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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06169332
Other study ID # LATE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 13, 2010
Est. completion date March 25, 2013

Study information

Verified date December 2023
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 260
Est. completion date March 25, 2013
Est. primary completion date March 25, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac computed tomography for the staging of patients with intraauricular thrombosis. evaluation of the diagnostic accuracy of cardio CT in the diagnosis of intraauricular thrombosis in patients candidates for atrial fibrillation ablation. 3 years
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