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NCT07439731Completed

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

Source: ClinicalTrials.gov · Last updated 27 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
172 (actual)
First submitted
23 Feb 2026
Start date
1 Jan 2024
Primary completion date
31 Dec 2024
Lead sponsor
Changhai Hospital
NCT number
NCT07439731

What you commit to

  • Study type: Observational
  • Participants enrolled: 172
  • From 1 Jan 2024 to the primary completion date, 31 Dec 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Significant valvular heart disease (moderate or severe stenosis/regurgitation) or a history of cardiac surgery.

Other

  • Confirmed intracardiac thrombus on pre-procedural transesophageal echocardiography (TEE) or left atrial computed tomography angiography (CTA).
  • Incomplete clinical or imaging data.

Who the study is looking for

  • 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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Shanghai Shidong Hospital, Yangpu District
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.