Biotronik launches new study assessing defibrillator backups

Biotronik has launched BioCONTINUE, a study that will evaluate the relevance of defibrillator backups following the replacement of a cardiac resynchronisation therapy defibrillator (CRT-D).

This will be the first study to investigate the relevance of defibrillator backup following first device replacement in a heart failure patient population with a primary indication for a CRT-D.

A total of 277 patients will be enrolled in 40 centres in eight countries worldwide, with the first having already been signed up. All patients will be implanted with Biotronik's CRT-Ds, with a minimum follow-up period of two years.

The primary endpoint will pertain to the number of patients with at least one sustained ventricular tachyarrhythmia (VTA) or ventricular fibrillation, with the association between baseline characteristics of the CRT-D population after replacement and the risk of subsequent VTAs to be explored in a subgroup analysis.

Albert Panzeri, vice-president at Biotronik, said: "“By observing this specific population, BioCONTINUE will provide key insights into the relevance of defibrillator backup, especially for patients with improved left ventricular ejection fraction and an event-free first CRT-D service life."

This comes after the firm launched BIOWOMEN last month, a study that will evaluate whether women respond better to cardiac resynchronisation therapy than men.