NCT05610566 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peijia Medical Technology (Suzhou) Co., Ltd. |
| Condition | Mitral Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2022-07-06 |
| Primary Completion | 2025-07-06 |
Trial Parameters
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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.
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,