An observational study in Aortic Valve Disease, sponsored by Prince of Wales Hospital, Shatin, Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Prince of Wales Hospital, Shatin, Hong Kong · Observational
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.
TAVI 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.
234 studies on the registry are indexed under Aortic Valve Disease; 70 are open to participants now.
This study's planned enrollment of 30 is below the median of 200 across 106 observational studies indexed under Aortic Valve Disease.
Browse Aortic Valve Disease studies →Prince of Wales Hospital, Shatin, Hong Kong is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient implanted with J-Valve or JenaValve TAVI system
Device: JenaValve · Device: J-Valve
JenaValve is a newly developed advanced TAVI system developed by Jenavalve Technology Inc.
J-Valve is a newly developed advanced TAVI system developed by Genesis Medtech.
Presence of leaflet thrombosis
Presence of hypoattenuated leaflet thickening (HALT) detected on 6 month follow-up computed tomography
Time frame: 6 month
Presence of leaflet thrombosis
Presence of restricted leaflet motion (RELM) detected on 6 month follow-up computed tomography
Time frame: 6 month
Presence of leaflet thrombosis
Presence of hypoattenuation affecting motion (HAM) detected on 6 month follow-up computed tomography
Time frame: 6 month
Magnetic Resonance Imaging (MRI)
Comparison of 4D-Flow pattern using MRI at 1 month post-OP vs pre-OP
Time frame: 1 month
Magnetic Resonance Imaging (MRI)
Comparison of Aortic Valve Flow Velocity using MRI at 1 month post-OP vs pre-OP
Time frame: 1 month
Magnetic Resonance Imaging (MRI)
Comparison of Aortic Wall shear stress using MRI at 1 month post-OP vs pre-OP
Time frame: 1 month
Magnetic Resonance Imaging (MRI)
Comparison of Intraventricular flow pattern using MRI at 1 month post-OP vs pre-OP
Time frame: 1 month
Computed Tomographic Endpoints
Presence of leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on CT images at baseline
Time frame: Baseline
Computed Tomographic Endpoints
Presence of leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on CT images at post-OP
Time frame: Up to 1-month post-OP
Computed Tomographic Endpoints
Presence of leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on CT images at 1 year post-OP
Time frame: 1-year
Computed Tomographic Endpoints
Presence of leaflet thrombosis (restricted leaflet motion (RELM)) on CT images at baseline
Time frame: Baseline
Computed Tomographic Endpoints
Presence of leaflet thrombosis (restricted leaflet motion (RELM)) on CT images at post-OP
Time frame: Up to 1-month post-OP
Computed Tomographic Endpoints
Presence of leaflet thrombosis (restricted leaflet motion (RELM)) on CT images at 1 year post-OP
Time frame: 1-year
Computed Tomographic Endpoints
Presence of leaflet thrombosis (hypoattenuation affecting motion (HAM )on CT images at baseline
Time frame: Baseline
Computed Tomographic Endpoints
Presence of leaflet thrombosis (hypoattenuation affecting motion (HAM )on CT images at post-OP
Time frame: Upto 1-month post-OP
Computed Tomographic Endpoints
Presence of leaflet thrombosis (hypoattenuation affecting motion (HAM )on CT images at 1 year post-OP
Time frame: 1-year
Computed Tomographic Endpoints
To obtain the native valve dimensions using CT imaging at pre-OP (baseline)
Time frame: Baseline
Computed Tomographic Endpoints
To compare the impanted Transcatheter valve dimensions using CT imaging with baseline at post-OP
Time frame: Up to 1-month post-OP
Computed Tomographic Endpoints
To compare the impanted Transcatheter valve dimensions using CT imaging with baseline at 6 month post-OP
Time frame: 6-month
Computed Tomographic Endpoints
To compare the impanted Transcatheter valve dimensions using CT imaging with baseline at 12 month post-OP
Time frame: 1-year
Computed Tomographic Endpoints
To obtain the impanted Transcatheter valve location using CT imaging at post-OP
Time frame: Up to 1-month post-OP
Computed Tomographic Endpoints
To compare the impanted Transcatheter valve location using CT imaging with post-OP at 6 month post-OP
Time frame: 6-month
Computed Tomographic Endpoints
To compare the impanted Transcatheter valve location using CT imaging with post-OP at 12 month post-OP
Time frame: 1-year
Computed Tomographic Endpoints
To obtain the native valve leaflet overhang using CT imaging at pre-OP (baseline)
Time frame: Baseline
Computed Tomographic Endpoints
To obtain the impanted valve leaflet overhang using CT imaging at post-OP
Time frame: Up to 1-month post-OP
Computed Tomographic Endpoints
To compare the impanted valve leaflet overhang using CT imaging with post-OP at 6 month post-OP
Time frame: 6-month
Computed Tomographic Endpoints
To compare the impanted valve leaflet overhang using CT imaging with post-OP at 12 month post-OP
Time frame: 1-year
Echocardiographic Endpoints
