Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT05610566
Status:
RECRUITING
Last Update Posted:
2022-11-09
First Post:
2022-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2029-07-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-07', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-07', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Operative complication', 'timeFrame': 'Immediately after procedure', 'description': 'The rate of operative complication'}, {'measure': 'The incidence of major adverse cardiovascular and cerebrovascular events during the trial(MACCEs)', 'timeFrame': '30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years', 'description': 'Incidence of MACCEs (mortality, stroke, myocardial infarction, and so on surgery, arrhythmias, conduction blocks) during the trial'}, {'measure': 'Incidence of major adverse valve-related events (MAVREs) during the trial', 'timeFrame': '30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years', 'description': 'including prosthetic valve-related death, permanent cardiac pacemaker implantation, permanent cardiac defibrillator implantation, prosthetic valve embolism, prosthetic valve thrombosis, prosthetic valve dysfunction.'}], 'primaryOutcomes': [{'measure': 'All-cause mortality at 12 months', 'timeFrame': '12 months', 'description': 'All-cause mortality'}], 'secondaryOutcomes': [{'measure': 'Technical success', 'timeFrame': 'Immediate after procedure', 'description': 'Technical success defined as an alive patient at exit from procedure room, with all of the following:\n\n* Successful vascular access, delivery and retrieval of the HighLife delivery systems\n* Deployment and correct positioning of the HighLife 28mm bioprosthesis\n* 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.'}, {'measure': 'Cardiac function change', 'timeFrame': '30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years', 'description': 'NYHA functional classification'}, {'measure': 'Quality of life of patients', 'timeFrame': '30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mitral Regurgitation']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who voluntarily participate and sign the informed consent form and can cooperate with the completion of the entire trial process;\n2. Age ≥ 18 years old;\n3. 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.\n\n 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.\n4. Patients with New York Heart Association (NYHA) functional ratings are Class II, III, or ambulatory Class IV;\n5. Anatomically appropriate for treatment with the HighLife Transcatheter Mitral Valve Replacement System.\n\nExclusion Criteria:\n\n1. Patients had any stroke/TIA within 30 days;\n2. Patients with severe symptomatic bilateral carotid stenosis (\\>70% stenosis on non-invasive imaging);\n3. Patients with active infection requiring antibiotic therapy;\n4. Patients with active ulcer or gastrointestinal bleeding within the past 3 months;\n5. Patients with history of coagulopathy or refuse future blood transfusion;\n6. Patients unable to undergo transesophageal echocardiography (TEE);\n7. Patients who are pregnant or breastfeeding, or planning to have children within 12 months;\n8. Patients who are unable to adhere to the follow-up schedule and complete the examination;\n9. Patients enrolled in other clinical studies and within the follow-up period;\n10. Patients with known allergies to device components or contrast agents;\n11. Patients unable to receive anticoagulant or antiplatelet therapy;\n12. Patients with a life expectancy of less than 12 months due to non-cardiac disease;\n13. Patients requiring emergency surgical treatment;\n14. Patients scheduled for cardiac surgery within 12 months;\n15. Patients with an inappropriate mitral annulus or leaflet size (\\<30 mm and \\>45 mm);\n16. Patients with moderate or above mitral stenosis;\n17. Flail mitral leaflets, or moderate to severe mitral valve prolapse;\n18. Patients with severe hepatic or renal insufficiency;\n19. Patients with severe calcification of the mitral annulus and/or mitral leaflets;\n20. Patients with history of mitral valve surgery or interventional therapy, or left atrial appendage occlusion device;\n21. 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;\n22. Patients with untreated symptomatic coronary lesions requiring revascularization;\n23. Patients with untreated severe aortic stenosis and severe aortic regurgitation;\n24. Patients with aortic valve prosthesis;\n25. Patients with severe tricuspid valve lesions requiring surgical intervention;\n26. Patients with significant right ventricular dysfunction (such as biliteral lower extremities edema with increased jugular vein pulsation and hepatomegaly;\n27. LVEF \\< 30%; LVEDD \\> 70 mm;\n28. Patients with echocardiographically confirmed intracardiac mass, thrombus or neoplasm;\n29. Hypertrophic obstructive cardiomyopathy (HOCM);\n30. Patients with active or recent (within 3 months) endocarditis;\n31. Patients with definite non-left heart disease induced severe pulmonary hypertension (echocardiographic indication: systolic pulmonary artery pressure (SPAP) \\> 70 mmHg)\n32. Patients with hypotension (systolic blood pressure \\<90 mmHg) occurring within 7 days or mechanical hemodynamic support.'}, 'identificationModule': {'nctId': 'NCT05610566', 'briefTitle': 'Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Peijia Medical Technology (Suzhou) Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '23CSP001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A single set of test', 'description': 'The HighLife Trans-Septal TMVR System comprises a 28mm Transcatheter Mitral Valve, a loop placement catheter, a sub-annular implant and its delivery systems.', 'interventionNames': ['Device: the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System']}], 'interventions': [{'name': 'the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['A single set of test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215025', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kejing Yi', 'role': 'CONTACT', 'email': 'yikejing@peijiamedical.com', 'phone': '+86-13801858760'}], 'facility': 'Peiga Medical Technology (Suzhou) Co.', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Kejing Yi', 'role': 'CONTACT', 'email': 'yikejing@peijiamedical.com', 'phone': '+86-13801858760'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peijia Medical Technology (Suzhou) Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'West China Hospital', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}