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

Phase 3

Completed

• Conditions: Aortic Stenosis
• Interventions: Other: cardiac computed tomography

• Registration Number: NCT01672268
• Lead Sponsor: University Hospital, Grenoble

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 Timeline

• Study Start: 2012-02
• Status Verified: 2012-04
• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-24
• Primary Completion: 2012-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-24
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard TAVI procedure	cardiac computed tomography	Patients without Cardiac CT measures before TAVI
Cardiac CT scan before TAVI procedure	cardiac computed tomography	patients with cardiac CT measures before TAVI

Primary Outcome Measures

Name	Time	Method
Composite end point	participants will be followed for the duration of 1 year	Composite end point with Stroke (symptoms and CT or MRI), Vascular complications (hematoma with the need of transfusion, dissection of artery/ legs ischemia), and Aortic regurgitation after the procedure, evaluated by transthoracic echocardiography

Secondary Outcome Measures

Name	Time	Method
To compare results of transthoracic / transoesophageal echocardiography and cardiac CT	inclusion visit	• Left ventricular function, size, volume

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Grenoble, France