To grade AR Severity using echocardiography at baseline ii. Mean Aortic valve pressure gradient iii. Left Ventricular Ejection Fraction (LVEF) iv. Paravalvular leak severity
Time frame: Baseline
Echocardiographic Endpoints
To grade AR Severity using echocardiography at Day 1-7 post-OP
Time frame: day 1-7
Echocardiographic Endpoints
To grade AR Severity using echocardiography at Day30 post-OP
Time frame: day 30
Echocardiographic Endpoints
To grade AR Severity using echocardiography at 6 months post-OP
Time frame: 6-month
Echocardiographic Endpoints
To grade AR Severity using echocardiography at 1 year post-OP
Time frame: 1-year
Echocardiographic Endpoints
To obtain Mean Aortic valve pressure gradient using echocardiography at baseline
Time frame: Baseline
Echocardiographic Endpoints
To obtain Mean Aortic valve pressure gradient using echocardiography at Day 1-7 post OP
Time frame: day 1-7
Echocardiographic Endpoints
To obtain Mean Aortic valve pressure gradient using echocardiography at Day 30 post OP
Time frame: day 30
Echocardiographic Endpoints
To obtain Mean Aortic valve pressure gradient using echocardiography at 6 months post OP
Time frame: 6-month
Echocardiographic Endpoints
To obtain Mean Aortic valve pressure gradient using echocardiography at 12 months post OP
Time frame: 1-year
Echocardiographic Endpoints
To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at baseline
Time frame: Baseline
Echocardiographic Endpoints
To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at Day 1-7 post OP
Time frame: Day 1-7 post OP
Echocardiographic Endpoints
To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at Day 30 post OP
Time frame: Day30 post OP
Echocardiographic Endpoints
To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at 6 months post OP
Time frame: 6 months post OP
Echocardiographic Endpoints
To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at 12 months post OP
Time frame: 12 months post OP
Echocardiographic Endpoints
To evaluate Paravalvular leak severity using echocardiography at Day 1-7 post OP
Time frame: Day 1-7 post OP
Echocardiographic Endpoints
To evaluate Paravalvular leak severity using echocardiography at Day 30 post OP
Time frame: Day 30 post OP
Echocardiographic Endpoints
To evaluate Paravalvular leak severity using echocardiography at 6 months post OP
Time frame: 6 months post OP
Echocardiographic Endpoints
To evaluate Paravalvular leak severity using echocardiography at 12 months post OP
Time frame: 12 months post OP
cardiovascular Mortality events
cardiovascular Mortality event up till 12 months post-OP
Time frame: 12 months post OP
Myocardial Infarction event
Myocardial Infarction (MI) event up till 12 months post-OP
Time frame: 12 months post OP
Stroke event
Stroke event up till 12 months post-OP
Time frame: 12 months post OP
New onset renal failure event
New onset renal failure requiring unplanned dialysis or renal replacement therapyevent up till 12 months post-OP
Time frame: 12 months post OP
Severe Bleeding event
Severe Bleeding (includes fatal, life-threatening and extensive bleeding as defined by VARC) event up till 12 months post-OP
Time frame: 12 months post OP
Non-elective aortic valve surgery event
Non-elective aortic valve surgery event up till 12 months post-OP
Time frame: 12 months post OP
Non-elective transcatheter re-intervention event
Non-elective transcatheter re-intervention post procedure event up till 12 months post-OP
Time frame: 12 months post OP
Major cardiac structural complications
Major cardiac structural complications event up till 12 months post-OP
Time frame: 12 months post OP
Major access site complications
Major access site complications event up till 12 months post-OP
Time frame: 12 months post OP
New pacemaker implantation event
New pacemaker implantation due to AV block event up till 12 months post-OP
Time frame: 12 months post OP
Acute Device Success Rate
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
Time frame: immediately post-OP
Procedural Success Rate
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.
Time frame: immediately post-OP
All-cause mortality
30-day all-cause mortality rate of subjects
Time frame: 30-day
All-cause mortality
1-year all-cause mortality rate of subjects
Time frame: 1-year
heart failure hospitalization
30-day heart failure hospitalization rate of subjects
Time frame: 30-day
heart failure hospitalization
1 year heart failure hospitalization rate of subjects
Time frame: 1-year
NYHA Functional Class
NYHA Functional Class of subjects at baseline
Time frame: Baseline
NYHA Functional Class
NYHA Functional Class of subjects at post-OP
Time frame: Post-OP
NYHA Functional Class
NYHA Functional Class of subjects at 1 month post-OP
Time frame: 1 month Post-OP
NYHA Functional Class
NYHA Functional Class of subjects at 6-month post-OP
Time frame: 6-month Post-OP
NYHA Functional Class
NYHA Functional Class of subjects at 12-month post-OP
Time frame: 12-month Post-OP
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Prince of Wales Hospital, Shatin, Hong Kong