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

Contribution of Image Fusion in Percutaneous Left Atrial Occlusion Procedures

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: No interventional study

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Professeur Patrice Guerin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This is an elderly population with multiple co-morbidities (hypertension, renal failure, diabetes, etc.), with a major thromboembolic and haemorrhagic risk, and with a formal contraindication to anticoagulant therapy.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2017
• Primary Completion (Actual): May 15, 2018
• Study Completion (Actual): May 15, 2018

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: RC17_0069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No