SQ-Kyrin TMVr FIM Study

Recruiting now · Not applicable

Conditions studied: Mitral Regurgitation

In brief

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.

Key facts

Study ID

NCT05040074

Run by

Shanghai Shenqi Medical Technology Co., Ltd

People needed

20

Starts

2021-04-01

Expected to finish

2026-10-01

Last updated by the study team

2021-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• History of cardiac and mitral valve surgeries;
• Infective endocarditis or evidence of active infection;
• Mitral valve stenosis;
• Severe uncontrolled coronary artery disease;
• Pulmonary artery hypertension (systolic pulmonary artery pressure > 70 mmHg);
• Severe right cardiac insufficiency;
• LVEF < 30%;
• Cardiac function of NYHA Class IV;
• Patient is extremely week to tolerate surgery under general anesthesia, or in a shock state indicating circulatory support;
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis;
• Chronic dialysis;
• Definite coagulation disorder and severe coagulation system diseases;
• Clear contraindications for use of anticoagulants;
• Cerebral stroke or transient ischemic attack in the past 30 days;
• Any cardiac mass, left ventricular or atrial thrombosis identified by echocardiography;
• Other valve diseases that requiring surgery or intervention;
• Severe macrovascular disease requiring surgical treatment;
• Treatment-naive carotid artery stenosis > 70%;
• Imaging evidence of inappropriate cardiac and valve anatomy;
• Known hypersensitivity to contrast media, and nickel-titanium memory alloy products;
• Severe nervous system disorder compromising the cognitive ability;
• Life expectancy < 12 months;
• Severe thorax deformity;
• Pregnant and lactating women.

Where it is running

• General Hospital of Northern Theater Command, PLA — Shenyang, Liaoning, China (enrolling)

Full record on ClinicalTrials.gov

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