Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China

Mitral Regurgitation Clinical Trial

Official title:

A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System for the Treatment of Moderate-severe or Severe Mitral Regurgitation With Single-arm Objective Performance Criteria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05610566
• Other study ID #: 23CSP001
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2022
• Est. completion date: July 6, 2029

Study information

• Verified date: November 2022
• Source: Peijia Medical Technology (Suzhou) Co., Ltd.
• Contact: Kejing Yi
• Phone: +86-13801858760
• Email: yikejing[@]peijiamedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To observe and evaluate the safety and efficacy of the HighLife Transcatheter Mitral Valve Replacement System in patients with moderate-severe or severe mitral valve regurgitation through a prospective, multicenter clinical trial using objective performance criteria.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 6, 2029
• Est. primary completion date: July 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who voluntarily participate and sign the informed consent form and can cooperate with the completion of the entire trial process;

2. Age = 18 years old;

3. Moderate-severe or severe mitral regurgitation (=3+); Note 1: Patients with ischemic or non-ischemic heart disease induced symptomatic secondary mitral regurgitation as the primary cause must be treated for at least 1 month after optimal guideline medical therapy (GDMT). Echocardiography should be performed 3 months after cardiac resynchronization therapy and 1 month after coronary revascularization to assess the degree of regurgitation.

Note 2: For patients with primary mitral regurgitation, the multidisciplinary cardiac team of the research center needs to use a standard scoring system, considering multiple factors such as complications, frailty, and disability, ensuring the enrolled with a high risk of surgery.

4. Patients with New York Heart Association (NYHA) functional ratings are Class II, III, or ambulatory Class IV;

5. Anatomically appropriate for treatment with the HighLife Transcatheter Mitral Valve Replacement System.

Exclusion Criteria:

1. Patients had any stroke/TIA within 30 days;

2. Patients with severe symptomatic bilateral carotid stenosis (>70% stenosis on non-invasive imaging);

3. Patients with active infection requiring antibiotic therapy;

4. Patients with active ulcer or gastrointestinal bleeding within the past 3 months;

5. Patients with history of coagulopathy or refuse future blood transfusion;

6. Patients unable to undergo transesophageal echocardiography (TEE);

7. Patients who are pregnant or breastfeeding, or planning to have children within 12 months;

8. Patients who are unable to adhere to the follow-up schedule and complete the examination;

9. Patients enrolled in other clinical studies and within the follow-up period;

10. Patients with known allergies to device components or contrast agents;

11. Patients unable to receive anticoagulant or antiplatelet therapy;

12. Patients with a life expectancy of less than 12 months due to non-cardiac disease;

13. Patients requiring emergency surgical treatment;

14. Patients scheduled for cardiac surgery within 12 months;

15. Patients with an inappropriate mitral annulus or leaflet size (<30 mm and >45 mm);

16. Patients with moderate or above mitral stenosis;

17. Flail mitral leaflets, or moderate to severe mitral valve prolapse;

18. Patients with severe hepatic or renal insufficiency;

19. Patients with severe calcification of the mitral annulus and/or mitral leaflets;

20. Patients with history of mitral valve surgery or interventional therapy, or left atrial appendage occlusion device;

21. Patients had acute myocardial infarction (MI) (Q-wave MI, or non-Q-wave MI, with CK-MB twice the normal and/or T-MB) within the past 1 month;

22. Patients with untreated symptomatic coronary lesions requiring revascularization;

23. Patients with untreated severe aortic stenosis and severe aortic regurgitation;

24. Patients with aortic valve prosthesis;

25. Patients with severe tricuspid valve lesions requiring surgical intervention;

26. Patients with significant right ventricular dysfunction (such as biliteral lower extremities edema with increased jugular vein pulsation and hepatomegaly;

27. LVEF < 30%; LVEDD > 70 mm;

28. Patients with echocardiographically confirmed intracardiac mass, thrombus or neoplasm;

29. Hypertrophic obstructive cardiomyopathy (HOCM);

30. Patients with active or recent (within 3 months) endocarditis;

31. Patients with definite non-left heart disease induced severe pulmonary hypertension (echocardiographic indication: systolic pulmonary artery pressure (SPAP) > 70 mmHg)

32. Patients with hypotension (systolic blood pressure <90 mmHg) occurring within 7 days or mechanical hemodynamic support.

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System
The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a subannular implant (SAI), and their delivery systems and accessories. The TMV is a 28mm mitral bioprosthesis made of a self-expanding Nitinol frame covered with polyester graft and supporting bovine pericardium leaflets. The bioprosthesis is used in conjunction with the Sub-Annular Implant (SAI), comprising a ring (made of polycarbonate urethane (PCU), nitinol, gold markers and polyester (Dacron) to be placed around the mitral valve apparatus to stabilize the position of the mitral valve implant.

Locations

Country	Name	City	State
China	Peiga Medical Technology (Suzhou) Co.	Suzhou	Jiangsu

Sponsors (4)

Lead Sponsor	Collaborator
Peijia Medical Technology (Suzhou) Co., Ltd.	Second Affiliated Hospital, School of Medicine, Zhejiang University, The Second Affiliated Hospital of Harbin Medical University, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Operative complication	The rate of operative complication	Immediately after procedure
Other	The incidence of major adverse cardiovascular and cerebrovascular events during the trial(MACCEs)	Incidence of MACCEs (mortality, stroke, myocardial infarction, and so on surgery, arrhythmias, conduction blocks) during the trial	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Other	Incidence of major adverse valve-related events (MAVREs) during the trial	including prosthetic valve-related death, permanent cardiac pacemaker implantation, permanent cardiac defibrillator implantation, prosthetic valve embolism, prosthetic valve thrombosis, prosthetic valve dysfunction.	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Primary	All-cause mortality at 12 months	All-cause mortality	12 months
Secondary	Technical success	Technical success defined as an alive patient at exit from procedure room, with all of the following: Successful vascular access, delivery and retrieval of the HighLife delivery systems; Deployment and correct positioning of the HighLife 28mm bioprosthesis; Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE.	Immediate after procedure
Secondary	Cardiac function change	NYHA functional classification	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Secondary	Quality of life of patients	Quality of Life of patients accessed by EuroQol-5 Dimensions (EQ-5D) Questionnaire. The higher scores mean a worse health state. Recording changes from baseline.	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years