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OpenTrials
Completed

NCT Number: NCT03961490

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Professeur Patrice Guerin

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Interventional study

Other

No interventional study

Primary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Contribution of Image Fusion in Percutaneous Left Atrial Occlusion Procedures

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 23, 2019
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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