Rationale and design of BERLIN VT study: a multicenter randomised trial comparing preventive versus deferred ablation of ventricular tachycardia
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Rationale and design of BERLIN VT study: a multicenter randomised trial comparing preventive versus deferred ablation of ventricular tachycardia. / Tilz, Roland Richard; Kuck, Karl-Heinz; Kääb, Stephan; Wegscheider, Karl; Thiem, Annette; Wenzel, Beate; Willems, Stephan; Steven, Daniel.
In: BMJ OPEN, Vol. 9, No. 5, 09.05.2019, p. e022910.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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 -