Yunnan Fuwai Cardiovascular Hospital Completes First-in-Nation Enrollment in MitraFix™ Transcatheter Mitral Valve Replacement Pivotal Trial

Recently, Executive President Pan Xiangbin of Yunnan Fuwai Cardiovascular Hospital, along with Directors Pan Jiahua, Hu Xiaopeng, Zhu Da, Wang Shouzheng, and Luo Zhiling, Director of the Echocardiography Department, successfully completed the first registration clinical trial of MitraFix™, China's first independently developed interventional mitral valve replacement product, developed by MitrAssist Lifesciences. Conducted in close collaboration with a multidisciplinary Heart Team, this milestone marks the official launch of the NMPA registration trial with Academician Hu Shengshou serving as the national Principal Investigator (PI), ushering in a new chapter in China's interventional mitral valve therapy field.

The patient is a male aged over 60 years, admitted due to recurrent fatigue and dyspnea, accompanied by progressive bilateral lower extremity edema. Admission diagnosis: severe mitral regurgitation, NYHA Class III cardiac function, complicated by atrial fibrillation, hypothyroidism, severe chronic obstructive pulmonary disease, and other complications. Echocardiography revealed: left atrial enlargement, left ventricular enlargement, reduced cardiac function, pulmonary hypertension, mitral annular dilatation, prolapse of both anterior and posterior leaflets, and mixed mitral valve disease (FMR combined with DMR).

Following comprehensive multidisciplinary team (MDT) discussion and evaluation of the patient’s condition at Yunnan Fuwai Hospital, the patient was identified as a high-risk candidate for conventional surgery. Given that the anatomical features of the valvular lesion precluded transcatheter repair, the decision was made to proceed with transapical mitral valve implantation using the MitraFix™ system. Preoperative cardiac CTA revealed a D-shaped mitral annulus with an area-derived equivalent diameter of 34 mm. Simulation of implanting a size 34 transcatheter mitral valve (outer diameter approximately 40 mm) predicted that the left ventricular neo-LVOT area would remain >150 mm². The procedure was performed under echocardiographic guidance alone. A transapical approach was utilized via a 4-cm minimally invasive left intercostal incision. Under ultrasound guidance, the delivery system accurately crossed the native valve, and the prosthetic valve was precisely deployed at the mitral annulus. Following deployment, the valve frame demonstrated secure apposition with no paravalvular leak or intravalvular regurgitation. Antegrade flow across the mitral valve was unobstructed, with a mean pressure gradient of 2 mmHg. The left ventricular outflow tract remained patent, with an outflow tract blood flow velocity of 2.3 m/s and a mean pressure gradient of 8 mmHg. The delivery system was smoothly withdrawn, the apical incision was closed, and the procedure concluded successfully.

(Intraoperative TEE revealed left heart enlargement, extensive systolic leaflet prolapse, and reduced cardiac function.)

(Utilizing 3D for multi-planar positioning to guide valve deployment)

Mitral valve disease is the valvular heart condition with the highest incidence and poses the greatest challenges for interventional therapy. In China, according to incomplete statistics, the number of potential patients with mitral valve disease exceeds 10 million, highlighting a substantial treatment gap. Meanwhile, the complex disease spectrum of mitral regurgitation, encompassing degenerative (DMR) and functional (FMR) mitral regurgitation, significantly increases the therapeutic difficulty for such valvular pathologies. Consequently, the research and development of interventional devices for mitral valve diagnosis and treatment has become both a focal point and a major challenge in the global cardiovascular interventional field. Unlike interventional mitral valve repair, interventional replacement is not constrained by the anatomical variations of the diseased valve, offering superior anatomical adaptability for patients and broader clinical application prospects, thereby emerging as a key R&D focus internationally. As China's first interventional mitral valve replacement product with globally independent intellectual property rights and dual delivery approaches (transapical and transfemoral venous), the successful advancement of the NMPA registration clinical trial for the MitraFix™ interventional prosthetic mitral valve marks a significant new milestone in China's interventional mitral valve diagnostics and therapeutics.

Under the guidance of Academician Hu Shengshou and the leadership of Professor Pan Xiangbin, the Structural Heart Disease Team of Fuwai Hospital, Chinese Academy of Medical Sciences, and Yunnan Fuwai Cardiovascular Hospital has continuously advanced the field of transcatheter mitral valve interventions. To date, the team has cumulatively completed nearly 100 transcatheter mitral valve procedures, covering multiple technical pathways including transcatheter mitral valve replacement, transcatheter mitral valve edge-to-edge repair, and transcatheter artificial chordae tendineae repair, thereby establishing a comprehensive treatment system. The team has innovatively introduced the technical concept of fully ultrasound-guided transcatheter mitral valve diagnosis and intervention. Related series of academic achievements have been published in top-tier journals such as JACC: Cardiovascular Interventions. We look forward to more Chinese-produced original devices and technologies benefiting a broad population of patients with valvular heart disease in China.