Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-22 @ 4:36 AM
Study NCT ID:
NCT05864456
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 73}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2023-05-17', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite endpoint event rate at 30 days', 'timeFrame': '30 days after procedure', 'description': 'Composite endpoint event includes all-cause death, stroke, myocardial infarction, permanent pacemaker implantation, serious vascular and access-related complications, surgical intervention for aortic valve reoperation, valve-in-valve surgery.'}], 'secondaryOutcomes': [{'measure': 'Device success rate', 'timeFrame': 'Immediately after procedure', 'description': 'Device success is defined as\n\n1. The device enters the vascular approach, be transported, released and implanted successfully, and the delivery system is removed from the body successfully;\n2. The implanted valve achieves the desired efficacy (mean transvalvular pressure difference \\<20 mmHg or peak flow velocity \\<3 m/s in the aortic valve, no severe prosthetic aortic regurgitation or perivalvular leak).'}, {'measure': 'Procedural success rate', 'timeFrame': 'Immediately after procedure', 'description': 'Procedure success is defined as\n\n1. Implantation of ≤2 valves, with the implanted valves placed in the appropriate anatomic position;\n2. No intraoperative or immediate postoperative mortality;\n3. The intended purpose of the procedure was achieved without serious intraoperative complications (coronary occlusion, septal perforation, mitral valve damage or incompetence, pericardial tamponade, surgical termination, and open-heart surgical treatment for cardiac surgery).'}, {'measure': 'Delivery system and component performance evaluation', 'timeFrame': 'Immediately after procedure', 'description': 'Delivery system performance evaluation includes delivery, transvalve, release positioning, balloon filling and retrieval, visibility, and retrieval performance.\n\n(For each assessment: 1-4 points；1=excellent, 2=good, 3=fair, 4=poor).'}, {'measure': 'Valve function', 'timeFrame': 'Immediately after procedure, 1 day of discharge, 30 days, 1 year', 'description': 'Valve function includes aortic orifice area, transvalvular pressure difference, valvular regurgitation, and perivalvular leakage.'}, {'measure': 'Improvement in cardiac function', 'timeFrame': '1 day of discharge, 30 days, 1-5 year', 'description': 'Cardiac function is based on the New York Heart Association (NYHA) classification scheme.'}, {'measure': 'Improvement in quality of life', 'timeFrame': '30 days, 1 year', 'description': 'The SF-12 rating scale is used to assess quality of life.'}, {'measure': 'Incidence of all-cause mortality', 'timeFrame': 'Immediately after procedure, 1 day of discharge, 30 days, 1-5 year', 'description': 'Rate of all-cause mortality during the trial. All-cause mortality includes cardiovascular morality and non-cardiovascular morality.'}, {'measure': 'Incidence of myocardial infarction', 'timeFrame': 'Immediately after procedure, 1 day of discharge, 30 days, 1-5 year', 'description': 'Rate of patients with myocardial infarction during the trial.'}, {'measure': 'Incidence of disabling stroke', 'timeFrame': '1 day of discharge, 30 days, 1-5 year', 'description': 'Rate of patients with disabling stroke during the trial.'}, {'measure': 'Incidence of permanent pacemaker implantation', 'timeFrame': '1 day of discharge, 30 days, 1-5 year', 'description': 'Rate of patients with permanent pacemaker implantation during the trial.'}, {'measure': 'Incidence of serious vascular and access-related complications', 'timeFrame': 'Immediately after procedure, 1 day of discharge, 30 days, 1-5 year', 'description': 'Rate of patients with serious vascular and access-related complications during the trial.'}, {'measure': 'Incidence of serious bleeding', 'timeFrame': '1 day of discharge, 30 days, 1-5 year', 'description': 'Rate of patients with serious bleeding during the trial.'}, {'measure': 'Incidence of acute kidney injury', 'timeFrame': '1 day of discharge, 30 days, 1-5 year', 'description': 'Rate of patients with acute kidney injury during the trial.'}, {'measure': 'Incidence of major cardiovascular and cerebrovascular adverse events', 'timeFrame': '1 day of discharge, 30 days, 1-5 year', 'description': 'Incidence of MACCE during the trial. MACCE is defined as death, stroke, myocardial infarction, arrhythmia, conduction block, and aortic valve reoperation (interventional or surgical).'