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

NCT07021612 | Recruiting DMC FDA Device

• 1 other identifier: 2025.079
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Disease

Keywords

Transcatherter Aortic Valve Intervention

Outcome Measures

Primary Outcomes (3)

• Presence of leaflet thrombosis

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

  6 month

• Presence of leaflet thrombosis

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

  6 month

• Presence of leaflet thrombosis

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

  6 month

Secondary Outcomes (64)

• Magnetic Resonance Imaging (MRI)

  1 month

• Magnetic Resonance Imaging (MRI)

  1 month

• Magnetic Resonance Imaging (MRI)

  1 month

• Magnetic Resonance Imaging (MRI)

  1 month

• Computed Tomographic Endpoints

  Baseline

Study Arms (1)

Interventional group

Patient implanted with J-Valve or JenaValve TAVI system

Device: JenaValve; Device: J-Valve

Interventions

JenaValve DEVICE

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

Interventional group

J-Valve DEVICE

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

Interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince of Wales Hospital, Shatin, Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Shatin, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 15, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

HK (1)