NCT00860730

PERCEVAL Pivotal Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Corcym S.r.l · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community. A minimum number of 8 European Centres will be involved in the clinical investigation. A minimum of 15 patients will be enrolled at each Investigational Centre. The clinical follow-up requires evaluations at discharge (or 30 days if the patient is still hospitalized), 3-6 and 12 months following the procedure.The primary objective of this clinical investigation is to assess the performance of the Perceval S valve at 3-6 months after implantation in high surgical risk patients, who require a surgical intervention to replace the aortic valve.

Detailed description

The design of the Perceval S prosthesis stems from the intention to offer an alternative to traditional flexible prostheses (stented and stentless biological valves) using conventional open-heart surgery. As a result of the sutureless implant procedure, in fact, patients could benefit from: Reducing aortic clamp times, with subsequent overall reduction of surgical timing and therefore reduction in related risks; Avoiding to pass the stitches through the annulus and sutures knotting, with consequent less risk of tearing aortic annulus and wall, damaging the bundle of His, embolizing foreign material in the vascular system.

Conditions

• Aortic Valve Replacement

Interventions

Type	Name	Description
DEVICE	Aortic valve replacement with Perceval aortic heart valve	Replacement of diseased or malfunctioning native aortic valve via traditional surgery (open chest) with the Perceval S prosthesis

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-10-01
• Completion: 2015-10-01
• First posted: 2009-03-12
• Last updated: 2022-07-08

Locations

9 sites across 4 countries: Belgium, France, Germany, Switzerland