Clinical trial: Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI (NCT01672268)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 23-year-old man comes to the emergency department following an episode of syncope.  He was working out when he felt dizzy and passed out without head injury.  He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions.  The patient does not use tobacco, alcohol, or illicit drugs.  His father died suddenly at age 35.  Vital signs are within normal limits.  On physical examination, the patient has a harsh systolic murmur.  The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy.

Patient description (patient's own words): I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average.

Does the patient match the trial criteria? Contradiction