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

February 23, 2026 updated by: Changhai Hospital
  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

172

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
      • Shanghai, Shanghai Municipality, China, 200438
        • Shanghai Shidong Hospital, Yangpu District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population was derived from patients with atrial fibrillation who consecutively underwent intracardiac echocardiography (ICE)-guided catheter ablation and/or left atrial appendage occlusion (LAAO) between January and December 2024 at three tertiary medical centers in China.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of the "Floating Lotus" Sign
Time Frame: Intraoperative
Intraoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Independent Predictors of the "Floating Lotus" Sign
Time Frame: Preoperative baseline
Preoperative baseline
Determinants of Left Atrial Appendage (LAA) Emptying Velocity
Time Frame: Intraoperative
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

Eastern Hepatobiliary Surgery Hospital
Shanghai Shidong Hospital, Yangpu District

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024XC108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share fully de-identified individual participant data (IPD) that underlie the results reported in the primary publication of this study. This includes:

Baseline demographic and clinical characteristics; Procedural echocardiographic parameters ; These data will be made available upon reasonable request to researchers whose proposed use has been approved by an independent review committee for legitimate scientific purposes. Data will be shared after the publication of the primary results, typically within 12 months. Data access requires a signed data use agreement to ensure compliance with ethical and privacy regulations.

IPD Sharing Time Frame

Available starting 12 months after publication of the primary results, for a duration of 12 months.

IPD Sharing Access Criteria

Access granted only to qualified researchers upon reasonable request. Only de identified participant-leveldata will be shared. Requests are subject to sponsor approval.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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