. Documentation of sustained ventricular tachycardia (VT) by any kind of Electrocardiography (ECG) including 12 lead ECG, holter ECG, rhythm strip, event monitoring, event recorder or pacemaker within 30 days before enrollment\n4. Implantable cardioverter-defibrillator (ICD) indication for secondary prevention\n5. Patients who are planned to be implanted with BIOTRONIK ICDs (single, dual, triple chamber or DX device)\n6. Patient has provided written informed consent\n7. Patient accepts activation of Home Monitoring®\n\nExclusion Criteria:\n\n1. Age \\< 18 years or \\> 80 years\n2. Known arterial or venous thrombosis\n3. Class IV New York Heart Association (NYHA) heart failure\n4. Valvular heart disease or mechanical heart valve precluding access to the left ventricle\n5. Acute myocardial reinfarction or acute coronary syndrome\n6. Cardiac surgery involving cardiotomy within the past 2 months\n7. Patients requiring chronic renal dialysis\n8. Thrombocytopenia or coagulopathy\n9. Incessant VT or electrical storm\n10. Bundle branch reentry tachycardia as the presenting VT\n11. Pre-existing implantable cardioverter-defibrillator (ICD)\n12. Pregnancy or breast feeding women\n13. Acute illness or active systemic infection\n14. Other disease process likely to limit survival to less than 12 months\n15. Significant medical problem that in the opinion of the principal investigator would preclude enrollment in the study\n16. Unwillingness to participate or lack of availability for follow-up\n17. Participation in another interventional clinical investigation during the course of the study, i.e. the participation in a non-interventional clinical investigation is allowed.'}, 'identificationModule': {'nctId': 'NCT02501005', 'acronym': 'BERLIN VT', 'briefTitle': 'Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction', 'orgStudyIdInfo': {'id': 'EP028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group 1 (TG1)', 'description': 'Prophylactic VT ablation prior to ICD implantation', 'interventionNames': ['Procedure: VT ablation']}, {'type': 'OTHER', 'label': 'Treatment Group 2 (TG2)', 'description': 'ICD implantation and best medical care until the third appropriate ICD shock occurs and catheter ablation thereafter', 'interventionNames': ['Procedure: VT ablation']}], 'interventions': [{'name': 'VT ablation', 'type': 'PROCEDURE', 'description': 'Catheter ablation of ventricular tachycardia', 'armGroupLabels': ['Treatment Group 1 (TG1)', 'Treatment Group 2 (TG2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsklinikum Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinik St. Georg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitäres Herzzentrum Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein Campus Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '81377', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum der Universität München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'overallOfficials': [{'name': 'Karl-Heinz Kuck, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asklepios Klinik St. Georg, Hamburg (Germany)'}, {'name': 'Stephan Willems, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitäres Herzzentrum, Hamburg (Germany)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}