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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01522352
Other study ID # CHU-0109
Secondary ID
Status Recruiting
Phase N/A
First received December 20, 2011
Last updated September 2, 2013
Start date March 2012
Est. completion date December 2013

Study information

Verified date September 2013
Source University Hospital, Clermont-Ferrand
Contact Patrick LACARIN
Phone 04 73 75 11 95
Email placarin@chu-clermontferrand.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 165
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand

Sponsors (5)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand Edwards Lifesciences, Ministry of Health, France, Sorin group, Italy, St. Jude Medical

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary measurement of postoperative trans-valvular mean gradient by echocardiography after 6 months Yes
Secondary Comparison between aortic annulus diameter measurement by preoperative CT angiography, transthoracic echocardiography and the aortic annulus' surgical size at six months Yes
Secondary Comparison between the aortic annulus measurement and the implanted bioprosthesis size at six months Yes
Secondary Surgical outcome at hospital at 6 months. Yes
Secondary Postoperative trans-valvular mean gradient by echocardiography at six months. Yes
Secondary Comparison of the transthoracic echocardiography estimated postoperative aortic surfaces at six months. Yes
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