Biotronik commences new BIOSync CLS clinical trial

Biotronik has announced the commencement of BIOSync CLS, a randomised controlled clinical trial assessing the efficacy of its pacemaker technology.

The first patient enrolments have been completed for the new study, which will evaluate the efficacy of pacemakers with closed-loop stimulation (CLS) technology in preventing recurrent syncope, the condition commonly known as fainting.

Syncope is often preceded by either a rapid drop in blood pressure or heart rate, so patients suffering from recurrent fainting are often indicated for a pacemaker to regulate their condition.

Patients in each study arm will receive a Biotronik dual-chamber pacemaker with CLS turned either on or off, in order to compare the time to first recurrence of syncope between the two groups.

Albert Panzeri, vice-president at Biotronik, said: "With the BIOSync CLS trial, we are doing our part to gather clinical evidence with the potential to make a huge difference in these patients' lives."

This comes after the firm commenced a study to evaluate the benefits of a unique rate response algorithm for atrial fibrillation patients earlier this month.