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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06169332
• Other study ID #: LATE
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Thrombosis

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