Rationale and design of BERLIN VT study: a multicenter randomised trial comparing preventive versus deferred ablation of ventricular tachycardia

TY - JOUR

T1 - Rationale and design of BERLIN VT study: a multicenter randomised trial comparing preventive versus deferred ablation of ventricular tachycardia

AU - Tilz, Roland Richard

AU - Kuck, Karl-Heinz

AU - Kääb, Stephan

AU - Wegscheider, Karl

AU - Thiem, Annette

AU - Wenzel, Beate

AU - Willems, Stephan

AU - Steven, Daniel

N1 - © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2019/5/9

Y1 - 2019/5/9

N2 - INTRODUCTION: Catheter ablation (CA) has shown to effectively reduce the burden of ventricular tachycardia in patients with implanted cardioverter-defibrillator (ICD). However, in patients with ICD implantation for secondary prevention of ventricular tachycardia (VT), the appropriate time point of CA and its effect on mortality and heart failure progression remains a matter of debate.METHODS AND ANALYSIS: We present the design of the ongoing preventive aB lation of vE ntriculartachyca R dia in patients with myocardia L IN farction (BERLIN VT) study that aims to prospectively enrol 208 patients with a stable ischaemic cardiomyopathy, a left ventricular ejection fraction of 30% to 50% and documented ventricular tachycardia. Patients will be 1:1 randomised to undergo CA at the time of ICD implantation or CA after the third appropriate ICD shock for ventricular tachycardia. ICD implantation will be performed in all patients. The primary endpoint is defined as the time to first event comprising all-cause mortality and unplanned hospital admission for congestive heart failure or for symptomatic VT/ventricular fibrillation. The patients will be followed until study termination according to the event driven design. Completion of enrolment is expected for mid of 2019.ETHICS AND DISSEMINATION: The study had been approved by the "Ethik-kommission der Landesärztekammer Hamburg" as well as the local institutional review boards for each of the participation sites. The results of the trial will be published in peer-reviewed journals TRIAL REGISTRATION NUMBER: NCT02501005.

AB - INTRODUCTION: Catheter ablation (CA) has shown to effectively reduce the burden of ventricular tachycardia in patients with implanted cardioverter-defibrillator (ICD). However, in patients with ICD implantation for secondary prevention of ventricular tachycardia (VT), the appropriate time point of CA and its effect on mortality and heart failure progression remains a matter of debate.METHODS AND ANALYSIS: We present the design of the ongoing preventive aB lation of vE ntriculartachyca R dia in patients with myocardia L IN farction (BERLIN VT) study that aims to prospectively enrol 208 patients with a stable ischaemic cardiomyopathy, a left ventricular ejection fraction of 30% to 50% and documented ventricular tachycardia. Patients will be 1:1 randomised to undergo CA at the time of ICD implantation or CA after the third appropriate ICD shock for ventricular tachycardia. ICD implantation will be performed in all patients. The primary endpoint is defined as the time to first event comprising all-cause mortality and unplanned hospital admission for congestive heart failure or for symptomatic VT/ventricular fibrillation. The patients will be followed until study termination according to the event driven design. Completion of enrolment is expected for mid of 2019.ETHICS AND DISSEMINATION: The study had been approved by the "Ethik-kommission der Landesärztekammer Hamburg" as well as the local institutional review boards for each of the participation sites. The results of the trial will be published in peer-reviewed journals TRIAL REGISTRATION NUMBER: NCT02501005.

U2 - 10.1136/bmjopen-2018-022910

DO - 10.1136/bmjopen-2018-022910

M3 - SCORING: Journal article

C2 - 31072848

VL - 9

SP - e022910

JO - BMJ OPEN

JF - BMJ OPEN

SN - 2044-6055

IS - 5

ER -