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A Clinical Study of X-Clip Mitral Valve Clip System and Steerable Guide System for Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation

16. juni 2026 opdateret af: Shenzhen Lifevalve Medical Scientific Co., Ltd.

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Spanien
      • Barcelona, Spanien, 08036
        • Hospital Clínic de Barcelona
        • Kontakt:
          • Xavier Freixa Rofastes, Dr. MD
          • Telefonnummer: +34-934-518-746
          • E-mail: freixa@clinic.cat
        • Kontakt:
        • Ledende efterforsker:
          • Xavier Freixa Rofastes, Dr.
      • Salamanca, Spanien, 37007
      • Vigo, Spanien, 36312
        • Complejo Hospitalario Universitario de Vigo
        • Ledende efterforsker:
          • Rodrigo Estévez Loureiro, Dr.
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

To participate in this study, the patient must meet ALL of the following inclusion criteria:

  1. 18 years of age or older, no gender limit;
  2. New York Heart Association function class II, III or IV;
  3. Moderate-to-severe or severe mitral valve regurgitation (grade≥3+) confirmed by transthoracic echocardiography or transesophageal echocardiography;
  4. Patients with symptoms, or without symptoms but with left ventricular ejection fraction (LVEF) ≤ 60% or left ventricular end-systolic diameter (LVESD) ≥ 40 mm;

  5. 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:

    1. The American Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) is ≥ 6% for valve repair or is ≥ 8% for valve replacement;
    2. Presence of ≥2 frailty indices (moderate to severe frailty);
    3. Presence of ≥2 major organ dysfunctions that could not be improved after surgery;
    4. Presence of other surgical high-risk comorbidities or factors as determined by the heart team.
  6. 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.
  7. 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:

  1. Patients who are unable to tolerate the treatment, including those with allergies or hypersensitivity to anticoagulant or antiplatelet agents;
  2. Patients with contraindications to antithrombotic medication, or those with a history of cerebral hemorrhage, gastrointestinal hemorrhage, or hemorrhagic disorders within the past 3 months;
  3. Patients known to have hypersensitivity or allergic reactions to nickel or titanium, cobalt, chromium, polyester, fluoropolymers, or contrast media;
  4. 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;
  5. Patients with active infections that significantly impact both the outcome of mitral valve transcatheter interventions and postoperative recovery;
  6. Patients with intracardiac thrombus, vegetations, or masses identified by echocardiography;
  7. Patients with coronary artery stenosis requiring revascularization, or those who have undergone coronary artery surgery within the past 30 days;
  8. Patients with aortic stenosis or regurgitation requiring surgical intervention, as well as those with other cardiac conditions necessitating surgical treatment, as judged by clinicians;
  9. 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;
  10. Patients with a history of heart transplantation, prior mitral valve surgery, or previous mitral valve transcatheter procedures;
  11. 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);
  12. Patients with moderate-to-severe or severe right ventricular dysfunction as demonstrated by echocardiographic findings;
  13. 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;
  14. Patients unable to participate the 6-minute walk test;
  15. Presence of diseases that may complicate the evaluation of treatment outcomes (e.g., coma, cancer, psychiatric disorders);
  16. Pregnant or breastfeeding women, as well as women planning to become pregnant within the next 12 months;
  17. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator;
  18. Patient is currently participating in another investigational drug or device clinical study;
  19. Any other conditions deemed by the investigator to render the subject unsuitable for participation in the clinical study.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: X-Clip Treatment for Degenerative Mitral Regurgitation
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of major adverse events (MAEs) within 30 days after operation
Tidsramme: At pre-discharge, 30 days ± 7 days post-procedure

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
Clinical success rate
Tidsramme: At 12 months ± 30 days post-procedure

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of major adverse events (MAEs)
Tidsramme: At 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure

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
All-cause mortality
Tidsramme: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure

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
Cardiac mortality
Tidsramme: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure

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
Incidence of adverse events (AEs)
Tidsramme: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
Evaluation method: The types, incidences (%), and frequencies (number of occurrences) of AEs are recorded during the study period.
From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
Incidence of serious adverse events (SAEs)
Tidsramme: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
Evaluation method: The types, incidences (%), and frequencies (number of occurrences) of SAEs are recorded during the study period.
From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
Clinical success rate
Tidsramme: At 30 days ± 7 days post-procedure, 6 months ± 30 days post-procedure

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
Proportion of patients with New York Heart Association (NYHA) Function Class I or II
Tidsramme: At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure

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
Incidence of heart failure hospitalization (HFH)
Tidsramme: At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure

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
Quality-of-life score
Tidsramme: At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
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.
At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
Change in mean 6 min walking distance (M6WD)
Tidsramme: At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
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.
At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
Change of left ventricular function
Tidsramme: 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
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.
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
Change of mitral regurgitation degree
Tidsramme: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
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.
From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shenzhen Lifevalve Medical Scientific Co., Ltd.

Samarbejdspartnere

Lifetech Scientific (Shenzhen) Co., Ltd.

Efterforskere

  • Ledende efterforsker: Ignacio Cruz González, Professor, MD, PhD, University of Salamanca

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. marts 2027

Primær færdiggørelse (Anslået)

31. maj 2028

Studieafslutning (Anslået)

31. august 2032

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LT-TS-P119-2026-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Need a further discuss with investigators

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation

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