Brief Title
Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI
Official Title
Interest of Cardiac Computed Tomography (CT) to Optimize and Improve the Procedure of Transcatheter Aortic Valve Implantation (TAVI)
Brief Summary
This is a pilot prospective, comparative, monocentric, randomized study with 2 groups. People with a severe aortic stenosis and a high risk of surgery are referred to a Trans catheter aortic valve implantation (TAVI).
Detailed Description
The proposed study is to show the interest of a cardiac computed tomography (CT) to improve the TAVI procedure. The Cardiac computed tomography (CT) shows the exact geometry of the aortic annulus and help the physician to find the right position of the prosthesis during the procedure. The hypothesis is that performing a cardiac CT before the TAVI could reduce the number of vascular peripheral complication, the number of stroke and can minimize the aortic regurgitation during the follow up.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Composite end point
Secondary Outcome
To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
Condition
Aortic Stenosis
Intervention
cardiac computed tomography
Study Arms / Comparison Groups
Standard TAVI procedure
Description: Patients without Cardiac CT measures before TAVI
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
70
Start Date
February 2012
Completion Date
November 2014
Primary Completion Date
November 2012
Eligibility Criteria
Inclusion Criteria: - Patient with a symptomatic severe aortic stenosis with a too high risk of surgical valvular replacement. This patient will be selected for a TAVI. In this study, we only randomized patient for a TAVI with an Edwards prosthesis - male or female patient, older than eighteen years old - who have given their written consent - who are affiliated to the French social security system - which has a too high risk of surgical valvular replacement (EuroSCORE logistic > 20% or Society of Thoracic Surgeons Score > 10, or contre indicated to a cardiac surgery by a heart team - Severe Aortic stenosis with symptoms like dyspnea, heartache, syncope, heart failure Exclusion Criteria: - Patient who can't give his written consent because of his physical or mental status - Adult patient protect by law (article L1121-8), - Person deprived of liberty (article L1121-8), - Pregnant women - Patient in terminal phase of illness, - Terminal kidney failure - Allergy to iodine - bicuspids ou unicuspid aortic, - Diameter of the left ventricular outflow tract < 18mm or > 25mm, - Diameter of the femoral artery < 7mm, tortuosity or calcifications - Septal hypertrophy - Apical thrombosis.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Gilles MD BARONE ROCHETTE, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01672268
Organization ID
2011-A001113-38
Secondary IDs
2011-A001113-38
Responsible Party
Sponsor
Study Sponsor
University Hospital, Grenoble
Study Sponsor
Gilles MD BARONE ROCHETTE, Principal Investigator, University Hospital, Grenoble
Verification Date
April 2012