Clinical trial NCT07021612: A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Patients With Pure Aortic Regurgitation
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Disease
Keywords: Transcatherter Aortic Valve Intervention
Lead sponsor: Prince of Wales Hospital, Shatin, Hong Kong
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

1. receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH
2. with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy
3. Deemed high risk for aortic valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists)
4. Capable of providing informed consent

Exclusion Criteria:

1. Evidence of intracardiac mass, thrombus or vegetation
2. Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
3. Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure
4. Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
5. Chronic Kidney Disease with eGFR \<30 ml/min/1.73m2.
6. Cardiogenic shock or other hemodynamic instability requiring inotropic support or ventricular assist device
7. Contraindicated for CT or MRI assessment

Primary outcomes:
measure: Presence of leaflet thrombosis
timeFrame: 6 month
measure: Presence of leaflet thrombosis
timeFrame: 6 month
measure: Presence of leaflet thrombosis
timeFrame: 6 month
Secondary outcomes:
measure: Magnetic Resonance Imaging (MRI)
timeFrame: 1 month
measure: Magnetic Resonance Imaging (MRI)
timeFrame: 1 month
measure: Magnetic Resonance Imaging (MRI)
timeFrame: 1 month
measure: Magnetic Resonance Imaging (MRI)
timeFrame: 1 month
measure: Computed Tomographic Endpoints
timeFrame: Baseline
measure: Computed Tomographic Endpoints
timeFrame: Up to 1-month post-OP
measure: Computed Tomographic Endpoints
timeFrame: 1-year
measure: Computed Tomographic Endpoints
timeFrame: Baseline
measure: Computed Tomographic Endpoints
timeFrame: Up to 1-month post-OP
measure: Computed Tomographic Endpoints
timeFrame: 1-year
measure: Computed Tomographic Endpoints
timeFrame: Baseline
measure: Computed Tomographic Endpoints
timeFrame: Upto 1-month post-OP
measure: Computed Tomographic Endpoints
timeFrame: 1-year
measure: Computed Tomographic Endpoints
timeFrame: Baseline
measure: Computed Tomographic Endpoints
timeFrame: Up to 1-month post-OP
measure: Computed Tomographic Endpoints
timeFrame: 6-month
measure: Computed Tomographic Endpoints
timeFrame: 1-year
measure: Computed Tomographic Endpoints
timeFrame: Up to 1-month post-OP
measure: Computed Tomographic Endpoints
timeFrame: 6-month
measure: Computed Tomographic Endpoints
timeFrame: 1-year
measure: Computed Tomographic Endpoints
timeFrame: Baseline
measure: Computed Tomographic Endpoints
timeFrame: Up to 1-month post-OP
measure: Computed Tomographic Endpoints
timeFrame: 6-month
measure: Computed Tomographic Endpoints
timeFrame: 1-year
measure: Echocardiographic Endpoints
timeFrame: Baseline
measure: Echocardiographic Endpoints
timeFrame: day 1-7
measure: Echocardiographic Endpoints
timeFrame: day 30
measure: Echocardiographic Endpoints
timeFrame: 6-month
measure: Echocardiographic Endpoints
timeFrame: 1-year
measure: Echocardiographic Endpoints
timeFrame: Baseline
measure: Echocardiographic Endpoints
timeFrame: day 1-7
measure: Echocardiographic Endpoints
timeFrame: day 30
measure: Echocardiographic Endpoints
timeFrame: 6-month
measure: Echocardiographic Endpoints
timeFrame: 1-year
measure: Echocardiographic Endpoints
timeFrame: Baseline
measure: Echocardiographic Endpoints
timeFrame: Day 1-7 post OP
measure: Echocardiographic Endpoints
timeFrame: Day30 post OP
measure: Echocardiographic Endpoints
timeFrame: 6 months post OP
measure: Echocardiographic Endpoints
timeFrame: 12 months post OP
measure: Echocardiographic Endpoints
timeFrame: Day 1-7 post OP
measure: Echocardiographic Endpoints
timeFrame: Day 30 post OP
measure: Echocardiographic Endpoints
timeFrame: 6 months post OP
measure: Echocardiographic Endpoints
timeFrame: 12 months post OP
measure: cardiovascular Mortality events
timeFrame: 12 months post OP
measure: Myocardial Infarction event
timeFrame: 12 months post OP
measure: Stroke event
timeFrame: 12 months post OP
measure: New onset renal failure event
timeFrame: 12 months post OP
measure: Severe Bleeding event
timeFrame: 12 months post OP
measure: Non-elective aortic valve surgery event
timeFrame: 12 months post OP
measure: Non-elective transcatheter re-intervention event
timeFrame: 12 months post OP
measure: Major cardiac structural complications
timeFrame: 12 months post OP
measure: Major access site complications
timeFrame: 12 months post OP
measure: New pacemaker implantation event
timeFrame: 12 months post OP
measure: Acute Device Success Rate
timeFrame: immediately post-OP
measure: Procedural Success Rate
timeFrame: immediately post-OP
measure: All-cause mortality
timeFrame: 30-day
measure: All-cause mortality
timeFrame: 1-year
measure: heart failure hospitalization
timeFrame: 30-day
measure: heart failure hospitalization
timeFrame: 1-year
measure: NYHA Functional Class
timeFrame: Baseline
measure: NYHA Functional Class
timeFrame: Post-OP
measure: NYHA Functional Class
timeFrame: 1 month Post-OP
measure: NYHA Functional Class
timeFrame: 6-month Post-OP
measure: NYHA Functional Class
timeFrame: 12-month Post-OP
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Shatin
Study officials:
References: