Contribution of Image Fusion in Percutaneous Left Atrial Occlusion procédures (Fusion Image)
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|ClinicalTrials.gov Identifier: NCT03961490|
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
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.
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Other: No interventional study|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Contribution of Image Fusion in Percutaneous Left Atrial Occlusion Procedures|
|Actual Study Start Date :||June 9, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
- Other: No interventional study
No interventional study
- evaluate the contribution of image fusion to reduce patient irradiation with measurement of the amount of irradiation of the procedure [ Time Frame: 3 years ]the cumulative Air KERMA in milligray (mGy)
- evaluate the contribution of image fusion to reduce patient irradiation with measurement of the amount of irradiation of the procedure [ Time Frame: 3 years ]the surface dose product (PDS) in centigray centimetres squared (cGy.cm²)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961490
|Professeur Patrice Guerin||Recruiting|
|Nantes, France, 44093|
|Contact: Patrice Guerin, MD0 0240165592 email@example.com|