Abbott Launches Clinical Trial for Revolutionary AVEIR Conduction System Pacing Technology

Abbott's New AVEIR™ Data and Clinical Trials

Abbott, a leader in healthcare innovation, has unveiled groundbreaking data from its first-in-human study on the AVEIR Conduction System Pacing (CSP) technology. The late-breaking findings were presented during the Heart Rhythm Society's 46th annual meeting held in San Diego from April 24-27, 2025. This remarkable technology represents a leap forward in cardiac care by enabling pacing in the left bundle branch area of the heart, thus restoring its natural electrical rhythm.

Key Findings from the Study

In this pioneering clinical feasibility study, the AVEIR CSP leadless pacemaker was successfully implanted, demonstrating both safety and performance. Unlike traditional pacing methods, the AVEIR CSP utilizes a unique technique that targets the heart's left bundle branch (LBB) area. The study, which assessed various aspects of the leadless pacemaker technology, yielded promising outcomes, with many participants achieving left bundle branch area pacing (LBBAP). Dr. Vivek Y. Reddy, the principal investigator and director of cardiac arrhythmia services at Mount Sinai Hospital in New York, stated, "For the first time, we have successfully demonstrated the feasibility of a leadless pacing system to facilitate conduction system pacing in the left bundle branch area of the heart."

The results of this study have opened doors for new pacing therapies, offering patients alternatives that were previously unavailable. Compared to traditional pacing systems, leadless technology aims to minimize complications while maximizing precision in heart stimulation.

New Clinical Trials on the Horizon

Following the successful feasibility study, Abbott has initiated enrollment for the ASCEND CSP pivotal clinical trial. This critical study will assess the safety and efficacy of the investigational CSP Implantable Cardioverter-Defibrillator (ICD) lead. Set to involve up to 414 patients across 70 sites globally, including regions in the U.S., Canada, Europe, and Asia-Pacific, the ASCEND trial aims to gather comprehensive data three months post-implantation.

With the introduction of this uniquely crafted lead, Abbott aspires to enhance long-term outcomes for patients requiring ICD therapy by reducing potential complications associated with traditional methods.

Significance of Conduction Pacing Innovations

Abbott's innovation within the realm of conduction system pacing is set to redefine cardiac care. Both the AVEIR CSP leadless pacemaker and the new CSP ICD lead are receiving Breakthrough Device Designation from the FDA. This designation expedites their review process, underscoring their potential to dramatically improve the lives of patients suffering from life-threatening heart conditions. Randel Woodgrift, senior vice president of Abbott’s cardiac rhythm management business, remarked, "Our ongoing innovation in conduction system pacing has the potential to drive meaningful advancements, offering new potential treatment options for people with slow or irregular heart rhythms."

The integration of advanced pacing technologies such as the AVEIR CSP system could significantly enhance the quality of life for a broad range of patients, marking a substantial shift in the management of heart rhythm disorders.

About Abbott

Abbott is dedicated to helping individuals live healthier lives. Their expansive portfolio includes groundbreaking technologies across diagnostics, medical devices, nutrition, and branded generic medications. With a workforce of 114,000 employees, Abbott's mission extends to providing high-quality healthcare across more than 160 countries, underlining their commitment to advancing medical science for the betterment of patient outcomes worldwide.