Mitral regurgitation
Conditions
Sponsors
Department of Cardiology, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: (1) Moderate or severe mitral regurgitation =3+ (including DMR and FMR, not excluding stenosis); (2)FMR patients must have received standard medical treatment (GDMT) for at least 30 days; (3)DMR patients were enrolled if they were assessed by the heart team as having high surgical risk or could not tolerate surgery; (4) male patients aged =18 years or non-pregnant or non-lactating women; (5) predicted survival time > 12 months; (6) left ventricular ejection fraction =20%; (7) effective mitral orifice area =4.0cm2; (8) NYHA class =?; (9) anatomically suitable for transcatheter mitral valve repair and suitable for the study device as assessed by the physician; (10) patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent, and are willing to undergo relevant examinations and clinical follow-up.
Exclusion criteria
Exclusion criteria: (1) previous history of mitral valve surgery; (2) patients with infective endocarditis or suggestive of active infection; (3) complicated with severe coronary artery disease without effective treatment; (4) patients with pulmonary hypertension (pulmonary artery systolic pressure > 70mmHg); (5) patients with severe right ventricular dysfunction; (6) the patient was too weak to tolerate general anesthesia or was in shock and needed circulatory support; (7) patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis; (8) patients undergoing chronic dialysis; (9) patients with definite coagulation dysfunction and severe coagulation system diseases; (10) patients with contraindications to anticoagulant drugs; (11) patients with stroke or transient ischemic attack within 30 days; (12) Any intracardiac mass, left ventricular or atrial thrombus detected by echocardiography; (13) patients with other valvular diseases requiring surgery or interventional therapy; (14) patients with severe macrovascular disease requiring surgical treatment; (15) patients with inappropriate heart and valve anatomy according to imaging examination; (16) known to be allergic to contrast media and nickel-titanium memory alloy products; (17) patients with severe neurological disorders affecting cognitive ability; (18) patients with severe thoracic deformity; (19) patients with severe chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or long-term oral corticosteroid therapy; (20) The investigator judged that the patient had poor compliance and could not complete the study as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the effectivity of the product at 30 days after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate immediately after operation;The device success rate immediately after operation and 30 days after operation;The success rate of surgery immediately after surgery and 30 days after surgery;Incidence of serious adverse events at 30 days, 6 months, and 12 months after surgery;The effective rate of the product was 6 months and 12 months after operation;All-cause mortality at 30 days, 6 months and 12 months after surgery; | — |
Countries
China
Contacts
Public ContactChen Mao
West China Hospital, Sichuan University
Outcome results
None listed