Abbott’s Aveir CSP Leadless Pacemaker Evaluated in Acute Clinical Feasibility Study

April 27, 2025—Abbott announced late-breaking data from the AVEIR conduction system pacing (CSP) acute clinical feasibility study, which demonstrated the safety and performance of the company’s investigational Aveir CSP leadless pacemaker technology.

The AVEIR CSP study is assessing the leadless pacemaker for delivering conduction pacing to the heart’s left bundle branch (LBB) area. The CSP pacing approach targets the LBB area by enabling pacing that mimics the heart’s natural electrical rhythm, noted the company.

The results were presented as a late-breaking clinical trial at Heart Rhythm 2025, the 46th annual meeting of the Heart Rhythm Society held April 24-27, 2025, in San Diego, California. Simultaneously, Vivek Y. Reddy, MD, et al published the findings online in Heart Rhythm Journal.

According to the company, the study demonstrated successful implantation of the Aveir CSP leadless pacemaker deep into the wall separating the left and right chambers of the heart, with many achieving LBB area pacing. All patients in the study received the Aveir VR ventricular leadless pacemaker at the end of the procedure.

Dr. Reddy is Principal Investigator and Director of Cardiac Arrhythmia Services at Mount Sinai Hospital in New York, New York.

“For the first time, we have successfully demonstrated the feasibility of a leadless pacing system to facilitate CSP in the LBB area of the heart, offering a novel approach to pacing therapy,” commented Dr. Reddy in Abbott’s press release. “Leadless pacing has already demonstrated significant benefits to patients. This new groundbreaking approach may enable a more physiologic way of stimulating the heart with Abbott’s Aveir CSP leadless pacemaker system, giving patients more treatment options.”

Additionally, Abbott advised it recently started enrolling the first patients in the ASCEND CSP pivotal clinical trial. This trial will evaluate the safety and effectiveness of the investigational CSP implantable cardioverter-defibrillator lead at 3 months postimplantation. The pivotal trial will enroll up to 414 patients at up to 70 sites worldwide, including in the United States, Canada, Europe, and the Asia-Pacific region, stated the company.