Aortic Valve DiseaseCAIR-JARNCT07021612
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 of Aortic Valve Disease, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- JenaValve and J-Valve
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2025to 30 Sep 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy
Who may be able to join
- receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH
- with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy
- Deemed high risk for aortic valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists)
- Capable of providing informed consent
Who cannot join
- Evidence of intracardiac mass, thrombus or vegetation
- Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
- Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure
- Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
- Chronic Kidney Disease with eGFR <30 ml/min/1.73m2.
- Cardiogenic shock or other hemodynamic instability requiring inotropic support or ventricular assist device
- Contraindicated for CT or MRI assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong, Shatin, 0000
Chak Yu So, 85260338536, kentso987@gmail.com
About this study
Official title: 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
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.
- Conditions
- Aortic Valve Disease
- Being tested
- JenaValve, J-Valve
- Keywords
- Transcatherter Aortic Valve Intervention
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JenaValveDevice
JenaValve is a newly developed advanced TAVI system developed by Jenavalve Technology Inc.
J-ValveDevice
J-Valve is a newly developed advanced TAVI system developed by Genesis Medtech.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Patient implanted with J-Valve or JenaValve TAVI system Receives: Device: JenaValve; Device: J-Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of leaflet thrombosis
Presence of hypoattenuated leaflet thickening (HALT) detected on 6 month follow-up computed tomography
Measured: 6 month
Presence of leaflet thrombosis
Presence of restricted leaflet motion (RELM) detected on 6 month follow-up computed tomography
Measured: 6 month
Presence of leaflet thrombosis
Presence of hypoattenuation affecting motion (HAM) detected on 6 month follow-up computed tomography
Measured: 6 month
Secondary outcomes (64)
Magnetic Resonance Imaging (MRI)
Comparison of 4D-Flow pattern using MRI at 1 month post-OP vs pre-OP
Measured: 1 month
Magnetic Resonance Imaging (MRI)
Comparison of Aortic Valve Flow Velocity using MRI at 1 month post-OP vs pre-OP
Measured: 1 month
Magnetic Resonance Imaging (MRI)
Comparison of Aortic Wall shear stress using MRI at 1 month post-OP vs pre-OP
Measured: 1 month
Magnetic Resonance Imaging (MRI)
Comparison of Intraventricular flow pattern using MRI at 1 month post-OP vs pre-OP
Measured: 1 month
Computed Tomographic Endpoints
Presence of leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on CT images at baseline
Measured: Baseline
Computed Tomographic Endpoints
Presence of leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on CT images at post-OP
Measured: 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
Measured: 1-year
Computed Tomographic Endpoints
Presence of leaflet thrombosis (restricted leaflet motion (RELM)) on CT images at baseline
Measured: Baseline
Computed Tomographic Endpoints
Presence of leaflet thrombosis (restricted leaflet motion (RELM)) on CT images at post-OP
Measured: 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
Measured: 1-year
Computed Tomographic Endpoints
Presence of leaflet thrombosis (hypoattenuation affecting motion (HAM )on CT images at baseline
Measured: Baseline
Computed Tomographic Endpoints
Presence of leaflet thrombosis (hypoattenuation affecting motion (HAM )on CT images at post-OP
Measured: Upto 1-month post-OP
Computed Tomographic Endpoints
Presence of leaflet thrombosis (hypoattenuation affecting motion (HAM )on CT images at 1 year post-OP
Measured: 1-year
Computed Tomographic Endpoints
To obtain the native valve dimensions using CT imaging at pre-OP (baseline)
Measured: Baseline
Computed Tomographic Endpoints
To compare the impanted Transcatheter valve dimensions using CT imaging with baseline at post-OP
Measured: 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
Measured: 6-month
Computed Tomographic Endpoints
To compare the impanted Transcatheter valve dimensions using CT imaging with baseline at 12 month post-OP
