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

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

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 Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kejing Yi; Phone Number: +86-13801858760; Email: yikejing@peijiamedical.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215025
      • Recruiting
      • Peiga Medical Technology (Suzhou) Co.
      • Contact: Kejing Yi; Phone Number: +86-13801858760; Email: yikejing@peijiamedical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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, or ambulatory Class IV;
5. Anatomically appropriate for treatment with the HighLife Transcatheter Mitral Valve Replacement System.

Exclusion Criteria:

1. Patients had any stroke/TIA within 30 days;
2. Patients with severe symptomatic bilateral carotid stenosis (>70% stenosis on non-invasive imaging);
3. Patients with active infection requiring antibiotic therapy;
4. Patients with active ulcer or gastrointestinal bleeding within the past 3 months;
5. Patients with history of coagulopathy or refuse future blood transfusion;
6. Patients unable to undergo transesophageal echocardiography (TEE);
7. Patients who are pregnant or breastfeeding, or planning to have children within 12 months;
8. Patients who are unable to adhere to the follow-up schedule and complete the examination;
9. Patients enrolled in other clinical studies and within the follow-up period;
10. Patients with known allergies to device components or contrast agents;
11. Patients unable to receive anticoagulant or antiplatelet therapy;
12. Patients with a life expectancy of less than 12 months due to non-cardiac disease;
13. Patients requiring emergency surgical treatment;
14. Patients scheduled for cardiac surgery within 12 months;
15. Patients with an inappropriate mitral annulus or leaflet size (<30 mm and >45 mm);
16. Patients with moderate or above mitral stenosis;
17. Flail mitral leaflets, or moderate to severe mitral valve prolapse;
18. Patients with severe hepatic or renal insufficiency;
19. Patients with severe calcification of the mitral annulus and/or mitral leaflets;
20. Patients with history of mitral valve surgery or interventional therapy, or left atrial appendage occlusion device;
21. 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;
22. Patients with untreated symptomatic coronary lesions requiring revascularization;
23. Patients with untreated severe aortic stenosis and severe aortic regurgitation;
24. Patients with aortic valve prosthesis;
25. Patients with severe tricuspid valve lesions requiring surgical intervention;
26. Patients with significant right ventricular dysfunction (such as biliteral lower extremities edema with increased jugular vein pulsation and hepatomegaly;
27. LVEF < 30%; LVEDD > 70 mm;
28. Patients with echocardiographically confirmed intracardiac mass, thrombus or neoplasm;
29. Hypertrophic obstructive cardiomyopathy (HOCM);
30. Patients with active or recent (within 3 months) endocarditis;
31. Patients with definite non-left heart disease induced severe pulmonary hypertension (echocardiographic indication: systolic pulmonary artery pressure (SPAP) > 70 mmHg)
32. Patients with hypotension (systolic blood pressure <90 mmHg) occurring within 7 days or mechanical hemodynamic support.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: A single set of test; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality at 12 months	All-cause mortality	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Technical success defined as an alive patient at exit from procedure room, with all of the following: Successful vascular access, delivery and retrieval of the HighLife delivery systems; Deployment and correct positioning of the HighLife 28mm bioprosthesis; Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE.	Immediate after procedure
Cardiac function change	NYHA functional classification	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Quality of life of patients	Quality of Life of patients accessed by EuroQol-5 Dimensions (EQ-5D) Questionnaire. The higher scores mean a worse health state. Recording changes from baseline.	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative complication	The rate of operative complication	Immediately after procedure
The incidence of major adverse cardiovascular and cerebrovascular events during the trial(MACCEs)	Incidence of MACCEs (mortality, stroke, myocardial infarction, and so on surgery, arrhythmias, conduction blocks) during the trial	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	including prosthetic valve-related death, permanent cardiac pacemaker implantation, permanent cardiac defibrillator implantation, prosthetic valve embolism, prosthetic valve thrombosis, prosthetic valve dysfunction.	30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2022
• Primary Completion (Anticipated): July 6, 2025
• Study Completion (Anticipated): July 6, 2029

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 23CSP001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No