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

NCT06169332 | Completed

• 1 other identifier: LATE
• Study Type: observational
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Computed Tomography

Experimental computed tomography protocol: a few minutes after the administration of the contrast medium at a very low dose of radiation performed only in those patients in whom there is a doubt of thrombosis in the early arterial phase.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in whom there is a doubt of thrombosis in the early arterial phase.

You may not qualify if:

• \< 18 years patients

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 13, 2023
• Study Start: December 13, 2010
• Primary Completion: March 25, 2013
• Study Completion: March 25, 2013
• Last Updated: December 13, 2023

Record last verified: 2023-12