CROWN-MV Pivotal Trial Begins for Abbott’s Cephea Device for Mitral Valve Disease

October 29, 2026—Abbott announced it has initiated the CROWN-MV pivotal trial evaluating the safety and effectiveness of the company’s investigational Cephea mitral valve system in treating patients with symptomatic mitral valve disease who are not candidates for surgery and transcatheter repair.

According to Abbott, the prospective study will be composed of patients diagnosed with either moderate-to-severe or severe mitral regurgitation or mitral valve dysfunction associated with mitral annular calcification. The study will enroll up to 585 patients in the United States, Canada, and Europe. The first enrollment in the CROWN-MV study was led by Bassem Chehab, MD, at Ascension Via Christi Hospital in Wichita, Kansas.

Juan F. Granada, MD, who is President and Chief Executive Officer of the Cardiovascular Research Foundation, serves as the CROWN-MV trial chair.

“Patients with severe symptomatic mitral valve disease often cannot undergo conventional surgery or transcatheter mitral valve repair, and therapeutic options for these patients have been extremely limited,” commented Dr. Granada in the Abbott press release. “The initiation of the CROWN-MV trial represents an important step forward in bringing a dedicated single-step catheter-based replacement option to clinical practice for these high-risk patients. Designed to treat complex mitral anatomies, Cephea has the potential to address a significant unmet patient need.”

Abbott advised that the first 30-day early feasibility study outcomes for patients treated with the third-generation Cephea delivery system will be presented during an Innovation Session at TCT 2026. The data will demonstrate the device’s performance in reducing mitral regurgitation and improving quality of life, noted the press release.