NCT02668484

REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation

Randomized Comparison of Repositionable and Balloon-Expandable Prostheses in Patients Undergoing Trans-catheter Aortic Valve Implantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: LMU Klinikum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There are different aortic valve prosthesis used for treatment of aortic valve disease through catheter-based procedures. The current study aims to compare two different aortic valve prosthesis regarding their outcomes at 30-day and 2-year follow-up.

Detailed description

Important improvements in aortic valve prostheses technology has been made aiming comparable performance of these prosthesis to surgical valve ones. The experience with the early generation of aortic valve prostheses revealed some important differences regarding the incidence of paravalvular leakage, need for pacemaker or valve thrombosis among them. Currently the new generations of valve prostheses such as Sapien 3 balloon-expandable valve and Lotus, repositionable valve are the most frequently used devices. There are registry data about the clinical performance of these valve types but a randomized comparison is missing.

Conditions

• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	repositionable valve prosthesis	repositionable valve prosthesis implanted via trans-femoral and trans-catheter route
DEVICE	balloon-expandable valve prosthesis	balloon-expandable valve prosthesis implanted via trans-femoral and trans-catheter route

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-05-01
• Completion: 2019-05-31
• First posted: 2016-01-29
• Last updated: 2019-06-03

Locations

3 sites across 2 countries: Germany, Italy