A Clinical Study of X-Clip Mitral Valve Clip System and Steerable Guide System for Transcatheter … (NCT07660185) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Clinical Study of X-Clip Mitral Valve Clip System and Steerable Guide System for Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation
Spain15 participantsStarted 2027-03-01
Plain-language summary
Shenzhen Lifevalve Medical Scientific Co., Ltd. has developed a new X-Clip Mitral Valve Clip System and its compatible Steerable Guide System, aiming to provide transcatheter mitral valve repair for patients with degenerative mitral regurgitation. The two systems have completed all preclinical tests, including design verification tests, biological evaluation, and animal studies. All the test results confirmed that the systems met relevant design requirements. A First-in-Man clinical study was conducted in China in 2023, involving 11 patients. The study provides initial evidence that the X-Clip Mitral Valve Clip System and Steerable Guide System demonstrate favourable safety and efficacy in the treatment of mitral regurgitation in the Chinese population. The device is currently undergoing a pivotal clinical trial in China.
This study is a clinical study aimed to evaluate the safety and performance of the X-Clip Mitral Valve Clip System and Steerable Guide System in European population.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 years of age or older, no gender limit;
. New York Heart Association function class II, III or IV;
. Moderate-to-severe or severe mitral valve regurgitation (grade≥3+) confirmed by transthoracic echocardiography or transesophageal echocardiography;
. Patients with symptoms, or without symptoms but with left ventricular ejection fraction (LVEF) ≤ 60% or left ventricular end-systolic diameter (LVESD) ≥ 40 mm;
. Patients are determined to be at a high risk for mitral valve surgery by cardiologists and should meet at least one of the following four criteria:
. The American Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) is ≥ 6% for valve repair or is ≥ 8% for valve replacement;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of major adverse events (MAEs) within 30 days after operation
Timeframe: At pre-discharge, 30 days ± 7 days post-procedure
2
Clinical success rate
Timeframe: At 12 months ± 30 days post-procedure
Trial details
NCT IDNCT07660185
SponsorShenzhen Lifevalve Medical Scientific Co., Ltd.
. Presence of ≥2 frailty indices (moderate to severe frailty);
. Presence of ≥2 major organ dysfunctions that could not be improved after surgery;
Exclusion criteria
. Patients who are unable to tolerate the treatment, including those with allergies or hypersensitivity to anticoagulant or antiplatelet agents;
. Patients with contraindications to antithrombotic medication, or those with a history of cerebral hemorrhage, gastrointestinal hemorrhage, or hemorrhagic disorders within the past 3 months;
. Patients known to have hypersensitivity or allergic reactions to nickel or titanium, cobalt, chromium, polyester, fluoropolymers, or contrast media;
. Patients with active mitral valve endocarditis, rheumatic mitral valve disease, or mitral valve leaflet abnormalities (i.e. noncompliant, perforation) resulting from endocarditis or rheumatic heart disease;
. Patients with active infections that significantly impact both the outcome of mitral valve transcatheter interventions and postoperative recovery;
. Patients with intracardiac thrombus, vegetations, or masses identified by echocardiography;
. Patients with coronary artery stenosis requiring revascularization, or those who have undergone coronary artery surgery within the past 30 days;
. Patients with aortic stenosis or regurgitation requiring surgical intervention, as well as those with other cardiac conditions necessitating surgical treatment, as judged by clinicians;