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| Name | Class |
|---|---|
| Shanghai Shidong Hospital, Yangpu District | UNKNOWN |
| Eastern Hepatobiliary Surgery Hospital | OTHER |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the "Floating Lotus" Sign | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Independent Predictors of the "Floating Lotus" Sign | Preoperative baseline | |
| Determinants of Left Atrial Appendage (LAA) Emptying Velocity | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital) | Shanghai | Shanghai Municipality | 200433 | China | ||
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.
Available starting 12 months after publication of the primary results, for a duration of 12 months.
Access granted only to qualified researchers upon reasonable request. Only de identified participant-leveldata will be shared. Requests are subject to sponsor approval.
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| Shanghai Shidong Hospital, Yangpu District |
| Shanghai |
| Shanghai Municipality |
| 200438 |
| China |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007053 | Ice |
| ID | Term |
|---|---|
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D014887 | Weather |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
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