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

NCT07439731 | Completed

• 1 other identifier: 2024XC108
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 2

Brief Summary

1. 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. 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. 3.Key Research Focus

Conditions

Atrial Fibrillation (AF)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of the "Floating Lotus" Sign

  Intraoperative

Secondary Outcomes (2)

• Independent Predictors of the "Floating Lotus" Sign

  Preoperative baseline

• Determinants of Left Atrial Appendage (LAA) Emptying Velocity

  Intraoperative

Interventions

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.

Also known as: Catheter Rotation Maneuver for Pseudo-Thrombus Differentiation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead
• Shanghai Shidong Hospital, Yangpu District: collaborator
• Eastern Hepatobiliary Surgery Hospital: collaborator

Study Sites (2)

The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)

Shanghai, Shanghai Municipality, 200433, China

Location

Shanghai Shidong Hospital, Yangpu District

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Ice

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available starting 12 months after publication of the primary results, for a duration of 12 months.
• 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.

Locations

CN (2)