Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China

NCT05610566 | Recruiting

• 1 other identifier: 23CSP001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• All-cause mortality at 12 months

  All-cause mortality

  12 months

Secondary Outcomes (3)

• Technical success

  Immediate after procedure

• Cardiac function change

  30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years

• Quality of life of patients

  30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years

Other Outcomes (3)

• Operative complication

  Immediately after procedure

• The incidence of major adverse cardiovascular and cerebrovascular events during the trial(MACCEs)

  30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years

• Incidence of major adverse valve-related events (MAVREs) during the trial

  30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years

Study Arms (1)

A single set of test

EXPERIMENTAL

The HighLife Trans-Septal TMVR System comprises a 28mm Transcatheter Mitral Valve, a loop placement catheter, a sub-annular implant and its delivery systems.

Device: the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System

Interventions

the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System DEVICE

The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a subannular implant (SAI), and their delivery systems and accessories. The TMV is a 28mm mitral bioprosthesis made of a self-expanding Nitinol frame covered with polyester graft and supporting bovine pericardium leaflets. The bioprosthesis is used in conjunction with the Sub-Annular Implant (SAI), comprising a ring (made of polycarbonate urethane (PCU), nitinol, gold markers and polyester (Dacron) to be placed around the mitral valve apparatus to stabilize the position of the mitral valve implant.

A single set of test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Peijia Medical Technology (Suzhou) Co., Ltd.: lead
• West China Hospital: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator

Study Sites (1)

Peiga Medical Technology (Suzhou) Co.

Suzhou, Jiangsu, 215025, China

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Kejing Yi

CONTACT

+86-13801858760; yikejing@peijiamedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 9, 2022
• Study Start: July 6, 2022
• Primary Completion: July 6, 2025
• Study Completion (Estimated): July 6, 2029
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

CN (1)