Clinical evaluation of percutaneous implantation of the CoreValve aortic valve prosthesis. Safety and performance study on patients at high risk for surgical valve replacement.

Completed

• Conditions: aorta valve stenosis; leaking heart valve; 10046973

• Registration Number: NL-OMON29825
• Lead Sponsor: CoreValve

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

significant aortic valve stenosis, euroscore higher than 15 and/or age higher than 75 years

Exclusion Criteria

previous aortic valve replacement, recent or evalutive CVA, kreatine clearance less than 20ml per minute, mitral and tricuspid insuffiency more than grade 2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>· Performance is defined by device functionality based on the<br /><br>investigator evaluation rating on the system and the procedure success rate at<br /><br>discharge defined as a correct prosthesis valve function without any major<br /><br>adverse event (MAE) at discharge (or 10 days whichever occurs first)<br /><br><br /><br>· Safety is defined as clinical outcome (composite of MAE including<br /><br>major adverse cardiac events) at discharge and 30 days.<br /><br><br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>· Clinical : patient functional status (NYHA) from discharge until 48<br /><br>month follow-up, patient neurological status (NIH stroke scale) from discharge<br /><br>to 6 month follow-up. MAE from 3 month to 48 month follow-up<br /><br><br /><br>· Performance: valve performance , valve migration, paravalvular leak<br /><br>assessed by Doppler echocardiography from 1 to 48 month follow-up,<br /><br><br /><br></p><br>