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J-Valve Transfemoral Pivotal Study

NCT06455787 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2026-05-04

No results posted yet for this study

Summary

The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR).

A Cardiac Magnetic Resonance (CMR) sub-study will examine if intervention for AR translates to improved ventricular remodeling, the impact of LV remodeling on clinical outcomes and quality of life, as well as volumetric and myocardial differences between genders.

Conditions

  • Aortic Valve Regurgitation
  • Aortic Valve Disease Mixed

Interventions

DEVICE

J-Valve Transfemoral (TF) System

Treatment includes using the J-Valve Transfemoral (TF) System, a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis and the J-Valve TF Delivery Device and Loading Accessories, during transcatheter aortic valve replacement (TAVR). The Edwards 16Fr eSheath+ Introducer Set may be used for the introduction and removal of the J-Valve TF System.

Sponsors & Collaborators

  • Minneapolis Heart Institute Foundation

    collaborator OTHER

  • Cardiovascular Research Foundation, New York

    collaborator OTHER

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

    lead INDUSTRY

Principal Investigators

  • Dean J Kereiakes, MD · The Christ Hospital Heart & Vascular Institute

  • Michael Reardon, MD · The Methodist Hospital Research Institute

  • Santiago Garcia, MD · The Christ Hospital and The Carl and Edyth Lindner Center for Research and Education

  • Tsuyoshi Kaneko, MD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-17
Primary Completion
2028-02-29
Completion
2032-02-29
FDA Device
Yes

Countries

  • United States
  • Canada
  • France
  • Japan
  • United Kingdom

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 NCT06455787 on ClinicalTrials.gov