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New treatment option for Mitral Regurgitation
Official title SQ-Kyrin TMVr FIM Study
ClinicalTrials.gov ID: NCT05040074
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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; people who are judged as not...
- Porcelain aorta or active ascending aortic atheroma
- Prior radiation therapy to mediastinum
- History of mediastinitis
You likely can't join 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;
See the full eligibility criteria
- 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; people who are judged as not tolerating mitral valve surgery due to STS procedural mortality risk ≥ 8%...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.