Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI

Last updated: November 24, 2014
Sponsor: University Hospital, Grenoble
Overall Status: Completed

Phase

3

Condition

Heart Defect

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT01672268
2011-A001113-38
2011-A001113-38
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient with a symptomatic severe aortic stenosis with a too high risk of surgicalvalvular replacement. This patient will be selected for a TAVI. In this study, we onlyrandomized 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 surgeryby a heart team

  • Severe Aortic stenosis with symptoms like dyspnea, heartache, syncope, heart failure

Exclusion

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.

Study Design

Total Participants: 70
Study Start date:
February 01, 2012
Estimated Completion Date:
November 30, 2014

Study 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.

Connect with a study center

  • University Hospital

    Grenoble, 38700
    France

    Site Not Available

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