A Clinical Study of X-Clip Mitral Valve Clip System and Steerable Guide System for Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation
A Pre-Market, Prospective, Single-Arm, Open-Label Clinical Study of X-Clip Mitral Valve Clip System and Steerable Guide System for Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation
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.
연구 개요
상태
상세 설명
Mitral regurgitation (MR) is the most prevalent valvular heart disease globally. It is characterized by the backward flow of blood from the left ventricle (LV) into the left atrium (LA) through the mitral valve during systole, usually due to improper closure of the valve leaflets. This hemodynamic impairment can ultimately result in symptoms of heart failure, including fatigue, dyspnea, and progressive left ventricular dysfunction. MR affects 2-3% of the general population, with a prevalence increasing with age. Nearly 1 in 10 individuals aged ≥ 75 years reportedly has moderate or severe MR. This condition is associated with significant morbidity and mortality, making accurate diagnosis and management critical. In Europe, MR represents the second most prevalent valvular disorder requiring cardiac surgical intervention, highlighting its clinical significance in contemporary cardiology practice.
MR is classified based on its underlying etiology and mechanism. Primary mitral regurgitation (PMR), or degenerative mitral regurgitation (DMR), results from intrinsic abnormalities of the mitral valve apparatus, such as degenerative changes in the valve leaflets, myxomatous infiltration, calcification of the annulus, or damage to the chordae tendineae. Secondary mitral regurgitation (SMR), or functional mitral regurgitation (FMR), typically occurs due to heart failure, left ventricular dilation, and altered coaptation of the mitral annulus. It arises when the mitral valve anatomy is normal, but abnormalities of the left ventricle or the left atrium disrupts the normal valvular function.
Surgical mitral valve intervention remains the gold standard for many patients, particularly those with severe and symptomatic DMR. However, nearly 50% of the patients with MR cannot undergo surgery due to comorbidities, advance age or high surgical risk. For these patients, transcatheter therapies offer a viable alternative, focusing on leaflet or annulus repair, or valve replacement. The most widely used technique is leaflet approximation (mitral transcatheter edge-to-edge repair, M-TEER) with more than 150,000 implantations worldwide. The TEER technique is minimally invasive with low risks. Compared to surgical repair, TEER results in fewer complications and shorter hospital stays.
Several TEER devices are available for MR treatment. Among them, the MitraClip device by Abbott Laboratories is the most widely adopted TEER device globally, while the PASCAL system by Edwards Lifesciences provides an alternative technology that may offer specific advantages in certain clinical scenarios. The X-ClipTM Mitral Valve Clip System and Steerable Guide System shares a similar concept with MitraClip and PASCAL systems but has unique features. It features a larger clamping area and employs a mechanical elastic clip design to ensure precise capture and grasping of leaflets. The system was initially studied in the First-in-Man feasibility study in China, which showed that TEER using the system is feasible and safe for the treating patients with moderate-to-severe and severe mitral regurgitation.
Here, this clinical study aims to further evaluate the safety and performance of the X-ClipTM Mitral Valve Clip System and Steerable Guide System in European population with moderate-to-severe and severe degenerative mitral regurgitation who are at high surgical risk and have suitable mitral anatomy for TEER.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Kadir Shemsi, CTM
- 전화번호: 0852-91426007
- 이메일: kadirr@lifetechmed.com
연구 연락처 백업
- 이름: Nora Wu, APM
- 이메일: wuyuying@lifetechmed.com
연구 장소
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Barcelona, 스페인, 08036
- Hospital Clínic de Barcelona
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연락하다:
- Xavier Freixa Rofastes, Dr. MD
- 전화번호: +34-934-518-746
- 이메일: freixa@clinic.cat
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연락하다:
- Anna Campos
- 이메일: acampos@clinic.cat
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수석 연구원:
- Xavier Freixa Rofastes, Dr.
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Salamanca, 스페인, 37007
- Hospital Universitario de Salamanca
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연락하다:
- Ignacio Cruz González, Professor, MD
- 전화번호: +34-923-291-100
- 이메일: icruz@saludcastillayleon.es
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연락하다:
- Maria del Rocio Mendez Sanchez
- 이메일: mrmendezs.ibsal@saludcastillayleon.es
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수석 연구원:
- Ignacio Cruz González, Professor, MD, PhD
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Vigo, 스페인, 36312
- Complejo Hospitalario Universitario de Vigo
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수석 연구원:
- Rodrigo Estévez Loureiro, Dr.
