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

NCT05988450 | Active Not Recruiting

• 1 other identifier: MVRP01-001A
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Mitral Regurgitation

Keywords

Functional Mitral Regurgitation; Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• Rate of all-cause death and hospitalization for heart failure

  Freefrom of all-cause death and hospitalization for heart failure

  12 months

Secondary Outcomes (9)

• Technical success rate

  Immediate postoperative

• Device success rate

  30 days after surgery

• Surgical success rate

  30 days after surgery

• Rate of MR 2+ or less than 2+ at 30 days, 6 months, and 12 months after surgery;

  30 days, 6 months, and 12 months after surgery

• Rate of hospitalization for heart failure at 30 days, 6 months, and 12 months after surgery;

  30 days, 6 months, and 12 months after surgery

Study Arms (1)

SQ-Kyrin TMVr System

EXPERIMENTAL

Transcatheter edge-to-edge mitral valve repair using SQ-Kyrin TMVr System.

Device: SQ-Kyrin Transcatheter Mitral Valve Repair System

Interventions

SQ-Kyrin Transcatheter Mitral Valve Repair System DEVICE

Transcatheter mitral valve clip placement to repair the valve and correct regurgitation.

SQ-Kyrin TMVr System

Eligibility Criteria

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

You may qualify if:

• Severe functional MR (FMR) ≥3+ as determined by transthoracic echocardiography (TTE);
• 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).
• Age ≥ 18 years old, regardless of gender;
• Cardiac function classification NYHA class II, III or ambulatory IV a;
• 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.
• 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.
• Left ventricular end-systolic diameter (LVESD)≤70mm
• The MR beam mainly originates from the A2/P2 area
• Mitral valve coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets\>10mm
• Mitral valve effective orifice area (EOA) ≥ 4.0cm2

You may not qualify if:

• History of mitral valve surgery;
• Patients with infective endocarditis or suggestive of active infection;
• Complicated with severe untreated coronary artery disease;
• Patients with pulmonary hypertension (pulmonary systolic blood pressure\>70mmHg);
• patients with transthoracic echocardiographic evidence of moderate-severe to severe right ventricular dysfunction;
• Left heart ejection fraction \<20%;
• Patients who are extremely frail and cannot tolerate general anesthesia surgery or is in the state of shock requiring circulatory support;
• Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;
• Severe renal insufficiency (eGFR ≤ 25 mL/min) or requiring chronic renal replacement therapy;
• Patients with definite coagulation disorders and severe coagulation system diseases;
• Patients with clear contraindications to the use of anticoagulants;
• Patients with stroke or transient cerebral ischemic attack within 30 days;
• Received cardiac pacemaker therapy or cardiac resynchronization therapy (CRT, CRT-D) or implanted cardioverter-defibrillator (ICD) implantation therapy within 30 days;
• Any intracardiac mass, left ventricular or atrial thrombus detected on transthoracic echocardiography;
• Severe tricuspid TR;

Sponsors & Collaborators

• Shanghai Shenqi Medical Technology Co., Ltd: lead

Study Sites (1)

General Hospital of Northern Theater Command, PLA

Shenyang, Liaoning, 123005, China

Location

Related Publications (1)

• Xu K, Zhu D, Jiang H, Chen J, Chen S, Zhang J, He B, Wang Y, Fu G, Chen J, An J, Xiu J, Guo X, Li Y, Cheng X, Li P, Chen Y, Zhou S, Sun Y, Yu B, Pan X, Han Y. One-Year Outcomes of Novel Transcatheter Edge-to-Edge Mitral Repair System in Patients With Functional Mitral Regurgitation. Catheter Cardiovasc Interv. 2025 Dec;106(7):3574-3582. doi: 10.1002/ccd.70230. Epub 2025 Oct 6.

  PMID: 41054211 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Yaling Han, MD, Ph.D

  General Hospital of Northern Theater Command, PLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: March 7, 2022
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)