Comparison Between Three Types of Stented Pericardial Aortic Valves

This study is currently recruiting participants. (see Contacts and Locations)
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
  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: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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 by University Hospital, Clermont-Ferrand

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: September 2, 2013
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 August 19, 2014