Clinical trial NCT01522352: Comparison Between Three Types of Stented Pericardial Aortic Valves
Official title: Comparison of Short and Mid-term Hemodynamic Performance Between Three Types of Stented Pericardial Aortic Valves
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Replacement
Keywords: Bioprosthesis,
aortic valve replacement
Magna Ease
Mitroflow
Trifecta
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
name: Abbott Medical Devices
name: Sorin group, Italy
name: Ministry of Health, France
First posted: 2012-01-31
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: measurement of postoperative trans-valvular mean gradient by echocardiography
timeFrame: after 6 months
Secondary outcomes:
measure: Comparison between aortic annulus diameter measurement by preoperative CT angiography, transthoracic echocardiography and the aortic annulus' surgical size
timeFrame: at six months
measure: Comparison between the aortic annulus measurement and the implanted bioprosthesis size
timeFrame: at six months
measure: Surgical outcome at hospital
timeFrame: at 6 months.
measure: Postoperative trans-valvular mean gradient by echocardiography
timeFrame: at six months.
measure: Comparison of the transthoracic echocardiography estimated postoperative aortic surfaces
timeFrame: at six months.
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Kasra AZARNOUSH, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azarnoush K, Pereira B, Duale C, Dorigo E, Farhat M, Innorta A, Dauphin N, Geoffroy E, Chabrot P, Camilleri L. Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial. Trials. 2013 Dec 3;14:413. doi: 10.1186/1745-6215-14-413.