Biotronik begins clinical trial to assess new atrial fibrillation intervention

Biotronik has commenced a new trial assessing the potential clinical benefit of a new treatment for atrial fibrillation.

The first patients have been enrolled in the B3 study, which will evaluate the effectiveness of the physiologic rate response sensor Closed Loop Stimulation (CLS) in atrial fibrillation patients.

Specifically, it will assess whether pacemakers and implantable cardioverter-defibrillators equipped with CLS can reduce the rate of stroke and improve patient outcomes, with 1,308 patients to be enrolled across 52 study centres.

Patients in each study arm are to receive a Biotronik pacemaker or implantable cardioverter-defibrillator with CLS turned on or off. The primary endpoint is the time to initial onset of new clinically relevant atrial fibrillation episodes or thromboembolic events, with a follow-up period of three years. 

Klaus Contzen, director for the centre for clinical research at Biotronik, said: "This trial reaffirms our commitment to supporting our devices and therapies with the highest level of clinical evidence via randomised controlled trials."

This comes after the firm recently announced the European launch of BioMonitor 2, its new continuous and reliable arrhythmia monitoring system.