Transcatheter Mitral Valve Repair of Degenerative Mitral RegurgitationNCT07660185
A Clinical Study of X-Clip Mitral Valve Clip System and Steerable Guide System for Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation
A study testing X-Clip Treatment for Degenerative Mitral Regurgitation in people with Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation, run by Shenzhen Lifevalve Medical Scientific Co., Ltd. at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation
- What is being tested?
- X-Clip Treatment for Degenerative Mitral Regurgitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Mar 2027to 31 Aug 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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.
Who cannot join
- 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;
Show all 20Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nora Wu, APM contact
Spain3 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Xavier Freixa Rofastes, Dr. MD, +34-934-518-746, freixa@clinic.cat
Anna Campos, acampos@clinic.cat
Hospital Universitario de Salamanca
Salamanca, 37007
Ignacio Cruz González, Professor, MD, +34-923-291-100, icruz@saludcastillayleon.es
Maria del Rocio Mendez Sanchez, mrmendezs.ibsal@saludcastillayleon.es
Complejo Hospitalario Universitario de Vigo
Vigo, 36312
Rodrigo Estévez Loureiro, Dr. MD, +34-986-825-564, roiestevez@hotmail.com
Pablo Juan Pharma, PhD, +34-986-825-564, pablo.juan@iisgaliciasur.es
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- X-Clip Treatment for Degenerative Mitral Regurgitation
- Keywords
- X-Clip, Mitral regurgitation (MR), mitral regurgitation, Lifevalve X-Clip
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-Clip Treatment for Degenerative Mitral RegurgitationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| X-Clip Mitral Valve Clip System | Experimental | 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. Receives: Device: X-Clip Treatment for Degenerative Mitral Regurgitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse events (MAEs) within 30 days after operation
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.
Measured: At pre-discharge, 30 days ± 7 days post-procedure
Clinical success rate
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).
Measured: At 12 months ± 30 days post-procedure
Secondary outcomes (12)
Incidence of major adverse events (MAEs)
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%
Measured: At 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
All-cause mortality
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%.
Measured: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
Cardiac mortality
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%.
Measured: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
Incidence of adverse events (AEs)
Evaluation method: The types, incidences (%), and frequencies (number of occurrences) of AEs are recorded during the study period.
Measured: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
Incidence of serious adverse events (SAEs)
Evaluation method: The types, incidences (%), and frequencies (number of occurrences) of SAEs are recorded during the study period.
Measured: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
Clinical success rate
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%
Measured: 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
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%
Measured: 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)
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%
Measured: At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
Quality-of-life score
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.
Measured: 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)
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.
Measured: At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
Change of left ventricular function
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.
Measured: 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
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.
Measured: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Mar 2027 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Mitral Valve Repair of Degenerative Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a multi-centre, prospective, single-arm clinical study to evaluate the safety and performance of the X-Clip Mitral Valve Clip System and Steerable Guide System in European population.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Lifevalve Medical Scientific Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Ignacio Cruz González, Professor, MD, PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660185
- Sponsor's protocol ID
- LT-TS-P119-2026-01
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Need a further discuss with investigators
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07660185
- Acronym / sponsor ID
- LT-TS-P119-2026-01
- Keywords
- X-Clip, Mitral regurgitation (MR), mitral regurgitation, Lifevalve X-Clip
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shenzhen Lifevalve Medical Scientific Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Aug 2032 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a multi-centre, prospective, single-arm clinical study to evaluate the safety and performance of the X-Clip Mitral Valve Clip System and Steerable Guide System in European population.
| Arm | Type | Receives |
|---|---|---|
| X-Clip Mitral Valve Clip System | Experimental | Device: X-Clip Treatment for Degenerative Mitral RegurgitationAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X-Clip Treatment for Degenerative Mitral RegurgitationAdult 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. | Device | X-Clip Mitral Valve Clip System |
Primary outcome
Incidence of major adverse events (MAEs) within 30 days after operation
Time frame: 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.
Clinical success rate
Time frame: 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).
12 secondary outcomes
Incidence of major adverse events (MAEs)
Time frame: At 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
All-cause mortality
Time frame: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
Cardiac mortality
Time frame: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
Incidence of adverse events (AEs)
Time frame: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
Incidence of serious adverse events (SAEs)
Time frame: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
Clinical success rate
Time frame: 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
Time frame: 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)
Time frame: At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
Quality-of-life score
Time frame: 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)
Time frame: At 30 days ± 7 days post-procedure; 6 months ± 30 days post-procedure; 12 months ± 30 days post-procedure
Change of left ventricular function
Time frame: 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
Time frame: From immediate post-procedure to the end of treatment at 5 years ± 60 days post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No. Need a further discuss with investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nora Wu, APM contact
Ignacio Cruz González, Professor, MD, PhD principal investigator
University of Salamanca
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X-Clip Treatment for Degenerative Mitral Regurgitation in people with Transcatheter Mitral Valve Repair of Degenerative Mitral Regurgitation, run by Shenzhen Lifevalve Medical Scientific Co., Ltd. at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kadir Shemsi, CTM (0852-91426007, kadirr@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse events (MAEs) within 30 days after operation (time frame: At pre-discharge, 30 days ± 7 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.