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Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX

NCT01171625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 283

Last updated 2020-04-17

Study results available
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Summary

The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.

Conditions

Interventions

DEVICE

Implantation of CEP Magna Ease Model 3300TFX

Heart Valve Surgery

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2018-09-30
Completion
2018-09-30
FDA Device
Yes

Countries

  • United States
  • Austria
  • Canada
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01171625 on ClinicalTrials.gov