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

Aortic Stenosis Clinical Trial

— CT-TAVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672268
• Other study ID #: 2011-A001113-38
• Secondary ID: 2011-A001113-38
• Status: Completed
• Phase: Phase 3
• First received: April 18, 2012
• Last updated: November 24, 2014
• Start date: February 2012
• Est. completion date: November 2014

Study information

• Verified date: April 2012
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2014
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis

Intervention

Other:
• cardiac computed tomography
cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy

Locations

Country	Name	City	State
France	University Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To compare results of transthoracic / transoesophageal echocardiography and cardiac CT	• Size of the aortic annulus/ diameter and area	inclusion visit	No
Secondary	To compare results of transthoracic / transoesophageal echocardiography and cardiac CT	• Left ventricular outflow tract, anatomy of the aortic roots	inclusion visit	No
Secondary	To compare results of transthoracic / transoesophageal echocardiography and cardiac CT	• Left ventricular function, size, volume	inclusion visit	No