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

Not Applicable

Recruiting

• Conditions: Mitral Regurgitation
• Interventions: Device: the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System

• Registration Number: NCT05610566
• Lead Sponsor: Peijia Medical Technology (Suzhou) Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-06
• Status Verified: 2022-11
• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-07
• Last Update Submitted: 2022-11-07
• Study First Posted: 2022-11-09
• Last Update Posted: 2022-11-09
• Primary Completion: 2025-07-06
• Study Completion: 2029-07-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A single set of test	the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System	The HighLife Trans-Septal TMVR System comprises a 28mm Transcatheter Mitral Valve, a loop placement catheter, a sub-annular implant and its delivery systems.

Primary Outcome Measures

Name	Time	Method
All-cause mortality at 12 months	12 months	All-cause mortality

Secondary Outcome Measures

Name	Time	Method
Cardiac function change	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years	NYHA functional classification
Technical success	Immediate after procedure	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.
Quality of life of patients	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years	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.

Trial Locations

Locations (1)

Peiga Medical Technology (Suzhou) Co.; 🇨🇳 Suzhou, Jiangsu, China