Comparison Between Three Types of Stented Pericardial Aortic Valves

Not Applicable

• Conditions: Aortic Valve Replacement
• Interventions: Procedure: Aortic valve replacement by bioprosthesis

• Registration Number: NCT01522352
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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.

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 Timeline

• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-01-31
• Study Start: 2012-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-02
• Last Update Posted: 2013-09-04
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 165

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pericardial aortic valves	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)

Primary Outcome Measures

Name	Time	Method
measurement of postoperative trans-valvular mean gradient by echocardiography	after 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France