Comparison Between Three Types of Stented Pericardial Aortic Valves
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: pericardial aortic valves 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) |
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)
|
Outcome Measures
Primary Outcome Measures
- measurement of postoperative trans-valvular mean gradient by echocardiography [after 6 months]
Secondary Outcome Measures
- 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.]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Clermont-Ferrand | Clermont-Ferrand | France | 63003 |
Sponsors and Collaborators
- University Hospital, Clermont-Ferrand
- Edwards Lifesciences
- Abbott Medical Devices
- Sorin group, Italy
- Ministry of Health, France
Investigators
- Principal Investigator: Kasra AZARNOUSH, MD, PhD, University Hospital, Clermont-Ferrand
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHU-0109