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

Atrial Fibrillation Clinical Trial

Official title:

Contribution of Image Fusion in Percutaneous Left Atrial Occlusion Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961490
• Other study ID #: RC17_0069
• Status: Completed
• Start date: June 9, 2017
• Est. completion date: May 15, 2018

Study information

• Verified date: April 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• No interventional study
No interventional study

Locations

Country	Name	City	State
France	Professeur Patrice Guerin	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the contribution of image fusion to reduce patient irradiation with measurement of the amount of irradiation of the procedure	the cumulative Air KERMA in milligray (mGy)	3 years
Primary	evaluate the contribution of image fusion to reduce patient irradiation with measurement of the amount of irradiation of the procedure	the surface dose product (PDS) in centigray centimetres squared (cGy.cm²)	3 years