Biotronik launches trial of CLS AF algorithm

Biotronik said today it enrolled the 1st patient in its B3 trial examining the company’s Closed Loop Stimulation physiologic rate response sensor and algorithm.

The study aims to whether pacemakers and implantable cardioverter-defibrillators equipped with the CLS sensor and algorithm are able to reduce the rate of stroke and improve outcomes in patients with atrial fibrillation compared to those without the system.

“AF is a huge clinical challenge, affecting over 20 million patients in Europe and the US alone. I am very excited to begin this groundbreaking trial. We hope to demonstrate that the physiological heart rate modulation induced by CLS in sick sinus disease patients can control clinically relevant AF episodes. CLS may well improve clinical outcomes and lower the incidence of stroke in this particularly challenging patient population,” international study coordinator Dr. Valeria Calvi of Italy’s Ferrarotto Hospital said in a press release.

The 52-center B3 trial is slated to examine 1,308 ICD and pacemaker patients who require dual-chamber pacing due to sinus node disorder. Patients will receive ICDs and pacers that are equipped with CLS, with the setting turned off in half the patients in order to examine the difference the algorithm makes.

The primary endpoint for the trial will be time to 1st onset of new clinically relevant atrial fibrillation episodes or thromboembolic events, with a follow-up at 3 years. A secondary endpoint will examine whether Biotronik home monitoring further reduces risk of stroke and persistent atrial fibrillation, the company said.

“Two previous studies have already demonstrated a significantly lower atrial burden for patients with CLS pacemakers.2,3 We are eager to learn how CLS might reduce the risk of clinically relevant AF and stroke, and improve patients´ quality of life. This trial reaffirms our commitment to supporting our devices and therapies with the highest level of clinical evidence via randomized, controlled trials,” Biotronik center for clinical research director Klaus Contzen said in prepared remarks.

In July, Biotronik said it won FDA premarket approval for its quadripolar Itrevia HF-T cardiac resynchronization defibrillator with CLS and launched the device in the U.S. market.

The Itrevia is approved for use with IS4 compatible left ventricular leads, the German medical device giant said. The 1st patients have already been implanted with the device, the company added.

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