Measured: 1-year
Computed Tomographic Endpoints
To obtain the impanted Transcatheter valve location using CT imaging at post-OP
Measured: 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
Measured: 6-month
Computed Tomographic Endpoints
To compare the impanted Transcatheter valve location using CT imaging with post-OP at 12 month post-OP
Measured: 1-year
Computed Tomographic Endpoints
To obtain the native valve leaflet overhang using CT imaging at pre-OP (baseline)
Measured: Baseline
Computed Tomographic Endpoints
To obtain the impanted valve leaflet overhang using CT imaging at post-OP
Measured: 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
Measured: 6-month
Computed Tomographic Endpoints
To compare the impanted valve leaflet overhang using CT imaging with post-OP at 12 month post-OP
Measured: 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
Measured: Baseline
Echocardiographic Endpoints
To grade AR Severity using echocardiography at Day 1-7 post-OP
Measured: day 1-7
Echocardiographic Endpoints
To grade AR Severity using echocardiography at Day30 post-OP
Measured: day 30
Echocardiographic Endpoints
To grade AR Severity using echocardiography at 6 months post-OP
Measured: 6-month
Echocardiographic Endpoints
To grade AR Severity using echocardiography at 1 year post-OP
Measured: 1-year
Echocardiographic Endpoints
To obtain Mean Aortic valve pressure gradient using echocardiography at baseline
Measured: Baseline
Echocardiographic Endpoints
To obtain Mean Aortic valve pressure gradient using echocardiography at Day 1-7 post OP
Measured: day 1-7
Echocardiographic Endpoints
To obtain Mean Aortic valve pressure gradient using echocardiography at Day 30 post OP
Measured: day 30
Echocardiographic Endpoints
To obtain Mean Aortic valve pressure gradient using echocardiography at 6 months post OP
Measured: 6-month
Echocardiographic Endpoints
To obtain Mean Aortic valve pressure gradient using echocardiography at 12 months post OP
Measured: 1-year
Echocardiographic Endpoints
To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at baseline
Measured: Baseline
Echocardiographic Endpoints
To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at Day 1-7 post OP
Measured: Day 1-7 post OP
Echocardiographic Endpoints
To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at Day 30 post OP
Measured: Day30 post OP
Echocardiographic Endpoints
To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at 6 months post OP
Measured: 6 months post OP
Echocardiographic Endpoints
To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at 12 months post OP
Measured: 12 months post OP
Echocardiographic Endpoints
To evaluate Paravalvular leak severity using echocardiography at Day 1-7 post OP
Measured: Day 1-7 post OP
Echocardiographic Endpoints
To evaluate Paravalvular leak severity using echocardiography at Day 30 post OP
Measured: Day 30 post OP
Echocardiographic Endpoints
To evaluate Paravalvular leak severity using echocardiography at 6 months post OP
Measured: 6 months post OP
Echocardiographic Endpoints
To evaluate Paravalvular leak severity using echocardiography at 12 months post OP
Measured: 12 months post OP
cardiovascular Mortality events
cardiovascular Mortality event up till 12 months post-OP
Measured: 12 months post OP
Myocardial Infarction event
Myocardial Infarction (MI) event up till 12 months post-OP
Measured: 12 months post OP
Stroke event
Stroke event up till 12 months post-OP
Measured: 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
Measured: 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
Measured: 12 months post OP
Non-elective aortic valve surgery event
Non-elective aortic valve surgery event up till 12 months post-OP
Measured: 12 months post OP
Non-elective transcatheter re-intervention event
Non-elective transcatheter re-intervention post procedure event up till 12 months post-OP
Measured: 12 months post OP
Major cardiac structural complications
Major cardiac structural complications event up till 12 months post-OP
Measured: 12 months post OP
Major access site complications
Major access site complications event up till 12 months post-OP
Measured: 12 months post OP
New pacemaker implantation event
New pacemaker implantation due to AV block event up till 12 months post-OP
Measured: 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
Measured: 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.
