Atrial Fibrillation (AF)NCT07439731
Research on Post-Stroke Anticoagulation Strategies for Atrial Fibrillation Based on Left Atrial Appendage Flow Velocity Measured by Intracardiac Echocardiography (ICE)
An observational study of Atrial Fibrillation (AF), run by Changhai Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Intracardiac Echocardiography (ICE) for Differential Diagnosis
- How many people
- 172 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
Shanghai, Shanghai Municipality, 200433
Shanghai Shidong Hospital, Yangpu District
Shanghai, Shanghai Municipality, 200438
About this study
- 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.
- 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.
- Key Research Focus
The key research focus was a multi-faceted investigation of the "Floating Lotus" sign:
Read more
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.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Intracardiac Echocardiography (ICE) for Differential Diagnosis
- Keywords
- Atrial fibrillation, Catheter rotation maneuver, Pseudo-thrombus, Intracardiac echocardiography
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracardiac Echocardiography (ICE) for Differential DiagnosisDiagnostic test
Also called Catheter Rotation Maneuver for Pseudo-Thrombus Differentiation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the "Floating Lotus" Sign
Measured: Intraoperative
Secondary outcomes (2)
Independent Predictors of the "Floating Lotus" Sign
Measured: Preoperative baseline
Determinants of Left Atrial Appendage (LAA) Emptying Velocity
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Shidong Hospital, Yangpu District, Eastern Hepatobiliary Surgery Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439731
- Sponsor's protocol ID
- 2024XC108
- Status last verified
- Dec 2025
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Post-Stroke Anticoagulation Strategies for Atrial Fibrillation Based on Left Atrial Appendage Flow Velocity Measured by Intracardiac Echocardiography (ICE)
- ClinicalTrials.gov ID
- NCT07439731
- Acronym / sponsor ID
- 2024XC108
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial fibrillation, Catheter rotation maneuver, Pseudo-thrombus, Intracardiac echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Shanghai Shidong Hospital, Yangpu District, Eastern Hepatobiliary Surgery Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracardiac Echocardiography (ICE) for Differential DiagnosisAlso: Catheter Rotation Maneuver for Pseudo-Thrombus DifferentiationThe 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. | Diagnostic test | – |
Primary outcome
Incidence of the "Floating Lotus" Sign
Time frame: Intraoperative
2 secondary outcomes
Independent Predictors of the "Floating Lotus" Sign
Time frame: Preoperative baseline
Determinants of Left Atrial Appendage (LAA) Emptying Velocity
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by Changhai Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the "Floating Lotus" Sign (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.