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Research on Post-Stroke Anticoagulation Strategies for Atrial Fibrillation Based on Left Atrial Appendage Flow Velocity Measured by Intracardiac Echocardiography (ICE)

Research on Post-Stroke Anticoagulation Strategies for Atrial Fibrillation Based on Left Atrial Appendage Flow Velocity Measured by Intracardiac Echocardiography (ICE)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07439731
Enrollment
172
Registered
2026-02-27
Start date
2024-01-01
Completion date
2024-12-31
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial fibrillation, Catheter rotation maneuver, Pseudo-thrombus, Intracardiac echocardiography

Brief summary

1. Study Purpose The primary aim of this research was to systematically describe and characterize a novel, thrombus-mimicking artifact observed during Intracardiac Echocardiography (ICE), termed the "Floating Lotus" sign. The study sought to define its imaging features, determine its prevalence, and identify the clinical factors that predict its occurrence. This was driven by the clinical need to prevent the misdiagnosis of this pseudo-thrombus as a true Left Atrial Appendage (LAA) thrombus, which could lead to unnecessary procedure cancellations or anticoagulation changes. 2. Study Population The study population consisted of 172 consecutive patients with non-valvular atrial fibrillation (AF) who underwent ICE-guided catheter ablation and/or left atrial appendage occlusion (LAAO) between January and December 2024 across three tertiary medical centers. Patients with confirmed intracardiac thrombus, significant valvular heart disease, or prior cardiac surgery were excluded. 3. Key Research Focus The key research focus was a multi-faceted investigation of the "Floating Lotus" sign: Incidence and Imaging Characterization: To quantify how common this sign is (found in 27.9% of patients) and meticulously describe its dynamic sonographic appearance-a mobile, echogenic mass within an anechoic space (pericardial effusion) that merges with the LAA wall upon catheter rotation. Identification of Clinical Predictors: To analyze which patient factors are associated with the sign. The study identified heart failure (LVEF \<55%) as the sole independent predictor through multivariable analysis. Clinical Correlation and Differentiation: To examine the sign's association with other clinical parameters (e.g., recent stroke, larger left atrial diameter) and emphasize the critical imaging maneuver (catheter rotation) that differentiates it from a true LAA thrombus, thereby highlighting its direct implications for procedural safety and decision-making.

Interventions

DIAGNOSTIC_TESTIntracardiac Echocardiography (ICE) for Differential Diagnosis

The core of this procedure is to perform a characteristic catheter operation on the basis of routine ICE scanning of the left atrial appendage: when an unclear, movable, chaotic echogenic mass (suspected thrombus) is observed in the standard plane, the operator needs to slowly and continuously rotate the ICE catheter clockwise. This dynamic maneuver aims to induce morphological changes in the echogenic mass, observe whether it merges with the left atrial appendage wall and reveals the underlying pectinate muscle structure, thereby confirming it as a pericardial effusion-related floating artifact (i.e., the 'Floating Lotus' sign), rather than a true intracavitary thrombus.

Sponsors

Changhai Hospital
Lead SponsorOTHER
Shanghai Shidong Hospital, Yangpu District
CollaboratorUNKNOWN
Eastern Hepatobiliary Surgery Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with a confirmed diagnosis of non-valvular atrial fibrillation (paroxysmal or persistent). * Completion of complete intracardiac echocardiography (ICE) imaging during the catheter ablation or left atrial appendage occlusion (LAAO) procedure.

Exclusion criteria

* Confirmed intracardiac thrombus on pre-procedural transesophageal echocardiography (TEE) or left atrial computed tomography angiography (CTA). * Significant valvular heart disease (moderate or severe stenosis/regurgitation) or a history of cardiac surgery. * Incomplete clinical or imaging data.

Design outcomes

Primary

MeasureTime frame
Incidence of the "Floating Lotus" SignIntraoperative

Secondary

MeasureTime frame
Independent Predictors of the "Floating Lotus" SignPreoperative baseline
Determinants of Left Atrial Appendage (LAA) Emptying VelocityIntraoperative

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026