SQ-Kyrin Transcatheter Mitral Valve Repair System Feasibility Study
A feasibility study to evaluate the effectiveness and safety of the SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System for the treatment of moderate-to-severe mitral regurgitation in patients with high surgical risk.
• Severe mitral valve regurgitation ≥ 3+ (moderate-to-severe mitral regurgitation disease);
• Patients with high or prohibitive risk for conventional open thoracic surgery as defined by STS risk scoring result; subjects who are judged as not tolerating mitral valve surgery due to STS procedural mortality risk ≥ 8% for mitral valve replacement or presence of any of the following risk factors:
‣ Porcelain aorta or active ascending aortic atheroma
⁃ Prior radiation therapy to mediastinum
⁃ History of mediastinitis
⁃ Left ventricular ejection fraction (LVEF) \< 40%
⁃ Presence of unobstructed coronary artery bypass graft
⁃ History of 2 or more cardiothoracic surgeries
⁃ Liver cirrhosis
⁃ Other surgical risk factors
• Degenerated MR patients, or functional MR patients who have received guideline-directed medical therapy (GDMT therapy)
• Age ≥ 18 years, male or female;
• Patients who are at extremely high risk or not suitable for conventional mitral valve surgery, as assessed by a multidisciplinary heart team (including at least one cardiac surgeon and one cardiologist);
• Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique and can be treated by the SQ-Kyrin device;
• Patients who can understand the objectives of the trial, volunteer to participate in the study, sign the informed consent form, and are willing to receive related examinations and clinical follow-up.