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

NCT07021612 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-06-15

No results posted yet for this study

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

Interventions

DEVICE

JenaValve

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

DEVICE

J-Valve

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

Sponsors & Collaborators

  • Prince of Wales Hospital, Shatin, Hong Kong

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2028-03-31
Completion
2028-09-30
FDA Device
Yes

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07021612 on ClinicalTrials.gov