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Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation | Clinical Trials | Clareo Health

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Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation

A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in Patients With Moderate-severe or Severe Functional MR (FMR)

NCT05988450•Shanghai Shenqi Medical Technology Co., Ltd

View on ClinicalTrials.gov

Summary

To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd. in patients with moderate-severe (3 +) or severe (4 +) functional MR (functional MR) who still have symptoms after full treatment.

Detailed Description

This study is a prospective, multi-center, single arm clinical study designed to evaluate the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter in patients with moderate-severe (3 +) or severe (4 +) functional MR (Functional MR) who still have symptoms after adequate treatment. This trial will be conducted at 41 sites in China and is planned to include a total of 118 subjects. All subjects received the trial device for transcatheter mitral valve clip delivery system and steerable guide catheter, and were followed up at 30 days, 6 months, and 12 months after surgery. The composite endpoint of all-cause death and hospitalization for heart failure was assessed at 12 months after surgery. After the 12th month follow-up, the statistical analysis, clinical summary and application for product registration were carried out.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Severe functional MR (FMR) ≥3+ as determined by transthoracic echocardiography (TTE);
•2. Note: Eligible TTE must be obtained at least 30 days after the subject has been stabilized on optimal therapy (including Guideline Directed Medical Therapy GDMT). In the judgment of the center's cardiac team, subjects have received adequate treatment according to applicable criteria, including treatment for coronary artery disease, left ventricular dysfunction, MR, and heart failure (e.g., with cardiac resynchronization therapy (CRT or CRT-D), implantable cardioverter-defibrillator (ICD) implantation, coronary revascularization, and stable GDMT (see Appendix III for the definition of GDMT).
•3. Age ≥ 18 years old, regardless of gender;
•4. Cardiac function classification NYHA class II, III or ambulatory IV a;
•5. At least one hospitalization for heart failure or subjects with high BNP \> 150 pg/ml or high NT-proBNP \> 600 pg/ml in the past 12 months.
•6. Note: BNP or NT-proBNP must be obtained after the subject has stabilized on optimal therapy including Guideline Directed Medical Therapy (GDMT) at least 30 days. The patients can understand the purpose of the trial, voluntarily participate and sign an informed consent form, and are willing to undergo relevant tests and clinical follow-up.
•7. Left ventricular end-systolic diameter (LVESD)≤70mm
•8. The MR beam mainly originates from the A2/P2 area
•9. Mitral valve coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets\>10mm
•10. Mitral valve effective orifice area (EOA) ≥ 4.0cm2

Exclusion Criteria

•1. History of mitral valve surgery;
•2. Patients with infective endocarditis or suggestive of active infection;
•3. Complicated with severe untreated coronary artery disease;
•4. Patients with pulmonary hypertension (pulmonary systolic blood pressure\>70mmHg);
•5. patients with transthoracic echocardiographic evidence of moderate-severe to severe right ventricular dysfunction;
•6. Left heart ejection fraction \<20%;
•7. Patients who are extremely frail and cannot tolerate general anesthesia surgery or is in the state of shock requiring circulatory support;
•8. Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;
•9. Severe renal insufficiency (eGFR ≤ 25 mL/min) or requiring chronic renal replacement therapy;
•10. Patients with definite coagulation disorders and severe coagulation system diseases;
+15 more criteria

Locations (1)

General Hospital of Northern Theater Command, PLA

Shenyang, Liaoning, China

Key Dates

Start Date

March 7, 2022

Primary Completion Date

December 1, 2023

Completion Date

December 1, 2027

Last Updated

August 14, 2023

Enrollment

125

ACTUAL participants

Conditions

Functional Mitral Regurgitation

Interventions

SQ-Kyrin Transcatheter Mitral Valve Repair System

DEVICE

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

NCT03142152

Functional Mitral RegurgitationHeart Failure+4 more

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RECRUITING

Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)

NCT06911099

Atrial Functional Mitral RegurgitationMitral Insufficiency

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation

Inclusion Criteria

Exclusion Criteria

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)

The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation

Dapagliflozin Effect on FunctiOnal Mitral Regurgitation and Myocardial Fibrosis (DEFORM)

An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation

Dapagliflozin Effect on FunctiOnal Mitral Regurgitation and Myocardial Remodeling