NCT01598844

JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation

The JenaValve" EvalUation of Long Term Performance and Safety In PaTients With SEvere Aortic Stenosis oR Aortic Insufficiency

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 210 (actual)
• Sponsor: JenaValve Technology, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.

Detailed description

The objective of this study is to evaluate the long term safety and effectiveness of the CE-marked JenaValve System Transapical in an elderly patient population with severe aortic stenosis and/or aortic insufficiency who are at high risk for open surgical aortic valve replacement. The target study population will consist of elderly patients suffering from severe symptomatic degenerative aortic valve stenosis and/or aortic insufficiency who show an increased risk for an open aortic valve replacement surgery due to existing co-morbidities.

Conditions

• Aortic Stenosis
• Aortic Insufficiency
• Aortic Regurgitation

Interventions

Type	Name	Description
DEVICE	Transcatheter aortic valve replacement	Transcatheter aortic valve replacement via a transapical access

Timeline

• Start date: 2012-05-30
• Primary completion: 2015-08-27
• Completion: 2018-07-31
• First posted: 2012-05-15
• Last updated: 2020-11-24

Locations

15 sites across 4 countries: Germany, Netherlands, Switzerland, United Kingdom