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 - Funding Information:
This study is supported by BIOTRONIK SE & Co. KG, Berlin, Germany.
Publisher Copyright:
© 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.
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2019/5/1
Y1 - 2019/5/1
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 aBlation of vEntriculartachycaRdia in patients with myocardiaLINfarction (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 aBlation of vEntriculartachycaRdia in patients with myocardiaLINfarction (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.
UR - http://www.scopus.com/inward/record.url?scp=85065729346&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2018-022910
DO - 10.1136/bmjopen-2018-022910
M3 - Journal articles
C2 - 31072848
AN - SCOPUS:85065729346
SN - 2044-6055
VL - 9
JO - BMJ Open
JF - BMJ Open
IS - 5
M1 - e022910
ER -