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

NCT05508438 | Not Yet Recruiting

• 1 other identifier: KOKA-2021-02
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitral Valve Insufficiency

Keywords

Heart Valve Disease; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (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

  12 months after Transfemoral mitral-valve repair

Secondary Outcomes (8)

• rehospitalization

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

• postoperative

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

• New York Heart Association (NYHA)

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

• walk test

  12 months after Transfemoral mitral-valve repair

• Kansas City Cardiomyopathy Questionnaire (KCCQ)

  12 months after Transfemoral mitral-valve repair

Study Arms (1)

Treatment Group

OTHER

Device: Transfemoral mitral-valve repair

Interventions

Transfemoral mitral-valve repair DEVICE

Transfemoral mitral-valve repair

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 yrs；
• \. 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%).
• \. 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;
• \. NYHA functional class II to IV;
• \. Left ventricular ejection fraction (LVEF) ≥20%;
• \. Left ventricular end-systolic dimension (LVESD) ≤ 70 mm;
• \. The subject's mitral valve is anatomically suitable for mitral valve repair;
• \. 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);
• \. After evaluation, the femoral vein approach is suitable and the puncture through atrial septum is feasible;
• \. 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.

You may not qualify if:

• \) Echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
• \) The presence of other severe heart valve disease requiring surgical intervention.;
• \) After mitral valve surgery or mitral valve transcatheter surgery;
• )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.;
• \) Autoimmune myocarditis;
• \) Heart failure caused by tachyarrhythmia is effective after GDMT treatment;
• \) Moderate to severe right heart dysfunction or an estimated pulmonary artery systolic pressure (PASP) \> 70 mmHg assessed by echocardiography;
• \) History of acute myocardial infarction in the prior 4 weeks or untreated clinically significant coronary artery disease requiring revascularization;
• \) 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;
• \) 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;
• )) Subjects in whom transesophageal echocardiography (TEE) or general anesthesia is contraindicated;
• \) End-stage heart failure (ACC/AHA stage D), or prior orthotopic heart transplantation, or on the waiting list for heart transplantation.；
• \) Active endocarditis; Or valvular degeneration caused by active rheumatic heart disease or rheumatic disease (such as poor compliance, perforation, etc)；
• \) Severe Chronic Obstructive Pulmonary Disease (COPD) (requiring continuous home oxygen therapy or long-term application of steroid hormone medication)；
• \) 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；

Sponsors & Collaborators

• Pan Xiangbin: lead

Study Sites (1)

Structral Heart Disease Center, Fuwai Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• 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 Jan 30:e044333. doi: 10.1161/JAHA.125.044333. Online ahead of print.

  PMID: 41614293 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency; Heart Valve Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Xiangbin Pan, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueyan li

CONTACT

+86 15189109112; yyli@kokalife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Department of Structural Heart DiseaseAffiliation

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: August 19, 2022
• Study Start: August 30, 2022
• Primary Completion: December 30, 2023
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)