Mitral Regurgitation (MR)
Conditions
Keywords
MitraFix, Transcatheter Mitral Valve Replacement
Brief summary
The goal of this early feasibility clinical trial is to test a new device called the MitraFix® Transcatheter Mitral Valve System. It aims to learn if the device is safe and if it can help adults who have a severe leaky heart valve (mitral regurgitation). This study is for people who are at high risk for traditional open-heart surgery. The main questions it aims to answer are: Is the MitraFix system safe for participants? Can the device be successfully placed in the heart? Does the device help reduce the valve leak and improve daily life? Participants will: Receive the MitraFix valve through a small tube inserted into a vein in the leg. Visit the clinic for heart tests, walking tests, and health checks for up to one year after the procedure.
Interventions
DEVICEMitraFix® Transcatheter Mitral Valve System
The MitraFix® Transcatheter Mitral Valve System is implanted via a transfemoral-transseptal approach.
Sponsors
Mitrassist Lifesciences Limited Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate to severe or severe (≥3+) mitral regurgitation. * Age ≥ 18 years. * Patients at high risk for traditional open-heart surgery, defined as: STS mortality risk for mitral valve replacement ≥ 8%; OR presence of 2 or more frailty indices; OR presence of 2 or more major organ dysfunctions that cannot be improved post-operatively; OR other comorbidities or factors making them unsuitable for surgery. * Anatomically suitable for transcatheter MitraFix® system implantation via a transfemoral-transseptal approach as assessed by the investigator; the transfemoral-transseptal access route meets the requirements of the delivery system. * Able to understand the study purpose, voluntarily participate, sign the informed consent form, and willing to accept relevant examinations and clinical follow-ups.
Exclusion criteria
* Severe mitral stenosis. * Severe calcification of mitral leaflets and/or annulus; anatomical structures of the mitral valve apparatus (e.g., papillary muscles) unsuitable for device implantation. * High risk of left ventricular outflow tract obstruction (LVOTO) based on pre-operative CT/TEE planning (estimated neo-LVOT \< 150 mm²), which cannot be avoided by procedural optimization. * Presence of previous implants in the mitral position (surgical bioprosthetic or mechanical valves, surgical annuloplasty rings, etc.). * Infective endocarditis or evidence of active infection. * Stroke or transient ischemic attack (TIA) within 90 days. * Severe untreated coronary artery disease or acute myocardial infarction within 90 days; or percutaneous coronary intervention (PCI)/coronary stent implantation within 90 days. * Severe pulmonary hypertension (resting PASP \> 70 mmHg, assessed as irreversible). * Severe right ventricular dysfunction: Tricuspid Annular Plane Systolic Excursion (TAPSE) \< 17 mm. * Concomitant tricuspid valve, aortic valve, or severe great vessel disease requiring surgical or interventional treatment. * Left ventricular ejection fraction (LVEF) \< 30%. * Extreme frailty preventing tolerance of the procedure, or in a state of shock requiring circulatory support. * Implantation of CRT, CRT-D, or implantable cardioverter-defibrillator (ICD) within 30 days. * Chronic dialysis or expected need for long-term dialysis; or severe renal impairment (e.g., eGFR \< 30 mL/min/1.73m²) unable to undergo perioperative dialysis. * Documented coagulopathy or severe hematological disorders (e.g., platelet count \< 50×10\^9/L, active bleeding), or history of heparin-induced thrombocytopenia (HIT). * Contraindications to anticoagulant/antiplatelet therapy that cannot be substituted or bridged. * Echocardiographic evidence of any intracardiac mass, or thrombus in the left ventricle or left atrium (including left atrial appendage). * Contraindications to transesophageal echocardiography (TEE). * Severe allergy to iodine contrast media, nitinol, bovine-derived materials, or other device materials that remains intolerable despite premedication. * Life expectancy \< 12 months. * Pregnant or breastfeeding women. * Unsuitable for the transfemoral-transseptal approach (e.g., femoral vein diameter, calcification, tortuosity, or atrial septum/left atrial anatomy not meeting delivery system requirements). * Participation in another clinical study of an investigational device or drug within 3 months prior to screening that may interfere with this study. * Any other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Success Rate | 30 days post-procedure | evice success is defined as the patient being alive and free from stroke, with the implanted valve in the intended position and functioning properly, without the need for re-operation or re-intervention due to device-related complications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success Rate | Intra-operative (At the time of procedure) | Percentage of participants achieving technical success, defined as successful access, delivery, and deployment of the device, and successful retrieval of the delivery system. |
| Procedural Success Rate | 30 days post-procedure | Percentage of participants achieving procedural success, typically defined as technical success without the occurrence of major device- or procedure-related serious adverse events. |
| Valve Performance Assessment | Up to 12 months post-procedure | Evaluated by echocardiography, including the severity of residual mitral regurgitation, transvalvular pressure gradient, and the presence/severity of paravalvular leak. |
| Change in New York Heart Association (NYHA) Functional Class | Up to 12 months post-procedure | Assessment of clinical improvement in heart failure symptoms based on the NYHA classification (Class I to IV, where a lower class indicates better function). |
| Change in Quality of Life Assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | Up to 12 months post-procedure | Quality of life is evaluated using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ Overall Summary Score ranges from 0 to 100. Higher scores indicate fewer symptoms and better health-related quality of life. |
| Change in 6-Minute Walk Distance | Up to 12 months post-procedure | The change in the total distance (in meters) a participant can walk on a flat surface in 6 minutes, used to evaluate exercise capacity. |
| Rate of Hospitalization for Heart Failure | Up to 12 months post-procedure | Number of participants requiring hospital admission or an emergency/urgent care visit for the treatment of worsening heart failure. |
| Incidence of Major Adverse Events (MAEs) | Up to 12 months post-procedure | Number of participants experiencing major adverse events, such as all-cause mortality, stroke, life-threatening bleeding, or acute kidney injury. |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 12 months post-procedure | Number of participants experiencing any device-related or procedure-related adverse events and serious adverse events. |
Countries
China
Contacts
CONTACTNaXin Di
Outcome results
None listed