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

NCT ID: NCT05610566

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-06
• Study Completion Date: 2029-07-06

Brief 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.

Conditions

Mitral Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A single set of test

The HighLife Trans-Septal TMVR System comprises a 28mm Transcatheter Mitral Valve, a loop placement catheter, a sub-annular implant and its delivery systems.

Group Type: EXPERIMENTAL

the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: collaborator

Peijia Medical Technology (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peiga Medical Technology (Suzhou) Co.

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kejing Yi

Role: CONTACT

yikejing@peijiamedical.com

+86-13801858760

Facility Contacts

Kejing Yi

Role: primary

yikejing@peijiamedical.com

+86-13801858760

Other Identifiers

23CSP001

Identifier Type: -

Identifier Source: org_study_id