Abbott Initiates CROWN-MV Pivotal Trial Evaluating Safety And Effectiveness Of Its Investigational Cephea Mitral Valve System For Symptomatic Mitral Valve Disease

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 enrollment in the CROWN-MV study occurred at Ascension Via Christi Hospital in Wichita, Kan., led by Bassem Chehab, M.D.

The prospective study will enroll up to 585 people in the U.S., Canada and Europe diagnosed with either moderate-to-severe or severe mitral regurgitation (MR, or a leaky mitral valve) or mitral valves that are not functioning properly due to a buildup of calcium in the base of the valves (known as mitral annular calcification, or MAC).

Expanding treatment options for mitral valve disease

Mitral valve disease occurs when the heart's mitral valve does not function properly. It comes in two forms: regurgitation, a condition where blood leaks backward through the heart, or stenosis, a narrowing of the valve which restricts blood flow through the heart.

For patients who are not candidates for mitral valve repair or open-heart surgery, the Cephea system offers an alternative minimally invasive way to replace the valve. The Cephea device is delivered by catheter through a vein in the leg, where it is guided across the wall between the chambers of the heart. The bioprosthetic (tissue) valve is implanted and expanded inside the diseased mitral valve to restore normal blood flow. The investigational Cephea system is designed to complement Abbott's mitral valve portfolio that includes MitraClip™, the world's first minimally invasive transcatheter edge-to-edge repair (TEER) therapy (which clips the leaflets of the mitral valve together), and the first-of-its-kind Tendyne™ transcatheter mitral valve replacement (TMVR) system (which delivers a self-expanding valve through a small incision in the chest).

Data support Cephea's third-generation delivery technology

During an Innovation Session at the 38th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation in San Diego (October 31-November 3, 2026), researchers will present the first 30-day early feasibility study outcomes for patients treated with the third-generation Cephea delivery system. The data presented on Sunday, Nov. 1 at 2:57 p.m. PT will further demonstrate the device's performance in reducing MR and improving quality of life.

Other results highlighting Abbott's heart therapies

Data will be presented at TCT 2026 on a number of Abbott's cardiovascular devices, including:

Late-breaking one-year outcomes from the VERITAS Study of the Amulet 360™ Left Atrial Appendage Occluder (Sunday, Nov. 1, 3:09 p.m. PT)
Thirty-day results from the TECTONIC Coronary Artery Disease (CAD) Intravascular Lithotripsy (IVL) trial of the SonicForce™ Coronary IVL System (Sunday, Nov. 1, 12:44 p.m. PT)
The first report of six-month clinical outcomes from the early feasibility study for the investigational Encantor™ transcatheter aortic valve implantation (TAVI) balloon-expandable system (Sunday, Nov. 1, 11:13 a.m. PT)
Thirty-day results from the PARADIGM trial that supported the recent FDA approval for the Amplatzer™ Paraclose PVL Occluder (Saturday, Oct. 31, 9 a.m. PT)
Five-year outcomes from the IDE study for the Navitor™ TAVI system (Monday, Nov. 2, 3:30 p.m. PT)