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