NCT03481387

PERCEVAL S Valve Clinical Study for Chinese Registration

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Corcym S.r.l · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open, single arm, multi-center clinical study in China. The primary objective of this study is to demonstrate the safety and effectiveness of the PERCEVAL S heart valve when used to replace a diseased native or malfunctioning prosthetic aortic valve in the indicated Chinese population for tissue heart valve replacement and suitable to the PERCEVAL S valve. The secondary objectives are to collect all relevant device and subject demographics, procedural and hospital discharge, short and long-term data, as described in the secondary endpoints section.

Conditions

• Aortic Valve Disease
• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Aortic Valve Replacement with Perceval S sutureless heart valve	Patients will be treated with the PERCEVAL S heart valve (PERCEVAL S valve) which is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The PERCEVAL S valve is designed to offer an alternative to surgically implanted flexible prostheses (stented and stentless biological valves). A special feature of the device is that it is self-anchoring and does not require sutures to be fixed to the implant site.

Timeline

• Start date: 2018-01-26
• Primary completion: 2020-09-25
• Completion: 2024-02-25
• First posted: 2018-03-29
• Last updated: 2024-03-06

Locations

1 site across 1 country: China