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

NCT03961490 | Completed

• 1 other identifier: RC17_0069
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

No interventional study OTHER

No interventional study

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Professeur Patrice Guerin

Nantes, 44093, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: June 9, 2017
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)