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Clinical Trials/NCT05610566
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

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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