Evaluating a new device for treating severe mitral regurgitation in patients in China

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

This study is testing a new device to see if it can safely help adults with severe mitral regurgitation who are at high risk for surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peijia Medical Technology (Suzhou) Co., Ltd. (industry)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05610566 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of the HighLife Transcatheter Mitral Valve Replacement System in patients suffering from moderate-severe or severe mitral regurgitation. It will be conducted as a prospective, multicenter trial, utilizing objective performance criteria to evaluate outcomes. Eligible participants will include adults aged 18 and older who have been diagnosed with significant mitral regurgitation and have undergone appropriate medical therapy. The study will focus on patients who are at high surgical risk and require intervention.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with moderate-severe or severe mitral regurgitation who are at high risk for surgical intervention.

Not a fit: Patients with mild mitral regurgitation or those who do not meet the inclusion criteria, such as those with low surgical risk, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with severe mitral regurgitation, potentially improving their quality of life and clinical outcomes.

How similar studies have performed: Other studies have shown promise with transcatheter approaches for mitral valve replacement, indicating a growing body of evidence supporting this innovative treatment method.

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.

Where this trial is running

Suzhou, Jiangsu

• Peiga Medical Technology (Suzhou) Co. — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Kejing Yi

Conditions: Mitral Regurgitation