Preventive aBlation of vEntricular tachycaRdia in Patients With myocardiaL INfarction

Biotronik SE & Co. KG5 sites in 1 country163 target enrollmentJuly 20, 2015

ConditionsVentricular Tachycardia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ventricular Tachycardia
Sponsor: Biotronik SE & Co. KG
Enrollment: 163
Locations: 5
Primary Endpoint: 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)
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 20, 2015

End Date

July 20, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biotronik SE & Co. KG

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

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 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.)
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 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 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.)
Changes in quality of life / mental(12 months)
Changes in quality of life / physical(12 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 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.)