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Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction (BERLIN VT)

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ClinicalTrials.gov Identifier: NCT02501005
Recruitment Status : Terminated (The study was stopped due to futility)
First Posted : July 17, 2015
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Procedure: VT ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction
Actual Study Start Date : July 20, 2015
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : July 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Treatment Group 1 (TG1)
Prophylactic VT ablation prior to ICD implantation
Procedure: VT ablation
Catheter ablation of ventricular tachycardia

Treatment Group 2 (TG2)
ICD implantation and best medical care until the third appropriate ICD shock occurs and catheter ablation thereafter
Procedure: VT ablation
Catheter ablation of ventricular tachycardia




Primary Outcome Measures :
  1. 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) [ Time Frame: 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. ]

Secondary Outcome Measures :
  1. Time to first sustained ventricular tachycardia (VT)/ ventricular fibrillation (VF) [ Time Frame: 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.. ]
  2. Time to first appropriate implantable cardioverter-defibrillator (ICD) therapy [ Time Frame: 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. ]
  3. Time to first inappropriate implantable cardioverter-defibrillator (ICD) therapy [ Time Frame: 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. ]
  4. Time to all-cause mortality [ Time Frame: 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. ]
  5. Time to cardiac mortality [ Time Frame: 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. ]
  6. Time to first unplanned all-cause hospitalization [ Time Frame: 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. ]
  7. Time to first unplanned cardiac hospitalization [ Time Frame: 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. ]
  8. Changes in quality of life / mental [ Time Frame: 12 months ]
    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.

  9. Changes in quality of life / physical [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. History of remote myocardial infarction
  2. Left ventricular ejection fraction ≥ 30 to ≤ 50 % as estimated by cardiac MRI, 3D-echocardiography or via ventriculography within 30 days before enrollment
  3. 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
  4. Implantable cardioverter-defibrillator (ICD) indication for secondary prevention
  5. Patients who are planned to be implanted with BIOTRONIK ICDs (single, dual, triple chamber or DX device)
  6. Patient has provided written informed consent
  7. Patient accepts activation of Home Monitoring®

Exclusion Criteria:

  1. Age < 18 years or > 80 years
  2. Known arterial or venous thrombosis
  3. Class IV New York Heart Association (NYHA) heart failure
  4. Valvular heart disease or mechanical heart valve precluding access to the left ventricle
  5. Acute myocardial reinfarction or acute coronary syndrome
  6. Cardiac surgery involving cardiotomy within the past 2 months
  7. Patients requiring chronic renal dialysis
  8. Thrombocytopenia or coagulopathy
  9. Incessant VT or electrical storm
  10. Bundle branch reentry tachycardia as the presenting VT
  11. Pre-existing implantable cardioverter-defibrillator (ICD)
  12. Pregnancy or breast feeding women
  13. Acute illness or active systemic infection
  14. Other disease process likely to limit survival to less than 12 months
  15. Significant medical problem that in the opinion of the principal investigator would preclude enrollment in the study
  16. Unwillingness to participate or lack of availability for follow-up
  17. Participation in another interventional clinical investigation during the course of the study, i.e. the participation in a non-interventional clinical investigation is allowed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501005


Locations
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Germany
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Universitäres Herzzentrum Hamburg
Hamburg, Germany, 20246
Universitätsklinikum Köln
Köln, Germany, 50937
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck, Germany, 23538
Klinikum der Universität München
München, Germany, 81377
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
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Principal Investigator: Karl-Heinz Kuck, Prof. Asklepios Klinik St. Georg, Hamburg (Germany)
Study Chair: Stephan Willems, Prof. Universitäres Herzzentrum, Hamburg (Germany)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT02501005     History of Changes
Other Study ID Numbers: EP028
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Tachycardia
Tachycardia, Ventricular
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease