Comparison Between Three Types of Stented Pericardial Aortic Valves

September 2, 2013 updated by: University Hospital, Clermont-Ferrand

Comparison of Short and Mid-term Hemodynamic Performance Between Three Types of Stented Pericardial Aortic Valves

This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

According to the French database Society for Thoracic and Cardiovascular Surgery, 11,621 patients underwent aortic valve replacement in 2007. Over 77% of biologic prosthetic valves were used. Among these biologic valves, those in pericardium are mainly used in all French cardiac surgery centers.

Since March 2010, a new pericardial aortic valve has obtained a CE mark, allowing cardiac surgery centers in Europe to implement it in humans.

Hemodynamic performance of different biologic valves has never been measured. This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.

Study Type

Interventional

Enrollment (Anticipated)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged between 18 and 85 years who need aortic valve replacement (no endocarditis) With Bioprosthesis, with or without myocardial revascularization, with or without tricuspid valve repair surgery

Exclusion Criteria:

  • no endocarditis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pericardial aortic valves
Comparison of short and mid-term hemodynamic performance between three types of stented pericardial aortic valves: Trifecta aortic valve (St. Jude Medical), Mitroflow aortic valve (Sorin Group), Magna Ease (Edwards Lifesciences)
Procedure: Aortic valve replacement by bioprosthesis
Comparison of short and mid-term hemodynamic performance between three types of stented pericardial aortic valves: Trifecta aortic valve (St. Jude Medical), Mitroflow aortic valve (Sorin Group), Magna Ease (Edwards Lifesciences)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
measurement of postoperative trans-valvular mean gradient by echocardiography
Time Frame: after 6 months
after 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison between aortic annulus diameter measurement by preoperative CT angiography, transthoracic echocardiography and the aortic annulus' surgical size
Time Frame: at six months
at six months
Comparison between the aortic annulus measurement and the implanted bioprosthesis size
Time Frame: at six months
at six months
Surgical outcome at hospital
Time Frame: at 6 months.
at 6 months.
Postoperative trans-valvular mean gradient by echocardiography
Time Frame: at six months.
at six months.
Comparison of the transthoracic echocardiography estimated postoperative aortic surfaces
Time Frame: at six months.
at six months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Ministry of Health, France
Abbott Medical Devices
Edwards Lifesciences
Sorin group, Italy

Investigators

  • Principal Investigator: Kasra AZARNOUSH, MD, PhD, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

January 27, 2012

First Posted (Estimate)

January 31, 2012

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

September 2, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHU-0109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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