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

Biotronik

Status: Terminated

Conditions: Ventricular Tachycardia

Treatments: Procedure: VT ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02501005

EP028

Details and patient eligibility

About

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.

Enrollment: 163 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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163 participants in 2 patient groups

Treatment Group 1 (TG1)

Experimental group

Description:

Prophylactic VT ablation prior to ICD implantation

Treatment:

Procedure: VT ablation

Treatment Group 2 (TG2)

Other group

Description:

ICD implantation and best medical care until the third appropriate ICD shock occurs and catheter ablation thereafter

Treatment:

Procedure: VT ablation