NCT03025971

Safety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation

Efficacy and Safety Evaluation for The Interventional Aortic Valve Bioprosthesis and Delivery System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation With Elevated Surgical Risk

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: JC Medical, Inc., an affiliate of Edwards Lifesciences LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multicenter, nonrandomized, single-arm, clinical study.

Detailed description

To evaluate the safety and efficacy of the J-Valve Ausper system for the treatment of patients with severe aortic stenosis and/or aortic regurgitation with elevated risk for surgery.

Conditions

• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	J-Valve Transcatheter Aortic valve replacement	Transapical Transcatheter Aortic Valve Replacement

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-04-01
• Completion: 2020-04-01
• First posted: 2017-01-20
• Last updated: 2024-09-19

Locations

3 sites across 1 country: China