Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-01-01 @ 12:32 AM
Study NCT ID:
NCT07021612
Status:
RECRUITING
Last Update Posted:
2025-06-15
First Post:
2025-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Patients With Pure Aortic Regurgitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2025-06-13', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of leaflet thrombosis', 'timeFrame': '6 month', 'description': 'Presence of hypoattenuated leaflet thickening (HALT) detected on 6 month follow-up computed tomography'}, {'measure': 'Presence of leaflet thrombosis', 'timeFrame': '6 month', 'description': 'Presence of restricted leaflet motion (RELM) detected on 6 month follow-up computed tomography'}, {'measure': 'Presence of leaflet thrombosis', 'timeFrame': '6 month', 'description': 'Presence of hypoattenuation affecting motion (HAM) detected on 6 month follow-up computed tomography'}], 'secondaryOutcomes': [{'measure': 'Magnetic Resonance Imaging (MRI)', 'timeFrame': '1 month', 'description': 'Comparison of 4D-Flow pattern using MRI at 1 month post-OP vs pre-OP'}, {'measure': 'Magnetic Resonance Imaging (MRI)', 'timeFrame': '1 month', 'description': 'Comparison of Aortic Valve Flow Velocity using MRI at 1 month post-OP vs pre-OP'}, {'measure': 'Magnetic Resonance Imaging (MRI)', 'timeFrame': '1 month', 'description': 'Comparison of Aortic Wall shear stress using MRI at 1 month post-OP vs pre-OP'}, {'measure': 'Magnetic Resonance Imaging (MRI)', 'timeFrame': '1 month', 'description': 'Comparison of Intraventricular flow pattern using MRI at 1 month post-OP vs pre-OP'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': 'Baseline', 'description': 'Presence of leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on CT images at baseline'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': 'Up to 1-month post-OP', 'description': 'Presence of leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on CT images at post-OP'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': '1-year', 'description': 'Presence of leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on CT images at 1 year post-OP'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': 'Baseline', 'description': 'Presence of leaflet thrombosis (restricted leaflet motion (RELM)) on CT images at baseline'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': 'Up to 1-month post-OP', 'description': 'Presence of leaflet thrombosis (restricted leaflet motion (RELM)) on CT images at post-OP'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': '1-year', 'description': 'Presence of leaflet thrombosis (restricted leaflet motion (RELM)) on CT images at 1 year post-OP'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': 'Baseline', 'description': 'Presence of leaflet thrombosis (hypoattenuation affecting motion (HAM )on CT images at baseline'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': 'Upto 1-month post-OP', 'description': 'Presence of leaflet thrombosis (hypoattenuation affecting motion (HAM )on CT images at post-OP'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': '1-year', 'description': 'Presence of leaflet thrombosis (hypoattenuation affecting motion (HAM )on CT images at 1 year post-OP'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': 'Baseline', 'description': 'To obtain the native valve dimensions using CT imaging at pre-OP (baseline)'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': 'Up to 1-month post-OP', 'description': 'To compare the impanted Transcatheter valve dimensions using CT imaging with baseline at post-OP'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': '6-month', 'description': 'To compare the impanted Transcatheter valve dimensions using CT imaging with baseline at 6 month post-OP'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': '1-year', 'description': 'To compare the impanted Transcatheter valve dimensions using CT imaging with baseline at 12 month post-OP'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': 'Up to 1-month post-OP', 'description': 'To obtain the impanted Transcatheter valve location using CT imaging at post-OP'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': '6-month', 'description': 'To compare the impanted Transcatheter valve location using CT imaging with post-OP at 6 month post-OP'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': '1-year', 'description': 'To compare the impanted Transcatheter valve location using CT imaging with post-OP at 12 month post-OP'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': 'Baseline', 'description': 'To obtain the native valve leaflet overhang using CT imaging at pre-OP (baseline)'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': 'Up to 1-month post-OP', 'description': 'To obtain the impanted valve leaflet overhang using CT imaging at post-OP'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': '6-month', 'description': 'To compare the impanted valve leaflet overhang using CT imaging with post-OP at 6 month post-OP'}, {'measure': 'Computed Tomographic Endpoints', 'timeFrame': '1-year', 'description': 'To compare the impanted valve leaflet overhang using CT imaging with post-OP at 12 month post-OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': 'Baseline', 'description': 'To grade AR Severity using echocardiography at baseline ii. Mean Aortic valve pressure gradient iii. Left Ventricular Ejection Fraction (LVEF) iv. Paravalvular leak severity'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': 'day 1-7', 'description': 'To grade AR Severity using echocardiography at Day 1-7 post-OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': 'day 30', 'description': 'To grade AR Severity using echocardiography at Day30 post-OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': '6-month', 'description': 'To grade AR Severity using echocardiography at 6 months post-OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': '1-year', 'description': 'To grade AR Severity using echocardiography at 1 year post-OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': 'Baseline', 'description': 'To obtain Mean Aortic valve pressure gradient using echocardiography at baseline'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': 'day 1-7', 'description': 'To obtain Mean Aortic valve pressure gradient using echocardiography at Day 1-7 post OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': 'day 30', 'description': 'To obtain Mean Aortic valve pressure gradient using echocardiography at Day 30 post OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': '6-month', 'description': 'To obtain Mean Aortic valve pressure gradient using echocardiography at 6 months post OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': '1-year', 'description': 'To obtain Mean Aortic valve pressure gradient using echocardiography at 12 months post OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': 'Baseline', 'description': 'To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at baseline'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': 'Day 1-7 post OP', 'description': 'To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at Day 1-7 post OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': 'Day30 post OP', 'description': 'To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at Day 30 post OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': '6 months post OP', 'description': 'To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at 6 months post OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': '12 months post OP', 'description': 'To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at 12 months post OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': 'Day 1-7 post OP', 'description': 'To evaluate Paravalvular leak severity using echocardiography at Day 1-7 post OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': 'Day 30 post OP', 'description': 'To evaluate Paravalvular leak severity using echocardiography at Day 30 post OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': '6 months post OP', 'description': 'To evaluate Paravalvular leak severity using echocardiography at 6 months post OP'}, {'measure': 'Echocardiographic Endpoints', 'timeFrame': '12 months post OP', 'description': 'To evaluate Paravalvular leak severity using echocardiography at 12 months post OP'}, {'measure': 'cardiovascular Mortality events', 'timeFrame': '12 months post OP', 'description': 'cardiovascular Mortality event up till 12 months post-OP'}, {'measure': 'Myocardial Infarction event', 'timeFrame': '12 months post OP', 'description': 'Myocardial Infarction (MI) event up till 12 months post-OP'}, {'measure': 'Stroke event', 'timeFrame': '12 months post OP', 'description': 'Stroke event up till 12 months post-OP'}, {'measure': 'New onset renal failure event', 'timeFrame': '12 months post OP', 'description': 'New onset renal failure requiring unplanned dialysis or renal replacement therapyevent up till 12 months post-OP'}, {'measure': 'Severe Bleeding event', 'timeFrame': '12 months post OP', 'description': 'Severe Bleeding (includes fatal, life-threatening and extensive bleeding as defined by VARC) event up till 12 months post-OP'}, {'measure': 'Non-elective aortic valve surgery event', 'timeFrame': '12 months post OP', 'description': 'Non-elective aortic valve surgery event up till 12 months post-OP'}, {'measure': 'Non-elective transcatheter re-intervention event', 'timeFrame': '12 months post OP', 'description': 'Non-elective transcatheter re-intervention post procedure event up till 12 months post-OP'}, {'measure': 'Major cardiac structural complications', 'timeFrame': '12 months post OP', 'description': 'Major cardiac structural complications event up till 12 months post-OP'}, {'measure': 'Major access site complications', 'timeFrame': '12 months post OP', 'description': 'Major access site complications event up till 12 months post-OP'}, {'measure': 'New pacemaker implantation event', 'timeFrame': '12 months post OP', 'description': 'New pacemaker implantation due to AV block event up till 12 months post-OP'}, {'measure': 'Acute Device Success Rate', 'timeFrame': 'immediately post-OP', 'description': 'Rate of successful deployment of the device and removal of the delivery system as planned, with no unplanned surgery related to the device or access procedure immediately post-OP'}, {'measure': 'Procedural Success Rate', 'timeFrame': 'immediately post-OP', 'description': 'Rate of Device success without clinically significant PVL, as determined by the Echo Core Lab (ECL) assessment of a discharge TTE. Subjects who die or undergo aortic valve surgery before discharge are procedure failures.'