Mitral Regurgitation Clinical Trial
Official title:
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
NCT number | NCT05610566 |
Other study ID # | 23CSP001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 6, 2022 |
Est. completion date | July 6, 2029 |
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.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | July 6, 2029 |
Est. primary completion date | July 6, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Peiga Medical Technology (Suzhou) Co. | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Peijia Medical Technology (Suzhou) Co., Ltd. | Second Affiliated Hospital, School of Medicine, Zhejiang University, The Second Affiliated Hospital of Harbin Medical University, West China Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Operative complication | The rate of operative complication | Immediately after procedure | |
Other | 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 | |
Other | 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 | |
Primary | All-cause mortality at 12 months | All-cause mortality | 12 months | |
Secondary | 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 | |
Secondary | Cardiac function change | NYHA functional classification | 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years | |
Secondary | 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 |
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