Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-29 @ 8:43 PM
Study NCT ID:
NCT07122050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prizvalve Transcatheter Aortic Valve in Failing Bioprosthetic Valves
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-10', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-08-10', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'At 30 days', 'description': 'The primary end point is the 30 days all-cause mortality'}], 'secondaryOutcomes': [{'measure': 'Device success', 'timeFrame': 'immediate post-surgical', 'description': 'Device Success Criteria\n\n1. Successful vascular access, delivery, deployment and implantation of the study device, with complete removal of the delivery system from the body;\n2. The implanted prosthetic valve achieves the intended haemodynamic performance, defined as the absence of moderate or greater prosthetic valve stenosis or regurgitation.'}, {'measure': 'Procedural success', 'timeFrame': 'immediate post-surgical', 'description': 'Procedural Success Criteria\n\n1. Correct anatomical positioning of the implanted valve;\n2. No intra-operative or immediate post-procedural death (≤ 72 h);\n3. Achievement of the intended therapeutic goal without occurrence of any major intra-operative complication, including but not limited to coronary obstruction, ventricular septal perforation, damage or dysfunction of other native valves, cardiac tamponade, procedure termination, or conversion to open cardiac surgery.'}, {'measure': 'All-cause mortality', 'timeFrame': 'At 6 months, 1 year'}, {'measure': 'The incidence of rehospitalization', 'timeFrame': 'At 30 days, 6 months, 1 year'}, {'measure': 'The incidence of myocardial infarction', 'timeFrame': 'At 30 days, 6 months, 1 year'}, {'measure': 'The incidence of stroke', 'timeFrame': 'At 30 days, 6 months, 1 year'}, {'measure': 'The incidence of bleeding', 'timeFrame': 'At 30 days, 6 months, 1 year'}, {'measure': 'The incidence of acute kidney injury', 'timeFrame': 'At 30 days, 6 months, 1 year'}, {'measure': 'The incidence of permanent pacemaker implantation', 'timeFrame': 'At 30 days, 6 months, 1 year'}, {'measure': 'The incidence of vascular and access-related complications', 'timeFrame': 'At 30 days, 6 months, 1 year'}, {'measure': 'The incidence of procedure-related complications', 'timeFrame': 'At 30 days, 6 months, 1 year'}, {'measure': 'The incidence of valve dysfunction', 'timeFrame': 'At 30 days, 6 months, 1 year'}, {'measure': 'The incidence of NYHA functional class improvement', 'timeFrame': 'At 30 days, 6 months, 1 year', 'description': 'the New York Heart Association to quantify the severity of functional limitation and symptoms attributable to cardiac disease'}, {'measure': 'The incidence of quality-of-life improvement', 'timeFrame': 'At 30 days, 6 months, 1 year', 'description': 'By SF-12 Health Survey (Short-Form 12-item Health Survey)'}, {'measure': 'The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)', 'timeFrame': 'At 30 days, 6 months, 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prizvalve Valve in Valve'], 'conditions': ['Failing Bioprosthetic Valves']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and effectiveness of the Prizvalve transcatheter aortic valve in subjects who are at high or greater risk with failing bioprosthetic valves.', 'detailedDescription': 'Prospective, single arm, multicenter study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to be eligible for participation:\n\n1. Age≥18 years old;\n2. Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);\n3. NYHA Function Class≥ II;\n4. Patient who is anatomically suitable for the implantation of the Prizvalve®;\n5. According to heart team , patient is at high or greater surgical risk or not suitable for redo open heart surgery of valve replacement;\n6. Patient understands the purpose of the trial and volunteers to participate in, sign the informed consent form and is willing to accept relevant examinations and clinical follow-ups.\n\nExclusion Criteria:\n\n1. Moderate or greater paravalvular regurgitation of the degenerated bioprosthetic valve；\n2. Degenerated valve that cannot be securely fixed within the native annulus or exhibits structural incompleteness；\n3. Anatomical features deemed unsuitable for transcatheter implantation.\n4. Anatomical features that significantly increase the risk of left ventricular outflow tract (LVOT) obstruction；\n5. Acute myocardial infarction within 30 days prior to enrollment；\n6. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation；\n7. Active infective endocarditis or any other active infection；\n8. Severe right ventricular dysfunction or severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \\< 20 %；\n9. Inability to tolerate anticoagulant or antiplatelet therapy；\n10. Cerebrovascular accident within 3 months prior to enrollment, excluding transient ischemic attack；\n11. Refusal to undergo emergency cardiac surgery under any circumstances；\n12. Participation in another drug or device clinical trial that has not yet reached its primary endpoint as of the time of enrollment；\n13. Investigator-assessed poor compliance that would preclude adherence to protocol requirements；'}, 'identificationModule': {'nctId': 'NCT07122050', 'briefTitle': 'Prizvalve Transcatheter Aortic Valve in Failing Bioprosthetic Valves', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Safety and Effectiveness of Prizvalve Transcatheter Aortic Valve in Patients With Failing Bioprosthetic Valves', 'orgStudyIdInfo': {'id': 'Prizvalve-VIV-202504'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '105 Failing Mitral Bioprosthetic Valve', 'interventionNames': ['Device: Prizvalve® system Transcatheter valve-in-valve replacement']}, {'type': 'EXPERIMENTAL', 'label': 'At Least 10 Failing Tricuspid Bioprosthetic Valve', 'interventionNames': ['Device: Prizvalve® system Transcatheter valve-in-valve replacement']}, {'type': 'EXPERIMENTAL', 'label': 'At Least 10 Failing Aortic Bioprosthetic Valve', 'interventionNames': ['Device: Prizvalve® system Transcatheter valve-in-valve replacement']}], 'interventions': [{'name': 'Prizvalve® system Transcatheter valve-in-valve replacement', 'type': 'DEVICE', 'description': 'Transcatheter valve-in-valve replacement procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted.', 'armGroupLabels': ['105 Failing Mitral Bioprosthetic Valve', 'At Least 10 Failing Aortic Bioprosthetic Valve', 'At Least 10 Failing Tricuspid Bioprosthetic Valve']}]}, 'contactsLocationsModule': {'locations': [{'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'contacts': [{'name': 'Jian Yang, MD, PhD', 'role': 'CONTACT', 'email': 'yangjian@fmmu.edu.cn', 'phone': '+8613892828016'}, {'name': 'Meng en Zhai, PhD', 'role': 'CONTACT', 'email': 'zhaimengen@126.com', 'phone': '+8617782801836'}], 'facility': 'Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Jian Yang, MD, PhD', 'role': 'CONTACT', 'email': 'yangjian@fmmu.edu.cn', 'phone': '+8613892828016'}, {'name': 'Meng en Zhai, PhD', 'role': 'CONTACT', 'email': 'zhaimengen@126.com', 'phone': '+8617782801836'}], 'overallOfficials': [{'name': 'Jian Yang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) would not be shared, according to local authority data privacy policy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}