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 enrollmentJuly 6, 2022

ConditionsMitral Regurgitation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mitral Regurgitation
Sponsor: Peijia Medical Technology (Suzhou) Co., Ltd.
Enrollment: 110
Locations: 1
Primary Endpoint: All-cause mortality at 12 months
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

July 6, 2022

End Date

July 6, 2029

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peijia Medical Technology (Suzhou) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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;

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)