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연락하다:
- Rodrigo Estévez Loureiro, Dr. MD
- 전화번호: +34-986-825-564
- 이메일: roiestevez@hotmail.com
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연락하다:
- Pablo Juan Pharma, PhD
- 전화번호: +34-986-825-564
- 이메일: pablo.juan@iisgaliciasur.es
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
To participate in this study, the patient must meet ALL of the following 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;
- Presence of ≥2 frailty indices (moderate to severe frailty);
- Presence of ≥2 major organ dysfunctions that could not be improved after surgery;
- Presence of other surgical high-risk comorbidities or factors as determined by the heart team.
- Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique, can be treated by the investigational device, and transseptal catheterization and femoral vein access is determined to be feasible.
- Patients who voluntarily participate in the study and sign the informed consent form (ICF), and are willing to undergo the required examinations and clinical follow-up visits.
Exclusion Criteria:
Patients will be excluded if ANY of the following conditions apply:
- 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;
- Patients with unfavorable mitral valve anatomy for mitral valve clip placement, including but not limited to a mitral valve orifice area less than 4 cm²;
- Patients with a history of heart transplantation, prior mitral valve surgery, or previous mitral valve transcatheter procedures;
- Patients with severe pulmonary hypertension (pulmonary artery systolic pressure > 70 mmHg, assessed by echocardiography or right heart catheterization, with right heart catheterization taking precedence in cases of concurrent measurement);
- Patients with moderate-to-severe or severe right ventricular dysfunction as demonstrated by echocardiographic findings;
- Patients with thrombi located in the inferior vena cava or femoral vein, presence of inferior vena cava filters, tortuous or obstructed venous anatomy, or other venous access limitations;
- Patients unable to participate the 6-minute walk test;
- Presence of diseases that may complicate the evaluation of treatment outcomes (e.g., coma, cancer, psychiatric disorders);
- Pregnant or breastfeeding women, as well as women planning to become pregnant within the next 12 months;
- Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator;
- Patient is currently participating in another investigational drug or device clinical study;
- Any other conditions deemed by the investigator to render the subject unsuitable for participation in the clinical study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: X-Clip Mitral Valve Clip System
Adult patients with moderate-to-severe or severe primary/degenerative mitral regurgitation (MR ≥3+) treated with the X-Clip Mitral Valve Clip System for transcatheter mitral valve repair.
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Adult patients with moderate-to-severe or severe primary/degenerative mitral regurgitation (MR ≥3+) undergoing transcatheter mitral valve repair using the X-Clip Mitral Valve Clip System.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of major adverse events (MAEs) within 30 days after operation
기간: At pre-discharge, 30 days ± 7 days post-procedure
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MAEs are defined as cardiovascular mortality, stroke, myocardial infarction, renal replacement therapy (e.g., dialysis), severe bleeding, and mitral valve reintervention (either transcatheter or surgical). Note: MAEs are defined per Mitral Valve Academic Research Consortium (MVARC). Severe bleeding is major, extensive, life-threatening or fatal bleeding defined by the Mitral Valve Academic Research Consortium. |
At pre-discharge, 30 days ± 7 days post-procedure
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Clinical success rate
기간: At 12 months ± 30 days post-procedure
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Clinical success is defined as freedom from mortality, reintervention for mitral valve dysfunction, and moderate-to-severe or severe mitral regurgitation (grade≥3+) at the 12-month postoperative follow-up. Note: *Mitral severity is evaluated through transthoracic echocardiography (TTE) or transoesophageal echocardiography (TEE). |
At 12 months ± 30 days post-procedure
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of major adverse events (MAEs)
기간: At 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
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Evaluation method: Evaluating and recording the number of subjects experiencing MAEs at 6 months ± 30 days and 12 months ± 30 days post-procedure. Calculation formula: Incidence of MAEs = (Number of subjects with MAEs / Total number of subjects) × 100% |
At 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
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All-cause mortality
기간: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
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Evaluation method: All-cause mortality is defined as death from any cause, regardless of its relationship to the investigational device. However, when a death occurs, the cause of death (cardiovascular-related or non-cardiovascular-related) should be determined. Deaths for which no clear cause can be determined are classified as cardiovascular-related. The number of all-cause mortality subjects is recorded at immediate post-procedure, and 7 days ± 5 days, 30 days ± 7 days, 6 months ± 30 days, 12 months ± 30 days, 24 months ± 60 days, 36 months ± 60 days, 48 months ± 60 days, and 60 months ± 60 days post-procedure. Calculation formula: All-cause mortality = (Number of all-cause mortality subjects / Total number of subjects) × 100%. |
From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
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Cardiac mortality
기간: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
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Evaluation method: The number of cardiac mortality subjects is recorded at immediate post-procedure, and 7 days ± 5 days, 30 days ± 7 days, 6 months ± 30 days, 12 months ± 30 days, 24 months ± 60 days, 36 months ± 60 days, 48 months ± 60 days, and 60 months ± 60 days post-procedure. Calculation formula: Cardiac mortality = (Number of cardiac mortality subjects / Total number of subjects) × 100%. |
From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
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Incidence of adverse events (AEs)
기간: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
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Evaluation method: The types, incidences (%), and frequencies (number of occurrences) of AEs are recorded during the study period.
