Comparison Between Three Types of Stented Pericardial Aortic Valves
This study is not yet open for participant recruitment.
Verified January 2012 by University Hospital, Clermont-Ferrand
Sponsor:
University Hospital, Clermont-Ferrand
Collaborators:
Edwards Lifesciences
St. Jude Medical
Sorin group, Italy
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01522352
First received: December 20, 2011
Last updated: January 27, 2012
Last verified: January 2012
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Purpose
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 | Intervention |
|---|---|
|
Aortic Valve Replacement |
Procedure: Aortic valve replacement by bioprosthesis |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Comparison of Short and Mid-term Hemodynamic Performance Between Three Types of Stented Pericardial Aortic Valves |
Further study details as provided by University Hospital, Clermont-Ferrand:
Primary Outcome Measures:
- measurement of postoperative trans-valvular mean gradient by echocardiography [ Time Frame: after 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Comparison between aortic annulus diameter measurement by preoperative CT angiography, transthoracic echocardiography and the aortic annulus' surgical size [ Time Frame: at six months ] [ Designated as safety issue: Yes ]
- Comparison between the aortic annulus measurement and the implanted bioprosthesis size [ Time Frame: at six months ] [ Designated as safety issue: Yes ]
- Surgical outcome at hospital [ Time Frame: at 6 months. ] [ Designated as safety issue: Yes ]
- Postoperative trans-valvular mean gradient by echocardiography [ Time Frame: at six months. ] [ Designated as safety issue: Yes ]
- Comparison of the transthoracic echocardiography estimated postoperative aortic surfaces [ Time Frame: at six months. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 165 |
| Study Start Date: | February 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
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| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522352
Contacts
| Contact: Patrick LACARIN | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
Locations
| France | |
| CHU Clermont-Ferrand | Not yet recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr | |
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Edwards Lifesciences
St. Jude Medical
Sorin group, Italy
Ministry of Health, France
Investigators
| Principal Investigator: | Kasra AZARNOUSH, MD, PhD | University Hospital, Clermont-Ferrand |
More Information
No publications provided
| Responsible Party: | University Hospital, Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT01522352 History of Changes |
| Other Study ID Numbers: | CHU-0109 |
| Study First Received: | December 20, 2011 |
| Last Updated: | January 27, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Clermont-Ferrand:
|
Bioprosthesis, aortic valve replacement Magna Ease Mitroflow Trifecta |
ClinicalTrials.gov processed this record on May 19, 2013