Biotronik said today it enrolled the 1st patients in its BioSync CLS trial looking to examine whether its closed loop stimulation-equipped pacemakers can prevent syncope.
Recurrent syncope, or fainting, is often proceeded by a drop in blood pressure or heart rate, so patients diagnosed with the disorder are often indicated for pacemakers, Biotronik said.
“While not fatal, recurrent syncope is quite dangerous and seriously compromises the patient’s quality of life. Previous studies have provided contradictory results regarding the benefit of cardiac pacing in syncope, and the current European Society of Cardiology guidelines for this indication suggest that further study is necessary. The BioSync CLS trial has the potential to clarify whether a dual-chamber pacemaker with the uniquely physiologic CLS pacing algorithm is able to detect and quickly neutralize syncope. I am very excited to begin this highly significant trial,” international study coordinator Dr. Michele Brignole said in a prepared statement.
The double-blinded, multicenter trial is slated to include 30 study centers in Europe and Canada and enroll 128 patients with a pacemaker indication for treating recurrent syncope. Patients will receive a Biotronik dual-chamber pacemaker with CLS either on or off, depending on their group.
The trial’s primary endpoint will compare time to 1st-recurrence of syncope between the groups, and the study will have a follow-up period of 2 years.
“A number of previous trials have shown that CLS is sensitive to contractility, or the self-contraction of the heart muscle.1,2,3 We hypothesize that pacemakers with CLS are uniquely capable of detecting the increase in contractility which can occur in the early stage of a syncopal event. They should therefore be able to initiate cardiac pacing at an earlier stage to prevent the sudden drop in heart rate which often causes syncope. If our hypothesis is proven correct, implications for treatment indications and guidelines would be widespread,” 1st implanter Dr. Marco Tomaino of Italy’s Bolzano Hospital said in prepared remarks.
Biotronik’s CLS system determines appropriate heart rate based on intracardiac impedance measurements, which provides “optimal heart rates under varied circumstances,” the company said.
“At Biotronik patient safety and quality of life is central to everything we do. Syncope patients are a quite challenging patient population, with no other treatment options currently available and a lack of clear consensus among the medical community. 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,” veep Albert Panzeri said in a press release.
Earlier this month, Biotronik said it enrolled the 1st patient in its B3 trial examining the company’s Closed Loop Stimulation physiologic rate response sensor and algorithm for reducing stroke in patients with atrial fibrillation.
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 AF compared to those without the system.