Abbott announced October 29 that it has started CROWN-MV, a pivotal clinical trial of its investigational Cephea Mitral Valve System.
The study will evaluate safety and effectiveness in people with symptomatic mitral valve disease who are not candidates for surgery and transcatheter repair. Abbott said enrollment began at Ascension Via Christi Hospital in Wichita, Kansas, led by Bassem Chehab.
The prospective, global study plans to enroll up to 585 people across the United States, Canada and Europe. Its population includes patients with severe mitral regurgitation and those with valve dysfunction associated with mitral annular calcification.
Cephea remains investigational in the United States. The trial’s initiation is a research milestone, rather than a finding that the device is safe or effective.
Abbott also scheduled a separate presentation of 30-day early-feasibility results involving the device’s third-generation delivery system for November 1 at the Transcatheter Cardiovascular Therapeutics meeting in San Diego. Those results had not yet been presented when the company issued Thursday’s announcement.
Sources: Abbott — October 29 Trial Announcement: https://www.prnewswire.com/news-releases/abbott-initiates-pivotal-trial-for-cephea-device-an-innovative-treatment-for-mitral-heart-valve-disease-302921856.html