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J-Valve TF Early Feasibility Study — JVTF EFS  

Aortic Valve Disease Clinical Trial

Official title:
J-Valve TF Early Feasibility Study

Clinical Trial 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.

Clinical Trial Description

The EFS is a prospective, single arm, multi-center, interventional study that will enroll up to 15 subjects in up to 10 centers in the United States and/or Canada and report the primary endpoint of all-cause death or disabling stroke at 30 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06034028
Study type Interventional
Source JC Medical, Inc.
Contact Clinical Affairs
Phone 650-477-2781
Email info@jcmedicalinc.com
Status Recruiting
Phase N/A
Start date October 16, 2023
Completion date June 25, 2029
View Details
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