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

A Prospective, Multicenter, Single Arm Study to Evaluate the Safety and Effectiveness of Shenqi Transcatheter Mitral Valve Clips Delivery System and Steerable Guide Catheters in Patients with Functional Mitral Regurgitation

The investigation objective of this study is to evaluate the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in the population of FMR patients and the accessories devices when used in conjunction with the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter.

Study Overview

• Status: Recruiting
• Conditions: Functional Mitral Regurgitation
• Intervention / Treatment: Device: SQ-Kyrin Transcatheter Mitral Valve Repair System

Detailed Description

The primary objective is to verify the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter produced by Shanghai Shenqi Medical Technology Co., Ltd. In the treatment of patients with moderate-severe (3 +) or severe (4 +) FMR whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Director; Phone Number: +86 13636491192; Email: chaojun.gu@sqmedical.com

Study Locations

• Spain
  • Valladolid, Spain, 47003
    • Recruiting
    • Hospital Clinico Universitario de Valladolid
    • Contact: Ignacio J Amat-Santos, MD, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participant who has provided written informed consent for the investigation.
2. Age ≥18 years.
3. Patients diagnosed with FMR.
4. MR severity is (functional) ≥3+ as determined by transthoracic echocardiography (TTE).
5. LVEF ≥20% to ≤60%.
6. Symptom status: NYHA functional class II to IV despite a stable maximally tolerated GDMT regimen as per guidelines.
7. According to the judgment of local cardiology team, subjects have undergone adequate treatment for at least 30 days (preferably 90 days) based on the criteria recommended in the heart failure guidelines.
8. Subject fulfils FMR anatomy selection criteria.
9. According to the judgment of the local Cardiovascular medical-surgery team, subjects who have high or prohibitive risk for open heart surgery.
10. Left ventricular end-systolic diameter (LVESD)≤70mm.
11. The MR beam mainly originates from the A2/P2 area.
12. Mitral valve coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets>10mm.
13. Mitral valve effective orifice area (EOA) ≥ 4.0cm2.
14. No obvious calcification of main grasp mitral valve leaflets.
15. Patient anatomy allows atrial septum approach.

Exclusion Criteria:

1. Life expectancy <1 year due to non-cardiac conditions or heart failure deemed suitable for palliative treatment.
2. Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support.
3. UNOS status 1 heart transplantation or prior orthotopic heart transplantation.
4. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
5. Fixed pulmonary artery systolic pressure >70 mm Hg.
6. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.
7. Mitral valve anatomy which may preclude proper device treatment.
8. Mitral valve area < 4.0 cm2 (if new device therapy may further decrease the mitral orifice area).
9. Any prior mitral valve surgery or transcatheter mitral valve procedure.
10. Stroke or transient ischemic event within 30 days before enrolment.
11. Modified Rankin ≥ Scale 4 disability.
12. Severe symptomatic carotid stenosis (>70% by ultrasound).
13. Need for emergent or urgent intervention for any reason or any planned cardiac intervention within the next 12 months.
14. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within 1 month before enrolment.
15. Untreated clinically significant coronary artery disease requiring revascularization.
16. Any percutaneous cardiovascular intervention, cardiovascular intervention, or carotid intervention within 30 days
17. Tricuspid valve disease requiring intervention or severe or more tricuspid regurgitation.
18. Aortic valve disease requiring intervention or any concomitant treatment.
19. Need for any cardiovascular intervention (other than for MV disease).
20. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
21. Active endocarditis.
22. Active infections requiring current antibiotic therapy.
23. Subjects in whom transoesophageal echocardiography is contraindicated or high risk.
24. Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits.
25. Patient unable or unwilling to provide written, informed consent before study enrolment.
26. Pregnant woman or woman planning to become pregnant.
27. Patients with severe liver, renal or pulmonary disease, which in investigator opinion may have an impact on patient safety.
28. Clinically significant lab abnormalities which in investigator opinion may have an impact on patient safety.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SQ-Kyrin TMVr System	Device: SQ-Kyrin Transcatheter Mitral Valve Repair System; To percutaneously repair the mitral valve via the femoral vein and atrial septum, offering a treatment for symptomatic functional mitral regurgitation through edge-to-edge valve clipping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with composite measures- All-cause death and recurrent hospitalizations due to heart failure	A composite of all-cause death and recurrent hospitalizations due to heart failure	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	Defined by the following four conditions: 1. No procedural mortality. 2. Successful delivery, implant, retrieval of the delivery system. 3. Successful devices release. 4. No need for any emergency surgery related to the device or surgical approach.	immediately after intervention
Device success rate	Defined by the following three conditions: 1. Technical success maintained at day 30. 2. Transthoracic echocardiographic assessment showing MR ≤2+ without significant mitral stenosis. 3. No structural or functional failure of the device.	30 days
Procedural success rate	Defined by following two conditions: 1. Device success. 2. No major adverse events occurred.	30 days
The rate of New York Heart Association (NYHA) heart function class I or II		On the day of discharge, 30 days, 6 months, and 12 months
Improvement in quality of life from baseline	Improvement in quality of life (QoL) at 12 months over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score, scale from 0 - 100, and higher scores mean a better outcome.	12 months
Rate of MR 2+ or less than 2+	Mitral regurgitation severity grade 2+ or less than 2+	30 days, 6 months, and 12 months
Change from baseline to discharge in MR severity assessed by echocardiography.		On the day of discharge
Rate of hospitalization for heart failure		30 days, 6 months, and 12 months
Improvement by ≥ 50m in 6-minute walk distance from baseline		12 months
Improvement in left ventricular end-diastolic volume (LVEDV) from baseline		12 months
Incidence of all-cause mortality		30 days, 6 months, and 12 months
Cardiovascular-related mortality		30 days, 6 months, and 12 months
Incidence of major adverse events	The major adverse event refers to the composite endpoint of death, stroke, myocardial infarction, and cardiovascular surgery due to device- or interventional-related adverse events that occurred since successful transfemoral vein puncture and establishment of atrial septal pathway.	30 days and 12 months

Collaborators and Investigators

• Sponsor: Shanghai Shenqi Medical Technology Co., Ltd
• Investigators: Principal Investigator: Ignacio J Amat-Santos, MD, Ph.D, Hospital Clinico Universitario de Valladolid

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: February 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 8, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: MVRP01-001C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No