Comparison Between Three Types of Stented Pericardial Aortic Valves

This study is currently recruiting participants.
Verified September 2013 by University Hospital, Clermont-Ferrand
Sponsor:
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: September 2, 2013
Last verified: September 2013

December 20, 2011
September 2, 2013
March 2012
December 2013   (final data collection date for primary outcome measure)
measurement of postoperative trans-valvular mean gradient by echocardiography [ Time Frame: after 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01522352 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Aortic Valve Replacement
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)
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)
Intervention: Procedure: Aortic valve replacement by bioprosthesis
Azarnoush K, Pereira B, Dualé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
165
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr
France
 
NCT01522352
CHU-0109
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
  • Edwards Lifesciences
  • St. Jude Medical
  • Sorin group, Italy
  • Ministry of Health, France
Principal Investigator: Kasra AZARNOUSH, MD, PhD University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP