Contribution of Image Fusion in Percutaneous Left Atrial Occlusion procédures (Fusion Image)

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT03961490
• Lead Sponsor: Nantes University Hospital

Brief Summary

Atrial fibrillation is the most common rhythm disorder, affecting 2 to 3 percent of the population. One of the major complications is the occurrence of thromboembolic events, the thromboembolic risk can be predicted by the ChadsVasc score. Anticoagulant treatment is therefore almost always indicated, however, in view of the target population, anticoagulant treatment is sometimes contraindicated, justifying the appearance of alternative treatment such as occlusion of the left auricle by surgical or percutaneous means, with the placement of a prosthesis in the left auricle.

Image fusion is a new imaging technique aimed at improving the spatial view of 2D images (made during a catheterization session) by repositioning in real time a 3D model obtained by reconstruction from scanner images of the structure of interest. Once the model has been redesigned, it follows all the consequences that the hemodynamicist wants to take and thus guides the gesture as well as possible.

The purpose of this project is to evaluate the contribution of image fusion to per cutaneous occlusion procedures of the left atrium. This contribution will be evaluated by comparing the procedure time, the irradiation time, the amount of contrast material used between the procedures performed with the image fusion technique and without this new technique.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-09
• Primary Completion: 2018-05-15
• Study Completion: 2018-05-15
• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-23
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Major patient
• Patient with a collegially selected indication of FAG
• Patient willing to participate in the study

Exclusion Criteria

• Minors, adults under guardianship and protected persons
• Presence of contraindications to the procedure, including the presence of a thrombus in the left atrium
• Procedure combined with another percutaneous gesture at the same time

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evaluate the contribution of image fusion to reduce patient irradiation with measurement of the amount of irradiation of the procedure	3 years	the surface dose product (PDS) in centigray centimetres squared (cGy.cm²)

Trial Locations

Locations (1)

Professeur Patrice Guerin; 🇫🇷 Nantes, France