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NCT Number: NCT07021612

A Clinical and Imaging Registry of Transcatheter Aortic Valve Implantation Using JenaValve System/ J-Valve System for Patients With Pure Aortic Regurgitation

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.

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Key information

Conditions

Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Hong Kong, Shatin, 0000

Location status: Recruiting

Location contact

Chak Yu So

CONTACT

[email protected]

85260338536

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

JenaValve

Device

JenaValve is a newly developed advanced TAVI system developed by Jenavalve Technology Inc.

J-Valve

Device

J-Valve is a newly developed advanced TAVI system developed by Genesis Medtech.

Primary outcomes

  1. Presence of leaflet thrombosis

    Time frame: 6 month

    Presence of hypoattenuated leaflet thickening (HALT) detected on 6 month follow-up computed tomography

  2. Presence of leaflet thrombosis

    Time frame: 6 month

    Presence of restricted leaflet motion (RELM) detected on 6 month follow-up computed tomography

  3. Presence of leaflet thrombosis

    Time frame: 6 month

    Presence of hypoattenuation affecting motion (HAM) detected on 6 month follow-up computed tomography

Secondary outcomes

  1. Magnetic Resonance Imaging (MRI)

    Time frame: 1 month

    Comparison of 4D-Flow pattern using MRI at 1 month post-OP vs pre-OP

  2. Magnetic Resonance Imaging (MRI)

    Time frame: 1 month

    Comparison of Aortic Valve Flow Velocity using MRI at 1 month post-OP vs pre-OP

  3. Magnetic Resonance Imaging (MRI)

    Time frame: 1 month

    Comparison of Aortic Wall shear stress using MRI at 1 month post-OP vs pre-OP

  4. Magnetic Resonance Imaging (MRI)

    Time frame: 1 month

    Comparison of Intraventricular flow pattern using MRI at 1 month post-OP vs pre-OP

  5. Computed Tomographic Endpoints

    Time frame: Baseline

    Presence of leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on CT images at baseline

  6. Computed Tomographic Endpoints

    Time frame: Up to 1-month post-OP

    Presence of leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on CT images at post-OP

  7. Computed Tomographic Endpoints

    Time frame: 1-year

    Presence of leaflet thrombosis (hypoattenuated leaflet thickening (HALT) on CT images at 1 year post-OP

  8. Computed Tomographic Endpoints

    Time frame: Baseline

    Presence of leaflet thrombosis (restricted leaflet motion (RELM)) on CT images at baseline

  9. Computed Tomographic Endpoints

    Time frame: Up to 1-month post-OP

    Presence of leaflet thrombosis (restricted leaflet motion (RELM)) on CT images at post-OP

  10. Computed Tomographic Endpoints

    Time frame: 1-year

    Presence of leaflet thrombosis (restricted leaflet motion (RELM)) on CT images at 1 year post-OP

  11. Computed Tomographic Endpoints

    Time frame: Baseline

    Presence of leaflet thrombosis (hypoattenuation affecting motion (HAM )on CT images at baseline

  12. Computed Tomographic Endpoints

    Time frame: Upto 1-month post-OP

    Presence of leaflet thrombosis (hypoattenuation affecting motion (HAM )on CT images at post-OP

  13. Computed Tomographic Endpoints

    Time frame: 1-year

    Presence of leaflet thrombosis (hypoattenuation affecting motion (HAM )on CT images at 1 year post-OP

  14. Computed Tomographic Endpoints

    Time frame: Baseline

    To obtain the native valve dimensions using CT imaging at pre-OP (baseline)

  15. Computed Tomographic Endpoints

    Time frame: Up to 1-month post-OP

    To compare the impanted Transcatheter valve dimensions using CT imaging with baseline at post-OP

  16. Computed Tomographic Endpoints

    Time frame: 6-month

    To compare the impanted Transcatheter valve dimensions using CT imaging with baseline at 6 month post-OP

  17. Computed Tomographic Endpoints

    Time frame: 1-year

    To compare the impanted Transcatheter valve dimensions using CT imaging with baseline at 12 month post-OP

  18. Computed Tomographic Endpoints

    Time frame: Up to 1-month post-OP

    To obtain the impanted Transcatheter valve location using CT imaging at post-OP

  19. Computed Tomographic Endpoints

    Time frame: 6-month

    To compare the impanted Transcatheter valve location using CT imaging with post-OP at 6 month post-OP

  20. Computed Tomographic Endpoints

    Time frame: 1-year

    To compare the impanted Transcatheter valve location using CT imaging with post-OP at 12 month post-OP

  21. Computed Tomographic Endpoints

    Time frame: Baseline

    To obtain the native valve leaflet overhang using CT imaging at pre-OP (baseline)

  22. Computed Tomographic Endpoints

    Time frame: Up to 1-month post-OP

    To obtain the impanted valve leaflet overhang using CT imaging at post-OP

  23. Computed Tomographic Endpoints

    Time frame: 6-month

    To compare the impanted valve leaflet overhang using CT imaging with post-OP at 6 month post-OP

  24. Computed Tomographic Endpoints

    Time frame: 1-year

    To compare the impanted valve leaflet overhang using CT imaging with post-OP at 12 month post-OP

  25. Echocardiographic Endpoints

    Time frame: Baseline

    To grade AR Severity using echocardiography at baseline ii. Mean Aortic valve pressure gradient iii. Left Ventricular Ejection Fraction (LVEF) iv. Paravalvular leak severity

