Abbott Implants Dual-Chamber Leadless Pacemaker in Clinical Trial
The clinical trial will evaluate the safety and efficacy of Abbott's Aveir DR leadless pacemaker in patients across the US, Canada, and Europe indicated for dual-chamber bradycardia pacing.
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By - Abbott recently announced the world's first implant of a dual-chamber leadless pacemaker system as part of its Aveir DR i2i pivotal clinical trial.
The prospective investigational study will evaluate the clinical safety and efficacy of the Aveir DR leadless pacemaker in 550 patients across 80 sites in the US, Canada, Europe, and Asia-Pacific indicated for dual-chamber bradycardia pacing.
Abbott's i2i technology provides beat-by-beat communication between two leadless pacemakers, one in the right ventricle and one in the right atrium. The technology regulates the heart rate synchronously between chambers and allows for accurate dual-chamber leadless pacing.
Additionally, Aveir DR can beis replaceabled as therapy needs evolve and provides real-time mapping capability so physicians can assess therapy delivery and reposition the device before implantation during a patient's procedure, an Abbott spokesperson explained.
Petr Neuzil, MD, PhD, head of the cardiology department at Na Homolce Hospital in the Czech Republic, and co-investigator, Vivek Y. Reddy, MD, performed the first implant.
"The first-in-human implant of a dual-chamber leadless pacemaker is a major clinical milestone that will open up new possibilities for patients requiring pacing support," Daniel J Cantillon, MD, clinical trial steering committee co-chair, associate section head, and research director of cardiac electrophysiology and pacing at Cleveland Clinic, MD, said in the announcement.
"Abbott has designed a device capable of treating these patients, and we're excited to see this technology advance patient care," Cantillon continued.
Nearly 80 percent of people who receive a pacemaker require a dual-chamber option to pace both chambers on the right side of the heart.
Leadless pacemakers work like traditional pacemakers to regulate heart rate. But historically, leadless pacing options have been limited to single-chamber devices because synchronization of two leadless pacemakers is challenging to achieve.
"As leadless pacing technology has evolved, we've reached this point in time where dual-chamber pacing without leads has become a reality is a monumental moment for modern medicine," said Reinoud Knops, MD, PhD, clinical trial steering committee co-chair and department of cardiology and electrophysiology at the Amsterdam University Medical Center.
