NCT05610566RecruitingNot Applicable
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
Peijia Medical Technology (Suzhou) Co., Ltd.1 site in 1 country110 target enrollmentStarted: July 6, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- All-cause mortality at 12 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who voluntarily participate and sign the informed consent form and can cooperate with the completion of the entire trial process;
- •Age ≥ 18 years old;
- •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.
- •Patients with New York Heart Association (NYHA) functional ratings are Class II, III, or ambulatory Class IV;
- •Anatomically appropriate for treatment with the HighLife Transcatheter Mitral Valve Replacement System.
Exclusion Criteria
- •Patients had any stroke/TIA within 30 days;
- •Patients with severe symptomatic bilateral carotid stenosis (>70% stenosis on non-invasive imaging);
- •Patients with active infection requiring antibiotic therapy;
- •Patients with active ulcer or gastrointestinal bleeding within the past 3 months;
- •Patients with history of coagulopathy or refuse future blood transfusion;
- •Patients unable to undergo transesophageal echocardiography (TEE);
- •Patients who are pregnant or breastfeeding, or planning to have children within 12 months;
- •Patients who are unable to adhere to the follow-up schedule and complete the examination;
- •Patients enrolled in other clinical studies and within the follow-up period;
- •Patients with known allergies to device components or contrast agents;
- •Patients unable to receive anticoagulant or antiplatelet therapy;
- •Patients with a life expectancy of less than 12 months due to non-cardiac disease;
- •Patients requiring emergency surgical treatment;
- •Patients scheduled for cardiac surgery within 12 months;
- •Patients with an inappropriate mitral annulus or leaflet size (<30 mm and >45 mm);
- •Patients with moderate or above mitral stenosis;
- •Flail mitral leaflets, or moderate to severe mitral valve prolapse;
- •Patients with severe hepatic or renal insufficiency;
- •Patients with severe calcification of the mitral annulus and/or mitral leaflets;
- •Patients with history of mitral valve surgery or interventional therapy, or left atrial appendage occlusion device;
- •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;
- •Patients with untreated symptomatic coronary lesions requiring revascularization;
- •Patients with untreated severe aortic stenosis and severe aortic regurgitation;
- •Patients with aortic valve prosthesis;
- •Patients with severe tricuspid valve lesions requiring surgical intervention;
- •Patients with significant right ventricular dysfunction (such as biliteral lower extremities edema with increased jugular vein pulsation and hepatomegaly;
- •LVEF < 30%; LVEDD > 70 mm;
- •Patients with echocardiographically confirmed intracardiac mass, thrombus or neoplasm;
- •Hypertrophic obstructive cardiomyopathy (HOCM);
- •Patients with active or recent (within 3 months) endocarditis;
- •Patients with definite non-left heart disease induced severe pulmonary hypertension (echocardiographic indication: systolic pulmonary artery pressure (SPAP) > 70 mmHg)
- •Patients with hypotension (systolic blood pressure <90 mmHg) occurring within 7 days or mechanical hemodynamic support.
Outcomes
Primary Outcomes
All-cause mortality at 12 months
Time Frame: 12 months
All-cause mortality
Secondary Outcomes
- Cardiac function change(30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years)
- Technical success(Immediate after procedure)
- Quality of life of patients(30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years)
Investigators
Study Sites (1)
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