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Mitral Valve InsufficiencyNCT05508438

To Evaluate the Efficacy and Safety of the Transfemoral Mitral Valve Repair System in the Treatment of Patients With Moderately Severe and Severe Functional Mitral Regurgitation(FMR) Who Remained Clinically Symptomatic After Guideline-directed Medical Treatment

A study testing Transfemoral mitral-valve repair in people with Mitral Valve Insufficiency, run by Pan Xiangbin at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

To confirm the effectiveness and safety of the transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mitral Valve Insufficiency
What is being tested?
Transfemoral mitral-valve repair
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteChina
Study dates
30 Aug 2022to 30 Dec 2027
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

  • 1.Age ≥ 18 yrs；
  • 2. Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy
  • Note 1: Functional MR requires the presence of overall or localized left ventricular wall motion abnormalities that are considered to be the primary cause of MR. Despite the eligibility, subjects may not enroll if leaflet prolapse or other evidence of degenerative MR is present.
  • Note 2: An Eligible transthoracic echocardiography must be obtained at least 30 days after the subject has been stabilized on optimal therapy with Guideline Directed Medical Therapy (GDMT), or at least 30 days under the following conditions after meeting two of the following conditions：Coronary revascularization and/or implantation of a cardiac resynchronization therapy device (CRT-P or CRT-D) or reprogramming of the implanted CRT-P or CRT-D resulting in an increase in biventricular pacing (from <92% to ≥92%).
  • 3. Subjects have been adequately treated according to applicable criteria, including treatment for coronary artery disease, left ventricular dysfunction, mitral regurgitation, and heart failure (e.g., with cardiac resynchronization therapy (CRT or CRT-D), coronary revascularization, and/or have received stable GDMT, confirmed by the local heart team;
  • 4. NYHA functional class II to IV;
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  • 5. Left ventricular ejection fraction (LVEF) ≥20%;
  • 6. Left ventricular end-systolic dimension (LVESD) ≤ 70 mm;
  • 7. The subject's mitral valve is anatomically suitable for mitral valve repair;
  • 8. Elevated BNP >150 pg/ml or corrected NT-proBNP ≥600 pg/ml or heart failure hospitalization within the past 12 months ('corrected' refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2);
  • 9. After evaluation, the femoral vein approach is suitable and the puncture through atrial septum is feasible;
  • 10. The subjects have been informed of the nature of this study, understand the purpose of the clinical trial, and voluntarily participate in and sign the informed consent form.

Who cannot join

  • 1) Echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
  • 2) The presence of other severe heart valve disease requiring surgical intervention.;
  • 3) After mitral valve surgery or mitral valve transcatheter surgery;
  • 4)Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis, etc.), or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.;
  • 5) Autoimmune myocarditis;
  • 6) Heart failure caused by tachyarrhythmia is effective after GDMT treatment;
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  • 7) Moderate to severe right heart dysfunction or an estimated pulmonary artery systolic pressure (PASP) > 70 mmHg assessed by echocardiography;
  • 8) History of acute myocardial infarction in the prior 4 weeks or untreated clinically significant coronary artery disease requiring revascularization;
  • 9) Any percutaneous cardiac intervention within the 30 days, or any cardiac surgery within the 6 months prior to randomization, or any implant of any Cardiac Resynchronization Therapy (CRT-P) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) or Implantable Cardioverter Defibrillator (ICD) within the last 30days prior to subject registration，or patients who meet the indications of CRT-P and CRT-D but are not implanted;
  • 10) In the judgment of the investigator, the subject's femoral vein is unable to accommodate a 22F catheter or has an ipsilateral deep venous thrombosis; or the anatomy is not accessible for transseptal puncture;
  • 11)) Subjects in whom transesophageal echocardiography (TEE) or general anesthesia is contraindicated;
  • 12) End-stage heart failure (ACC/AHA stage D), or prior orthotopic heart transplantation, or on the waiting list for heart transplantation.；
  • 13) Active endocarditis; Or valvular degeneration caused by active rheumatic heart disease or rheumatic disease (such as poor compliance, perforation, etc)；
  • 14) Severe Chronic Obstructive Pulmonary Disease (COPD) (requiring continuous home oxygen therapy or long-term application of steroid hormone medication)；
  • 15) Cerebrovascular accident within 30 days prior to randomization or symptomatic severe carotid stenosis (> 70% by ultrasound), carotid artery stenting within 30 days.；Cerebrovascular accident (hemorrhagic) within 6 months；
  • 16) History of acute peptic ulcer or gastrointestinal bleeding within 3 months；
  • 17)Hemorrhagic or coagulopathic disorders, contraindications to antithrombotic medication；
  • 18) Modified Rankin Scale ≥4.；
  • 19) The subjects suffer from diseases that may lead to difficulty in evaluating treatment (e.g., cancer, severe metabolic disease, psychosis, etc.)；
  • 20）Pregnant or breastfeeding women, or women who plan to become pregnant within the next 12 months.
  • Note: Women of childbearing age should take a pregnancy test with a negative result within 14 days prior to registration and use scientifically safe contraception；
  • 21) Hemodynamic instability defined as systolic pressure < 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or an intra-aortic balloon pump；
  • 22) Active infections requiring antibiotic therapy (in the case of temporary illness, antibiotics must be discontinued for at least 14 days before the subject can be enrolled).；
  • 23) Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials；
  • 24) In the judgment of the investigator, subjects may not complete the trial according to poor compliance or in other circumstances when the investigator determines that the subject is unfit to participate in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yueyan li contact

