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Completed

NCT Number: NCT07439731

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Shidong Hospital, Yangpu District, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Intracardiac Echocardiography (ICE) for Differential Diagnosis

Diagnostic Test

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.

Other names: Catheter Rotation Maneuver for Pseudo-Thrombus Differentiation

Primary outcomes

  1. Incidence of the "Floating Lotus" Sign

    Time frame: Intraoperative

Secondary outcomes

  1. Independent Predictors of the "Floating Lotus" Sign

    Time frame: Preoperative baseline

  2. Determinants of Left Atrial Appendage (LAA) Emptying Velocity

    Time frame: Intraoperative

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • Eastern Hepatobiliary Surgery Hospital
  • Shanghai Shidong Hospital, Yangpu District

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

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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