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

Primary Purpose

Aortic Stenosis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
cardiac computed tomography
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard TAVI procedure

Cardiac CT scan before TAVI procedure

Arm Description

Patients without Cardiac CT measures before TAVI

patients with cardiac CT measures before TAVI

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2012
Last Updated
November 24, 2014
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT01672268
Brief Title
Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI
Acronym
CT-TAVI
Official Title
Interest of Cardiac Computed Tomography (CT) to Optimize and Improve the Procedure of Transcatheter Aortic Valve Implantation (TAVI)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis
Keywords
cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard TAVI procedure
Arm Type
Active Comparator
Arm Description
Patients without Cardiac CT measures before TAVI
Arm Title
Cardiac CT scan before TAVI procedure
Arm Type
Experimental
Arm Description
patients with cardiac CT measures before TAVI
Intervention Type
Other
Intervention Name(s)
cardiac computed tomography
Other Intervention Name(s)
Transcatheter Aortic Valve Implantation
Intervention Description
cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy
Primary Outcome Measure Information:
Title
Composite end point
Description
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
Time Frame
participants will be followed for the duration of 1 year
Secondary Outcome Measure Information:
Title
To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
Description
• Size of the aortic annulus/ diameter and area
Time Frame
inclusion visit
Title
To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
Description
• Left ventricular outflow tract, anatomy of the aortic roots
Time Frame
inclusion visit
Title
To compare results of transthoracic / transoesophageal echocardiography and cardiac CT
Description
• Left ventricular function, size, volume
Time Frame
inclusion visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles MD BARONE ROCHETTE
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Grenoble
ZIP/Postal Code
38700
Country
France

12. IPD Sharing Statement

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

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