The company’s prospective, multicenter, international, single-arm, pivotal investigational Aveir DR i2i study will evaluate the clinical safety and efficacy of the Aveir DR leadless pacemaker in patients indicated for a DDD(R) or dual-chamber bradycardia pacing pacemaker.
Abbott expects the Aveir DR i2i study to enroll up to 550 patients at up to 80 sites in the U.S., Canada, Europe and Asia-Pacific. All patients will be followed for a minimum of 12 months post-implant. The Aveir DR leadless pacemaker is currently an investigational device.
The Abbott Park, Illinois–based company designed its i2i technology to provide beat-by-beat communication between two leadless pacemakers, with one positioned on the right ventricle and the other in the right atrium. The company aims to synchronize the heart rate between chambers and allow for true dual-chamber leadless pacing.
In contrast, competitor Medtronic’s Micra AV is a single leadless pacemaker with several internal atrial sensing algorithms that detect cardiac movement. The Micra AV can adjust pacing in the ventricle to coordinate with the atrium, enabling it to provide “AV synchronous” pacing therapy to people with atrioventricular block. People with AV block have previously needed a dual-chamber pacemaker, even though only one of the two leads in the system provided heart stimulation.
The design of Abbott’s Aveir DR also includes retrievability as therapy needs evolve. It can also provide real-time mapping for physicians to assess therapy delivery and reposition the device before implant during a patient’s procedure, according to a news release.
Principal investigator Dr. Petr Neuzil — head of the Department of Cardiology at the Na Homolce Hospital in Prague, Czech Republic, performed the first implant. Dr. Vivek Y. Reddy, site co-investigator, assisted with the implantation. Dr. Daniel J. Cantillon (Cleveland Clinic) and Dr. Reinoud Knops (Amsterdam University Medical Center, The Netherlands) are co-chairing the study.
“The Aveir DR dual-chamber leadless pacemaker builds upon our Aveir VR single-chamber leadless platform, and we believe that once approved these systems have the potential to change the way doctors approach the treatment of abnormal heart rhythms,” SVP of Abbott’s Cardiac Rhythm Management Business Randel Woodgrift said in the release. “The involvement of world-class heart institutions in this study reinforces that the innovations we are developing are exactly the kind of advancements physicians around the world want for their patients.”