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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
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease Intervention/treatment
Atrial Fibrillation Other: No interventional study

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: No interventional study
    No interventional study


Primary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Locations
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France
Professeur Patrice Guerin Recruiting
Nantes, France, 44093
Contact: Patrice Guerin, MD0    0240165592    patrice.guerin@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03961490     History of Changes
Other Study ID Numbers: RC17_0069
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes