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

BMJ Open. 2019 May 9;9(5):e022910. doi: 10.1136/bmjopen-2018-022910.

Abstract

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.

Keywords: catheter ablation; coronary artery disease; implantable cardioverter-defibrillator; myocardial infarction; ventricular tachycardia.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Catheter Ablation / statistics & numerical data*
  • Defibrillators, Implantable*
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Prospective Studies
  • Randomized Controlled Trials as Topic / methods*
  • Stroke Volume / physiology
  • Tachycardia, Ventricular / physiopathology
  • Tachycardia, Ventricular / prevention & control*
  • Tachycardia, Ventricular / therapy
  • Treatment Outcome
  • Ventricular Fibrillation / physiopathology
  • Ventricular Fibrillation / prevention & control*
  • Ventricular Fibrillation / therapy

Associated data

  • ClinicalTrials.gov/NCT02501005