Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction

Study Overview
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Brief Summary
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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.

Official Title
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Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Procedure: VT ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of remote myocardial infarction Left ventricular ejection fraction ≥ 30 to ≤ 50 % as estimated by cardiac MRI, 3D-echocardiography or via ventriculography within 30 days before enrollment 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 Implantable cardioverter-defibrillator (ICD) indication for secondary prevention Patients who are planned to be implanted with BIOTRONIK ICDs (single, dual, triple chamber or DX device) Patient has provided written informed consent Patient accepts activation of Home Monitoring® Exclusion Criteria: Age < 18 years or > 80 years Known arterial or venous thrombosis Class IV New York Heart Association (NYHA) heart failure Valvular heart disease or mechanical heart valve precluding access to the left ventricle Acute myocardial reinfarction or acute coronary syndrome Cardiac surgery involving cardiotomy within the past 2 months Patients requiring chronic renal dialysis Thrombocytopenia or coagulopathy Incessant VT or electrical storm Bundle branch reentry tachycardia as the presenting VT Pre-existing implantable cardioverter-defibrillator (ICD) Pregnancy or breast feeding women Acute illness or active systemic infection Other disease process likely to limit survival to less than 12 months Significant medical problem that in the opinion of the principal investigator would preclude enrollment in the study Unwillingness to participate or lack of availability for follow-up Participation in another interventional clinical investigation during the course of the study, i.e. the participation in a non-interventional clinical investigation is allowed.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group 1 (TG1)<br>Prophylactic VT ablation prior to ICD implantation | Procedure: VT ablation<br>* Catheter ablation of ventricular tachycardia<br>|
| Other: Treatment Group 2 (TG2)<br>ICD implantation and best medical care until the third appropriate ICD shock occurs and catheter ablation thereafter | Procedure: VT ablation<br>* Catheter ablation of ventricular tachycardia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first sustained ventricular tachycardia (VT)/ ventricular fibrillation (VF) |  | 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.. | 
| Time to first appropriate implantable cardioverter-defibrillator (ICD) therapy |  | 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. | 
| Time to first inappropriate implantable cardioverter-defibrillator (ICD) therapy |  | 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. | 
| Time to all-cause mortality |  | 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. | 
| Time to cardiac mortality |  | 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. | 
| Time to first unplanned all-cause hospitalization |  | 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. | 
| Time to first unplanned cardiac hospitalization |  | 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. | 
| Changes in quality of life / mental | 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. | 12 months | 
| Changes in quality of life / physical | 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. | 12 months |