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

Functional Mitral Regurgitation Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05988450
• Other study ID #: MVRP01-001A
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: December 2027

Study information

• Verified date: August 2023
• Source: Shanghai Shenqi Medical Technology Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: December 2027
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

11. Patients with clear contraindications to the use of anticoagulants;

12. Patients with stroke or transient cerebral ischemic attack within 30 days;

13. Received cardiac pacemaker therapy or cardiac resynchronization therapy (CRT, CRT-D) or implanted cardioverter-defibrillator (ICD) implantation therapy within 30 days;

14. Any intracardiac mass, left ventricular or atrial thrombus detected on transthoracic echocardiography;

15. Severe tricuspid TR;

16. Patients with other valve disease requiring surgery or interventional therapy;

17. Patients with severe macrovascular disease requiring surgical treatment;

18. Severe symptomatic carotid stenosis (>70% on ultrasonography) or carotid stenting within 30 days;

19. Patients with inappropriate anatomical structures of the heart and valves indicated by imaging examinations;

20. Known allergy to contrast agents and nickel-titanium memory alloy products;

21. <Resting systolic blood pressure 90 mmHg or >160 mmHg;

22. Patients with diseases that seriously affect the evaluation of treatment, such as patients with severe neurological lesions affecting cognitive ability, patients with malignant tumors, etc.;

23. Patient life expectancy < 12 months;

24. Patients with severe thoracic deformity;

25. Women who are pregnant, breastfeeding, or planning to become pregnant within the next 12 months.

Related Conditions & MeSH terms

• Functional Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• SQ-Kyrin Transcatheter Mitral Valve Repair System
Transcatheter mitral valve clip placement to repair the valve and correct regurgitation.

Locations

Country	Name	City	State
China	General Hospital of Northern Theater Command, PLA	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Shenqi Medical Technology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of all-cause death and hospitalization for heart failure	Freefrom of all-cause death and hospitalization for heart failure	12 months
Secondary	Technical success rate	No surgical death; Delivery system for successful delivery and retrieval of devices; Successful devices release and accurate positioning; No need for any emergency surgery related to the device or surgical approach	Immediate postoperative
Secondary	Device success rate	Successfully implanted valve clip; Transthoracic echocardiographic assessment showing MR =2+	30 days after surgery
Secondary	Surgical success rate	Device success; No major adverse events occurred The major adverse event refers to the composite endpoint of death, stroke, myocardial infarction, and cardiovascular surgery due to device- or surgery-related adverse events following the atrial septum pathway via the femoral vein.	30 days after surgery
Secondary	Rate of MR 2+ or less than 2+ at 30 days, 6 months, and 12 months 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
Secondary	Rate of hospitalization for heart failure at 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
Secondary	The rate of NYHA heart function class I or II at 30 days, 6 months, and 12 months after surgery;	The rate of NYHA heart function class I or II at 30 days, 6 months, and 12 months after surgery;	30 days, 6 months, and 12 months after surgery
Secondary	Improvement in quality of life from baseline at 12 months after surgery (as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score);	Improvement in quality of life from baseline at 12 months after surgery (as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score);	12 months after surgery
Secondary	Improvement in 6-minute walk distance from baseline at 12 months after surgery;	Improvement in 6-minute walk distance from baseline at 12 months after surgery;	12 months after surgery
Secondary	Improvement in left ventricular end-diastolic volume (LVEDV) from baseline at 12 months after surgery;	Improvement in left ventricular end-diastolic volume (LVEDV) from baseline at 12 months after surgery;	12 months after surgery