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J-Valve Transfemoral Pivotal Study — JOURNEY  

Aortic Valve Regurgitation Clinical Trial

Official title:
J-Valve to Treat Aortic Regurgitation Via Transcatheter Therapy

Clinical Trial 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).

Clinical Trial Description

This is a prospective, single arm, multi-center, interventional pivotal study that will enroll up to 171 subjects in up to 25 investigational sites in the United States and Canada. The subjects will then be followed 5-years post-procedure of the J-Valve TF System. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06455787
Study type Interventional
Source JC Medical, Inc.
Contact Sheri Halverson, MPh
Phone 650-477-2781
Email shalverson@jcmedicalinc.com
Status Not yet recruiting
Phase N/A
Start date July 2024
Completion date July 2030
View Details
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