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J-Valve TF Early Feasibility Study

NCT06034028 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-07-11

No results posted yet for this study

Summary

The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.

Conditions

  • Aortic Valve Disease
  • Aortic Valve Insufficiency
  • Aortic Regurgitation

Interventions

DEVICE

J-Valve TF System

The J-Valve TF System is a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis, J-Valve TF Delivery Device, and Loading Accessories.

Sponsors & Collaborators

  • JC Medical, Inc., an affiliate of Edwards Lifesciences LLC

    lead INDUSTRY

Principal Investigators

  • Dean J Kereiakes, MD · The Christ Hospital

  • Michael J Reardon, MD · The Methodist Hospital Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-16
Primary Completion
2024-07-17
Completion
2029-08-25
FDA Device
Yes

Countries

  • United States

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 NCT06034028 on ClinicalTrials.gov