+86 15189109112

yyli@kokalife.com

China1 site

  • Structral Heart Disease Center, Fuwai Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Prospective, Multicenter, Objective Performance Criteria Clinical Study to Evaluate the Efficacy and Safety of the Transfemoral Mitral Valve Repair System in the Treatment of Patients With Moderately Severe and Severe Functional Mitral Regurgitation(FMR)

To confirm the effectiveness and safety of the transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment.

Read the detailed description

This study is a prospective, multicenter, objective performance criteria clinical design.Patients are moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment. All subjects receive clinical follow-up immediately after procedure, before discharge, 30 days after procedure, 6 months after transfemoral mitral-valve repair, 12 months and 2 yeas，3 years，4 years after Transfemoral mitral-valve repair.

The primary outcome is defined as all-cause death and rehospitalization due to heart failure 12 months after Transfemoral mitral-valve repair.

The secondary outcomes include：Rate of rehospitalization due to heart failure after operation；Rate of postoperative mitral regurgitation (MR ≤ 2+)；Rate of New York Heart Association (NYHA) Function Class I or II after Transfemoral mitral-valve repair；Change in 6 minutes walk test distance；Improvement value of quality of life changes assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)；Echocardiographic changes in left ventricular end diastolic volume (LVEDV) from baseline；Acute procedural success，Acute device success.

Being tested
Transfemoral mitral-valve repair
Keywords
Heart Valve Disease, Cardiovascular Diseases
Medical subject headings
Mitral Valve Insufficiency, Heart Valve Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transfemoral mitral-valve repairDevice

    Transfemoral mitral-valve repair

Study groups in NCT05508438
Study groupRoleWhat they receive
Treatment GroupOtherNot described
Receives: Device: Transfemoral mitral-valve repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The composite endpoint of all-cause mortality and rehospitalization due to heart failure 12 months after Transfemoral mitral-valve repair

    All-cause mortality and rehospitalization due to heart failure

    Measured: 12 months after Transfemoral mitral-valve repair

Secondary outcomes (8)

  1. rehospitalization

    The rate of rehospitalization due to heart failure

    Measured: 30 days,6 months,12months after Transfemoral mitral-valve repair

  2. postoperative

    The rate of postoperative mitral regurgitation (MR ≤ 2+)

    Measured: 30 days,6 months,12months after Transfemoral mitral-valve repair

  3. New York Heart Association (NYHA)

    The rate of New York Heart Association (NYHA) Function Class I or II.

    Measured: 30 days,6 months,12months after Transfemoral mitral-valve repair

  4. walk test

    Change in 6-minutes walk test distance.

    Measured: 12 months after Transfemoral mitral-valve repair

  5. Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Improvement value of quality of life changes assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Measured: 12 months after Transfemoral mitral-valve repair

  6. left ventricular end diastolic volume (LVEDV)

    Echocardiographic changes in left ventricular end diastolic volume (LVEDV) from

    Measured: 12 months after Transfemoral mitral-valve repair

  7. procedural success

    Acute procedural success

    Measured: Before discharge

  8. device success

    Acute device success

    Measured: Immediately after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2022
  2. Study start30 Aug 2022 (estimated)
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05508438
Sponsor's protocol ID
KOKA-2021-02
Status last verified
Aug 2022
First submitted
21 Jul 2022
Last updated
19 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li H, Chen Y, Zhang J, Guo Y, Guo Q, Guo H, Gong J, Ni D, Wang F, Xue W, Duan F. TEERAI-Pre: A Multiview Artificial Intelligence Model for Preoperative Assessment of Transcatheter Edge-to-Edge Mitral Valve Repair Using Multiview, Multimodal Echocardiography. J Am Heart Assoc. 2026 Feb 3;15(3):e044333. doi: 10.1161/JAHA.125.044333. Epub 2026 Jan 30.

    PubMed 41614293

Questions about this trial

What is this clinical trial studying?

A study testing Transfemoral mitral-valve repair in people with Mitral Valve Insufficiency, run by Pan Xiangbin at 1 site in China.

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 25 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 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 Yueyan li (+86 15189109112, yyli@kokalife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The composite endpoint of all-cause mortality and rehospitalization due to heart failure 12 months after Transfemoral mitral-valve repair (time frame: 12 months after Transfemoral mitral-valve repair). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05508438, which also lists 1 linked publication.

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 19 Aug 2022.

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