Measured: immediately post-OP
All-cause mortality
30-day all-cause mortality rate of subjects
Measured: 30-day
All-cause mortality
1-year all-cause mortality rate of subjects
Measured: 1-year
heart failure hospitalization
30-day heart failure hospitalization rate of subjects
Measured: 30-day
heart failure hospitalization
1 year heart failure hospitalization rate of subjects
Measured: 1-year
NYHA Functional Class
NYHA Functional Class of subjects at baseline
Measured: Baseline
NYHA Functional Class
NYHA Functional Class of subjects at post-OP
Measured: Post-OP
NYHA Functional Class
NYHA Functional Class of subjects at 1 month post-OP
Measured: 1 month Post-OP
NYHA Functional Class
NYHA Functional Class of subjects at 6-month post-OP
Measured: 6-month Post-OP
NYHA Functional Class
NYHA Functional Class of subjects at 12-month post-OP
Measured: 12-month Post-OP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start1 Apr 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr So Chak Yu kent, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021612
- Sponsor's protocol ID
- 2025.079
- Acronym
- CAIR-JAR
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07021612
- Acronym / sponsor ID
- CAIR-JAR / 2025.079
- Conditions
- Aortic Valve Disease
- Keywords
- Transcatherter Aortic Valve Intervention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional group | – | Device: JenaValve, Device: J-ValvePatient implanted with J-Valve or JenaValve TAVI system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy
Key inclusion criteria (4 listed)
- receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH
- with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy
- Deemed high risk for aortic valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists)
- Capable of providing informed consent
Key exclusion criteria (7 listed)
- Evidence of intracardiac mass, thrombus or vegetation
- Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
- Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure
- Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
- Chronic Kidney Disease with eGFR <30 ml/min/1.73m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JenaValveJenaValve is a newly developed advanced TAVI system developed by Jenavalve Technology Inc. | Device | Interventional group |
| J-ValveJ-Valve is a newly developed advanced TAVI system developed by Genesis Medtech. | Device | Interventional group |
Primary outcome
Presence of leaflet thrombosis
Time frame: 6 month
Presence of hypoattenuated leaflet thickening (HALT) detected on 6 month follow-up computed tomography
Presence of leaflet thrombosis
Time frame: 6 month
Presence of restricted leaflet motion (RELM) detected on 6 month follow-up computed tomography
Presence of leaflet thrombosis
Time frame: 6 month
Presence of hypoattenuation affecting motion (HAM) detected on 6 month follow-up computed tomography
64 secondary outcomes
Magnetic Resonance Imaging (MRI)
Time frame: 1 month
Magnetic Resonance Imaging (MRI)
Time frame: 1 month
Magnetic Resonance Imaging (MRI)
Time frame: 1 month
Magnetic Resonance Imaging (MRI)
Time frame: 1 month
Computed Tomographic Endpoints
Time frame: Baseline
Computed Tomographic Endpoints
Time frame: Up to 1-month post-OP
Computed Tomographic Endpoints
Time frame: 1-year
Computed Tomographic Endpoints
Time frame: Baseline
Computed Tomographic Endpoints
Time frame: Up to 1-month post-OP
Computed Tomographic Endpoints
Time frame: 1-year
Computed Tomographic Endpoints
Time frame: Baseline
Computed Tomographic Endpoints
Time frame: Upto 1-month post-OP
Computed Tomographic Endpoints
Time frame: 1-year
Computed Tomographic Endpoints
Time frame: Baseline
Computed Tomographic Endpoints
Time frame: Up to 1-month post-OP
Computed Tomographic Endpoints
Time frame: 6-month
Computed Tomographic Endpoints
Time frame: 1-year
Computed Tomographic Endpoints
Time frame: Up to 1-month post-OP
Computed Tomographic Endpoints
Time frame: 6-month
Computed Tomographic Endpoints
Time frame: 1-year
Computed Tomographic Endpoints
Time frame: Baseline
Computed Tomographic Endpoints
Time frame: Up to 1-month post-OP
Computed Tomographic Endpoints
Time frame: 6-month
Computed Tomographic Endpoints
Time frame: 1-year
Echocardiographic Endpoints
Time frame: Baseline
Echocardiographic Endpoints
Time frame: day 1-7
Echocardiographic Endpoints
Time frame: day 30
Echocardiographic Endpoints
Time frame: 6-month
Echocardiographic Endpoints
Time frame: 1-year
Echocardiographic Endpoints
Time frame: Baseline
Echocardiographic Endpoints
Time frame: day 1-7
Echocardiographic Endpoints
Time frame: day 30
Echocardiographic Endpoints
Time frame: 6-month
Echocardiographic Endpoints
Time frame: 1-year
Echocardiographic Endpoints
Time frame: Baseline
Echocardiographic Endpoints
Time frame: Day 1-7 post OP
Echocardiographic Endpoints
Time frame: Day30 post OP
Echocardiographic Endpoints
Time frame: 6 months post OP
Echocardiographic Endpoints
Time frame: 12 months post OP
Echocardiographic Endpoints
Time frame: Day 1-7 post OP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of leaflet thrombosis (time frame: 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.