Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI (CT-TAVI)

Interest of Cardiac Computed Tomography (CT) to Optimize and Improve the Procedure of Transcatheter Aortic Valve Implantation (TAVI)

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).

Study Overview

• Status: Completed
• Conditions: Aortic Stenosis
• Intervention / Treatment: Other: cardiac computed tomography

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38700
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard TAVI procedure; Patients without Cardiac CT measures before TAVI	Other: cardiac computed tomography; cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy; Other Names: Transcatheter Aortic Valve Implantation
Experimental: Cardiac CT scan before TAVI procedure; patients with cardiac CT measures before TAVI	Other: cardiac computed tomography; cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy; Other Names: Transcatheter Aortic Valve Implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite end point	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	participants will be followed for the duration of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare results of transthoracic / transoesophageal echocardiography and cardiac CT	• Size of the aortic annulus/ diameter and area	inclusion visit
To compare results of transthoracic / transoesophageal echocardiography and cardiac CT	• Left ventricular outflow tract, anatomy of the aortic roots	inclusion visit
To compare results of transthoracic / transoesophageal echocardiography and cardiac CT	• Left ventricular function, size, volume	inclusion visit

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Gilles MD BARONE ROCHETTE, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: August 21, 2012
• First Posted (Estimate): August 24, 2012

Study Record Updates

• Last Update Posted (Estimate): November 25, 2014
• Last Update Submitted That Met QC Criteria: November 24, 2014
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: cardiac computed tomography; safety and efficacy; Transcatheter Aortic Valve Implantation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 2011-A001113-38 (Other Identifier: 2011-A001113-38)