Ventricular Tachycardia
Conditions
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.
Interventions
PROCEDUREVT ablation
Catheter ablation of ventricular tachycardia
Sponsors
Biotronik SE & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 | 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. |
| Changes in quality of life / physical | 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. |
| 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. | — |
Countries
Germany
Outcome results
None listed