}, {'measure': 'Incidence of other TAVI-related complications', 'timeFrame': 'Immediately after procedure, 1 day of discharge, 30 days, 1-5 year', 'description': 'Rate of patients with other TAVI-related complications during the trial. Other TAVI-related complications include conversion to surgery, valve-in-valve implantation, accidental cardiopulmonary mechanical assistance, coronary occlusion, ventricular septal perforation, mitral valve damage or loss of function, pericardial tamponade, endocarditis, valvular thrombosis, valvular ectopic (migration, embolization, erroneous release), etc.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.', 'detailedDescription': 'This study is a multicenter, single-arm, prospective clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 65 years ;\n2. Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m/s, or aortic Valve area\\<1.0cm², or AVA \\<0.5cm² /m²);\n3. Cardiac function NYHA ≥ II;\n4. Life expectancy\\> 12 months;\n5. Patients who are anatomically suitable for transcatheter aortic valve implantation;\n6. Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery;\n7. Patients who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.\n\nExclusion Criteria:\n\n1. Acute myocardial infarction occurred within 1 month before this treatment;\n2. Congenital unicuspid aortic valve;\n3. Any therapeutic cardiac operation that is performed within 30 days of the index procedure (Previous PCI or implantation of a permanent pacemaker are not considered exclusion criteria);\n4. Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (\\>3+);\n5. Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate;\n6. Untreated severe coronary artery stenosis that requires revascularization;\n7. Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;\n8. Patients who need emergency surgery for any reason;\n9. Patients with hypertrophic cardiomyopathy with obstruction;\n10. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \\<20%;\n11. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;\n12. Patients with left ventricular outflow tract obstruction;\n13. A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;\n14. Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components;\n15. Patients who are unable to receive anticoagulation or antiplatelet therapy;\n16. Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;\n17. Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc;\n18. Active infective endocarditis or other active infections;\n19. Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not yet reached the primary outcome of research;\n20. The investigator judged that patient with poor compliance and could not complete the study as required.'}, 'identificationModule': {'nctId': 'NCT05864456', 'briefTitle': 'Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai NewMed Medical Co., Ltd.'}, 'officialTitle': 'Evaluation of the Safety and Efficacy of the Prizvalve Pro™ Transcatheter Aortic Valve System in the Treatment of Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk', 'orgStudyIdInfo': {'id': 'Prizvalve Pro-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcatheter aortic valve replacement', 'description': 'Transcatheter aortic valve replacement with Prizvalve Pro™ transcatheter aortic valve system', 'interventionNames': ['Device: Prizvalve Pro™ transcatheter aortic valve system']}], 'interventions': [{'name': 'Prizvalve Pro™ transcatheter aortic valve system', 'type': 'DEVICE', 'description': 'Transcatheter Aortic Valve Replacement', 'armGroupLabels': ['Transcatheter aortic valve replacement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuyang Xie', 'role': 'CONTACT'}], 'facility': 'Shanghai NewMed Medical Co., Ltd.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Chunyang Wang', 'role': 'CONTACT', 'email': 'wang_chunyang@newmed.cn', 'phone': '(86)-21-20788668'}, {'name': 'Xuyang Xie', 'role': 'CONTACT', 'phone': '(86)-21-20788668'}], 'overallOfficials': [{'name': 'Yaling Han, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Principal coordinating investigator'}, {'name': 'Mao Chen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'coordinating investigator'}, {'name': 'Kai Xu, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'coordinating investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai NewMed Medical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The General Hospital of Northern Theater Command', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}