}, {'measure': 'All-cause mortality', 'timeFrame': '30-day', 'description': '30-day all-cause mortality rate of subjects'}, {'measure': 'All-cause mortality', 'timeFrame': '1-year', 'description': '1-year all-cause mortality rate of subjects'}, {'measure': 'heart failure hospitalization', 'timeFrame': '30-day', 'description': '30-day heart failure hospitalization rate of subjects'}, {'measure': 'heart failure hospitalization', 'timeFrame': '1-year', 'description': '1 year heart failure hospitalization rate of subjects'}, {'measure': 'NYHA Functional Class', 'timeFrame': 'Baseline', 'description': 'NYHA Functional Class of subjects at baseline'}, {'measure': 'NYHA Functional Class', 'timeFrame': 'Post-OP', 'description': 'NYHA Functional Class of subjects at post-OP'}, {'measure': 'NYHA Functional Class', 'timeFrame': '1 month Post-OP', 'description': 'NYHA Functional Class of subjects at 1 month post-OP'}, {'measure': 'NYHA Functional Class', 'timeFrame': '6-month Post-OP', 'description': 'NYHA Functional Class of subjects at 6-month post-OP'}, {'measure': 'NYHA Functional Class', 'timeFrame': '12-month Post-OP', 'description': 'NYHA Functional Class of subjects at 12-month post-OP'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Transcatherter Aortic Valve Intervention'], 'conditions': ['Aortic Valve Disease']}, 'descriptionModule': {'briefSummary': 'Aortic regurgitation (AR) is not uncommon. Transcatheter aortic valve implantation (TAVI) for treating pure aortic regurgitation is a potential future treatment option for pure AR especially in patients having high risk for open heart surgery.\n\nTAVI using dedicated device for pure AR has a different anchor mechanism to TAVI for aortic stenosis (AS). AR patientsalso have different cardiac flow pattern, aortic root pathology and left ventricular remodeling pattern compared to AS patients. Subclinical leaflet thrombosis has been described in AS patient receiving TAVI, which will affect the durability and antithrombotic regime. Follow-up imaging for dedicated TAVI device in AR patient is limited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH\n2. with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy\n3. Deemed high risk for aortic valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists)\n4. Capable of providing informed consent\n\nExclusion Criteria:\n\n1. Evidence of intracardiac mass, thrombus or vegetation\n2. Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT\n3. Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure\n4. Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.\n5. Chronic Kidney Disease with eGFR \\<30 ml/min/1.73m2.\n6. Cardiogenic shock or other hemodynamic instability requiring inotropic support or ventricular assist device\n7. Contraindicated for CT or MRI assessment'}, 'identificationModule': {'nctId': 'NCT07021612', 'acronym': 'CAIR-JAR', 'briefTitle': 'A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Patients With Pure Aortic Regurgitation', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Wales Hospital, Shatin, Hong Kong'}, 'officialTitle': 'A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Patients With Pure Aortic Regurgitation: An Observational Study', 'orgStudyIdInfo': {'id': '2025.079'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Interventional group', 'description': 'Patient implanted with J-Valve or JenaValve TAVI system', 'interventionNames': ['Device: JenaValve', 'Device: J-Valve']}], 'interventions': [{'name': 'JenaValve', 'type': 'DEVICE', 'description': 'JenaValve is a newly developed advanced TAVI system developed by Jenavalve Technology Inc.', 'armGroupLabels': ['Interventional group']}, {'name': 'J-Valve', 'type': 'DEVICE', 'description': 'J-Valve is a newly developed advanced TAVI system developed by Genesis Medtech.', 'armGroupLabels': ['Interventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Hong Kong', 'state': 'Shatin', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Chak Yu So', 'role': 'CONTACT', 'email': 'kentso987@gmail.com', 'phone': '85260338536'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Wales Hospital, Shatin, Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Dr So Chak Yu kent', 'investigatorAffiliation': 'Prince of Wales Hospital, Shatin, Hong Kong'}}}}