Comparison Between Three Types of Stented Pericardial Aortic Valves

Aortic Valve Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01522352
• Other study ID #: CHU-0109
• 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

• Aortic Valve Replacement

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