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OpenTrials
Completed

NCT Number: NCT06169332

Multidetector CT Left Appendage Atrial Thrombosis Exclusion in Patients With Atrial Fibrillation

The aim of the LATE (multidetector CT Lefi Appendage atrial Thrombosis Exclusion in patients with atrial fibrillation) study is to evaluate the diagnostic accuracy of cardiac Computed Tomography (TC) with 64 detectors and double acquisition phase in candidate patients ablation of atrial fibrillation (AF) with the Navx (or Carto) technique, using trans-esophageal ultrasound (TEE) as the standard reference.

This study is based on the use of an experimental protocol in cardiac TC which involves, in addition to the acquisition of an early arterial phase (standard protocol routinely performed in all patients), the execution of a possible late phase at a very low dose of radiation (experimental protocol) aimed at increasing the accuracy of the method in the diagnosis in patients with AF. The LATE study aims to demonstrate the high diagnostic accuracy of dual acquisition phase cardiac TC in the diagnosis of intraauricular thrombosis by comparing it with reference standard; in light of this result, cardiac TC could constitute a single non-invasive diagnostic tool in the future for the global evaluation of both atrial anatomy and endoawicular thrombosis with a clear improvement in patient management both in clinical and economic terms.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients candidates for cardiac TC and transesophageal ultrasound examination for the evaluation of cardiac anatomy and for the exclusion of intra-auricular thrombosis.

Exclusion criteria

  • < 18 years patients

Treatment and study plan

Primary outcomes

  1. Cardiac computed tomography for the staging of patients with intraauricular thrombosis.

    Time frame: 3 years

    evaluation of the diagnostic accuracy of cardio CT in the diagnosis of intraauricular thrombosis in patients candidates for atrial fibrillation ablation.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Dec 13, 2023
Registry last updated
Dec 13, 2023

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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