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From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
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Incidence of serious adverse events (SAEs)
기간: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
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Evaluation method: The types, incidences (%), and frequencies (number of occurrences) of SAEs are recorded during the study period.
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From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
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Clinical success rate
기간: At 30 days ± 7 days post-procedure, 6 months ± 30 days post-procedure
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Evaluation method: Assessing and recording the number of subjects who experience no mortality, no reintervention for mitral valve dysfunction, and no moderate-to-severe or severe mitral regurgitation (≥3+) at 30 days ± 7 days and 6 months ± 30 days post-procedure. Calculation formula: Clinical success rate = (Number of clinical success subjects / Total number of subjects) × 100% |
At 30 days ± 7 days post-procedure, 6 months ± 30 days post-procedure
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Proportion of patients with New York Heart Association (NYHA) Function Class I or II
기간: At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
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Evaluation method: Evaluating and recording the number of subjects with NYHA function class I or II at 30 days ± 7 days, 6 months ± 30 days and 12 months ± 30 days post-procedure. Calculation formula: Proportion of patients with NYHA Function Class I or II = (Number of subjects with NYHA function class I or II / Total number of subjects) × 100% |
At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
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Incidence of heart failure hospitalization (HFH)
기간: At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
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Evaluation method: Evaluating and recording the number of subjects experiencing HFH at 30 days ± 7 days, 6 months ± 30 days and 12 months ± 30 days post-procedure. Calculation formula: Incidence of HFH = (Number of subjects experiencing HFH / Total number of subjects) × 100% |
At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
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Quality-of-life score
기간: At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
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Evaluation method: Quality-of-life score is measured by Short-Form 36 Health Survey Questionnaire (SF-36) at 1-, 6-, and 12-months post-procedure and is compared with each patient's baseline scores.
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At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
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Change in mean 6 min walking distance (M6WD)
기간: At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
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Evaluation method: The change in M6WD is measured using the 6-minute walk test (6MWT) at 1-, 6-, and 12-months post-procedure and is compared with each patient's baseline distance.
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At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
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Change of left ventricular function
기간: At immediate post-procedure; 7 days ± 5 days post-procedure; 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
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Evaluation method: Left ventricular function is assessed using parameters including left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), left ventricular end-systolic diameter (LVESD), and left ventricular end-diastolic diameter (LVEDD).
Each parameter is measured at immediate post-procedure, and 7 days ± 5 days, 30 days ± 7 days, 6 months ± 30 days and 12 months ± 30 days post-procedure, and compared with each patient's baseline values.
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At immediate post-procedure; 7 days ± 5 days post-procedure; 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
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Change of mitral regurgitation degree
기간: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
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Evaluation method: The mitral regurgitation degree of each subject is assessed according to Annex VIII: Evaluation of Mitral Regurgitation Severity, at immediate post-procedure, and 7 days ± 5 days, 30 days ± 7 days, 6 months ± 30 days, 12 months ± 30 days post-procedure, 24 months ± 60 days post-procedure, 36 months ± 60 days post-procedure, 48 months ± 60 days post-procedure, and 60 months ± 60 days post-procedure.
The results are compared with each patients' baseline degree.
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From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ignacio Cruz González, Professor, MD, PhD, University of Salamanca
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- LT-TS-P119-2026-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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