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Safety and Effectiveness Study of Perceval S Valve for Extended CE Mark

NCT01368666 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 658

Last updated 2024-03-06

No results posted yet for this study

Summary

The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Conditions

  • Aortic Valve Replacement

Interventions

DEVICE

Perceval S Valve Prosthesis

Replacement of diseased or malfunctioning native aortic valve with the Perceval S valve prosthesis

Sponsors & Collaborators

  • Corcym S.r.l

    lead INDUSTRY

Principal Investigators

  • A. Haverich, Prof. · Hannover Medical School

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-23
Primary Completion
2014-10-31
Completion
2020-01-31

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Netherlands
  • Poland
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01368666 on ClinicalTrials.gov