Comparison Between Three Types of Stented Pericardial Aortic Valves

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01522352

Enrollment

165

Registered

2012-01-31

Start date

2012-03-31

Completion date

2013-12-31

Last updated

2013-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Replacement

Keywords

Bioprosthesis,, aortic valve replacement, Magna Ease, Mitroflow, Trifecta

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.

Interventions

PROCEDUREAortic 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)

Study design

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
measurement of postoperative trans-valvular mean gradient by echocardiography	after 6 months

Secondary

Measure	Time frame
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.

Countries

France

Contacts

Primary ContactPatrick LACARIN

placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026