Abbott has initiated the CROWN-MV pivotal trial evaluating the safety and effectiveness of its investigational Cephea mitral valve system in treating people with symptomatic mitral valve disease who are not candidates for surgery and transcatheter repair.
The first enrolment in the study occurred at Ascension Via Christi Hospital in Wichita (USA) led by Bassem Chehab.
The prospective study will enrol up to 585 people in the USA, Canada and Europe diagnosed with either moderate-to-severe or severe mitral regurgitation (MR) or mitral annular calcification (MAC).
“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,” said Juan F Granada, president and chief executive officer of the Cardiovascular Research Foundation (CRF) and CROWN-MV trial chair. “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.”
The Cephea device is a transcatheter, bioprosthetic valve, designed to complement Abbott’s mitral valve portfolio that includes the MitraClip and Tendyne systems.
The first 30-day early feasibility study outcomes for patients treated with the third-generation Cephea delivery system will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference (31 October–1 November, San Diego, USA).
“With Abbott’s first-of-its-kind MitraClip, we were pioneers in offering a minimally invasive therapy to treat mitral regurgitation. Building on more than two decades of mitral valve leadership, Cephea is one example of how Abbott continues to innovate to address the diverse needs of patients with mitral valve disease,” said Sandra Lesenfants, senior vice president of Abbott’s structural heart business. “Early clinical experience with Cephea and the launch of the CROWN-MV pivotal trial underscore the potential of this technology and move us closer to understanding how it may benefit patients with mitral valve disease.”
