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

NCT ID: NCT03961490

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-09
• Study Completion Date: 2018-05-15

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

No interventional study

No interventional study

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Professeur Patrice Guerin

Nantes, , France

Countries

France

Other Identifiers

RC17_0069

Identifier Type: -

Identifier Source: org_study_id