  26. Echocardiographic Endpoints

    Time frame: day 1-7

    To grade AR Severity using echocardiography at Day 1-7 post-OP

  27. Echocardiographic Endpoints

    Time frame: day 30

    To grade AR Severity using echocardiography at Day30 post-OP

  28. Echocardiographic Endpoints

    Time frame: 6-month

    To grade AR Severity using echocardiography at 6 months post-OP

  29. Echocardiographic Endpoints

    Time frame: 1-year

    To grade AR Severity using echocardiography at 1 year post-OP

  30. Echocardiographic Endpoints

    Time frame: Baseline

    To obtain Mean Aortic valve pressure gradient using echocardiography at baseline

  31. Echocardiographic Endpoints

    Time frame: day 1-7

    To obtain Mean Aortic valve pressure gradient using echocardiography at Day 1-7 post OP

  32. Echocardiographic Endpoints

    Time frame: day 30

    To obtain Mean Aortic valve pressure gradient using echocardiography at Day 30 post OP

  33. Echocardiographic Endpoints

    Time frame: 6-month

    To obtain Mean Aortic valve pressure gradient using echocardiography at 6 months post OP

  34. Echocardiographic Endpoints

    Time frame: 1-year

    To obtain Mean Aortic valve pressure gradient using echocardiography at 12 months post OP

  35. Echocardiographic Endpoints

    Time frame: Baseline

    To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at baseline

  36. Echocardiographic Endpoints

    Time frame: Day 1-7 post OP

    To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at Day 1-7 post OP

  37. Echocardiographic Endpoints

    Time frame: Day30 post OP

    To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at Day 30 post OP

  38. Echocardiographic Endpoints

    Time frame: 6 months post OP

    To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at 6 months post OP

  39. Echocardiographic Endpoints

    Time frame: 12 months post OP

    To obtain Left Ventricular Ejection Fraction (LVEF) using echocardiography at 12 months post OP

  40. Echocardiographic Endpoints

    Time frame: Day 1-7 post OP

    To evaluate Paravalvular leak severity using echocardiography at Day 1-7 post OP

  41. Echocardiographic Endpoints

    Time frame: Day 30 post OP

    To evaluate Paravalvular leak severity using echocardiography at Day 30 post OP

  42. Echocardiographic Endpoints

    Time frame: 6 months post OP

    To evaluate Paravalvular leak severity using echocardiography at 6 months post OP

  43. Echocardiographic Endpoints

    Time frame: 12 months post OP

    To evaluate Paravalvular leak severity using echocardiography at 12 months post OP

  44. cardiovascular Mortality events

    Time frame: 12 months post OP

    cardiovascular Mortality event up till 12 months post-OP

  45. Myocardial Infarction event

    Time frame: 12 months post OP

    Myocardial Infarction (MI) event up till 12 months post-OP

  46. Stroke event

    Time frame: 12 months post OP

    Stroke event up till 12 months post-OP

  47. New onset renal failure event

    Time frame: 12 months post OP

    New onset renal failure requiring unplanned dialysis or renal replacement therapyevent up till 12 months post-OP

  48. Severe Bleeding event

    Time frame: 12 months post OP

    Severe Bleeding (includes fatal, life-threatening and extensive bleeding as defined by VARC) event up till 12 months post-OP

  49. Non-elective aortic valve surgery event

    Time frame: 12 months post OP

    Non-elective aortic valve surgery event up till 12 months post-OP

  50. Non-elective transcatheter re-intervention event

    Time frame: 12 months post OP

    Non-elective transcatheter re-intervention post procedure event up till 12 months post-OP

  51. Major cardiac structural complications

    Time frame: 12 months post OP

    Major cardiac structural complications event up till 12 months post-OP

  52. Major access site complications

    Time frame: 12 months post OP

    Major access site complications event up till 12 months post-OP

  53. New pacemaker implantation event

    Time frame: 12 months post OP

    New pacemaker implantation due to AV block event up till 12 months post-OP

  54. Acute Device Success Rate

    Time frame: immediately post-OP

    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

  55. Procedural Success Rate

    Time frame: immediately post-OP

    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.

  56. All-cause mortality

    Time frame: 30-day

    30-day all-cause mortality rate of subjects

  57. All-cause mortality

    Time frame: 1-year

    1-year all-cause mortality rate of subjects

  58. heart failure hospitalization

    Time frame: 30-day

    30-day heart failure hospitalization rate of subjects

  59. heart failure hospitalization

    Time frame: 1-year

    1 year heart failure hospitalization rate of subjects

  60. NYHA Functional Class

    Time frame: Baseline

    NYHA Functional Class of subjects at baseline

  61. NYHA Functional Class

    Time frame: Post-OP

    NYHA Functional Class of subjects at post-OP

  62. NYHA Functional Class

    Time frame: 1 month Post-OP

    NYHA Functional Class of subjects at 1 month post-OP

  63. NYHA Functional Class

    Time frame: 6-month Post-OP

    NYHA Functional Class of subjects at 6-month post-OP

  64. NYHA Functional Class

    Time frame: 12-month Post-OP

    NYHA Functional Class of subjects at 12-month post-OP

Sponsors and collaborators

Lead sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Other

Registry information

Official study 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

Acronym: CAIR-JAR

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 15, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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