JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation

JenaValve Technology

Status: Completed

Conditions: Aortic Regurgitation; Aortic Insufficiency; Aortic Stenosis

Treatments: Device: Transcatheter aortic valve replacement

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01598844

JV03PMS

Details and patient eligibility

About

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

Full 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.

Enrollment: 210 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suitable for TAVI with the JenaValve according to instructions for use

Exclusion criteria

• Patients unsuitable for TAVI with the JenaValve according to instructions for use

Trial design

210 participants in 2 patient groups

High risk patients with aortic stenosis

Description:

Transapical aortic valve implantation using a transcatheter heart valve for aortic stenosis.

Treatment:

Device: Transcatheter aortic valve replacement

High risk patients with AI

Description:

Transapical aortic valve implantation using a transcatheter heart valve for aortic regurgitation.

Treatment:

Device: Transcatheter aortic valve replacement