BIO Continue

BIO|CONTINUE

BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication

Study Design

  • Prospective, international, multicenter study
  • Assesses the relevance of a defibrillator back-up after the replacement of the first CRT-D
  • 277 patients planned – ongoing study
Study Objective
  • BIO|CONTINUE is a study designed to describe, in a population of patients who had a primary prevention ICD indication at first implantation of a CRT-D, the relevance of a defibrillator back-up after the replacement of the first CRT-D
1° Endpoints
  • Assess the rate of patients with at least one sustained ventricular tachyarrhythmia (VTA) after replacement
2° Endpoints
  • Rate of patients with at least one VTA for 4 specific subgroups: Group R (1-4): LVEF ≥40% / <40% at the time of replacement and with / without previous VTA during the lifetime of their first CRT-D device
  • Rate of patients with appropriate therapies
  • Rate of patients with inappropriate therapies
Clinical Sites
  • 40 sites in Belgium, France, Germany, Hungary, Israel, Italy, Portugal, Spain
Sample Size
  • 277 patients planned – ongoing study
Inclusion Criteria
  • Patient with primary prevention indication for defibrillation at the time of the first CRT-D implantation
  • Patient implanted as first replacement by a CRT-D device (CRT-D by CRT-D)
  • Lifetime of the previous CRT-D > 3 years
  • Patient willing and able to comply with the protocol and who has provided written informed consent
  • Patient whose medical situation is stable
Main Exclusion Criteria
  • Patient with an ICD lead under advisory (e.g. Fidelis lead)
  • Right or left ventricular leads exchange during CRT-D replacement
  • Non functional atrial or right/left ventricular leads
  • Life expectancy < 1 year
  • Age < 18 years
  • Pregnant woman or woman who plan to become pregnant during the trial
  • Participation in another interventional clinical study
Devices
  • BIOTRONIK CRT-Ds
Follow-Up
  • Between 2 and 4 years
Study Duration
  • June 2015 - ongoing
Reference No.
  • NCT02323503
Principal Investigator
  • Daniel DG Gras, MD, Nouvelles Cliniques Nantaises, France