Abbott Aveir DR i2i Dual-Chamber Leadless Pacemaker Evaluated in Global Pivotal Clinical Study

February 7, 2022—Abbott announced the first patient implantations of the company’s Aveir dual-chamber leadless pacemaker system as part of the AVEIR DR i2i pivotal clinical study.

The first implantation was performed at Na Homolce Hospital in Prague, Czech Republic, and led by site Principal Investigator Petr Neuzil, MD, Head of the Department of Cardiology, and assisted by site Co-Investigator, Vivek Y. Reddy, MD.

AVEIR DR i2i is a prospective, multicenter, international, single-arm, pivotal investigational study. It is designed to evaluate the clinical safety and efficacy of the Aveir DR leadless pacemaker in patients who were indicated for a DDD(R)—or dual-chamber bradycardia pacing—pacemaker, which stimulates the appropriate chamber of the heart when clinically necessary. The study is planned to enroll up to 550 patients from up to 80 sites in the United States, Canada, Europe, and Asia-Pacific. All patients will be followed for a minimum of 12 months postimplantation.

The study is being led by Daniel J. Cantillon, MD, and Reinoud Knops, MD, the clinical trial steering committee cochairs. Dr. Cantillon is Associate Section Head and Research Director of Cardiac Electrophysiology and Pacing at the Cleveland Clinic in Cleveland, Ohio. Dr. Knops is with the Department of Cardiology and Electrophysiology at Amsterdam University Medical Center in Amsterdam, the Netherlands.

The company noted that historically, leadless pacing options have been limited to single-chamber devices because synchronization of two leadless pacemakers has been highly difficult to achieve. Abbott stated that the company’s i2i (implant-to-implant) technology solves this problem by providing beat-by-beat communication between two leadless pacemakers: one positioned in the right ventricle, and one positioned in the right atrium. This technology is designed to regulate the heart rate synchronously between chambers and allow for true dual-chamber leadless pacing.

“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,” commented Dr. Cantillon in the company’s press release. “Abbott has designed a device capable of treating these patients, and we’re excited to see this technology advance patient care.”

Dr. Knops added, “As leadless pacing technology has evolved, we’ve always viewed dual-chamber leadless technology as a therapy evolution that would have a dramatic impact on more patients—but a technology that was going to be very challenging to develop. That we’ve reached this point in time where dual-chamber pacing without leads has become a reality is a monumental moment for modern medicine.”

The company stated that the Aveir DR leadless pacemaker is designed to be retrievable, so the system can be replaced or retrieved as therapy needs evolve. Also, the Aveir DR system is designed to provide real-time mapping capability so physicians can assess therapy delivery and reposition the device before implant during a patient’s procedure. The device design specifications are subject to change, noted the company.

The Aveir DR i2i leadless pacemaker is an investigational device being clinically evaluated as part of a global pivotal study and is not yet commercially available, advised Abbott.