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Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

NCT01651052 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2019-07-26

Study results available
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Summary

The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.

Conditions

Interventions

PROCEDURE

Heart Valve Surgery

Implant of an aortic valve, Model 11000

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Jerzy Sadowski, MD · John Paul II Hospital

  • Jacek Rozanski, MD · The Cardinal Stefan Wyszyński Institute of Cardiology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • Poland

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 NCT01651052 on ClinicalTrials.gov