J-Valve Compassionate Use

• Conditions: Aortic Valve Insufficiency; Aortic Valve Disease; Aortic Valve Stenosis

• Registration Number: NCT03876964
• Lead Sponsor: JC Medical, Inc.

Brief Summary

J-Valve TF Compassionate Use cases approved on a case by case basis by the FDA

Detailed Description

The J-Valve is designed to treat patients with aortic valve disease requiring replacement. There are certain patient subsets that the J-Valve TF is uniquely able to treat and where there are no good alternative treatments for patients at high surgical risk. Physicians have applied for individual approval to treat patients with the J-Valve in certain clinical conditions.

Study Timeline

• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Exclusion Criteria

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified