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ART Trial: Transcatheter J-VALVE Versus Surgery for Aortic Regurgitation Therapy

NCT07453407 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1250

Last updated 2026-03-10

No results posted yet for this study

Summary

The overall purpose of ART trial is to establish the Safety and Efficacy of the J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement in Patients with Grade≥3+ Native Aortic Regurgitation.

Conditions

  • Aortic Regurgitation
  • Aortic Valve Insufficiency
  • Aortic Insufficiency

Interventions

DEVICE

J-VALVE Transfemoral Aortic Valve system

Transcatheter aortic valve replacement (TAVR) using J-VALVE Transfemoral Aortic Valve system

DEVICE

Commercially available surgical biological aortic valve replacement device

Surgical aortic valve replacement（SAVR）using commercially available surgical biological aortic valve replacement device

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Jian'an Wang, MD · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-05
Primary Completion
2029-03-31
Completion
2038-03-31

Countries

  • China

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 NCT07453407 on ClinicalTrials.gov