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Artificial Intelligence-Assisted Intracardiac Echocardiography System for Left Atrial Appendage Structure Evaluation and Hemodynamic Analysis

Artificial Intelligence-Assisted Intracardiac Echocardiography System for Left Atrial Appendage Structure Evaluation and Hemodynamic Analysis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400094678
Enrollment
Unknown
Registered
2024-12-26
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation

Interventions

Phase Two: Experimental Group:Using the ICE (Intracardiac Echocardiography) imaging data of patients, apply AI technology for processing. Specific steps include annotation, extraction, learning, and v
Phase Two: Control Group:Using real data recorded during the actual clinical follow-up of patients, calculate the frequency of thrombotic events and AF recurrence.
Phase 1: AI Learning Set Queue Research:Prospectively collect data from 500 patients undergoing non-valvular atrial fibrillation radiofrequency ablation and/or left atrial appendage occlusion under th

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: percutaneous left atrial appendage occlusion: (1) Patients with non-valvular persistent AF; (2) Age>=18 years; (3) CHA2 DS2-VASc score >=2 points; (4) Has-Bled score>=3 points; (5) There are contraindications to the use of warfarin or are unwilling to take warfarin for a long time. radiofrequency ablation: (1) Age>=18 years and <=80 years; (2) Patients diagnosed with non-valvular atrial fibrillation who are to be treated with radiofrequency ablation; (3) The subject understands the purpose and process of the study and is willing to participate in the study, and signs the informed document.

Exclusion criteria

Exclusion criteria: **Percutaneous Left Atrial Appendage Occlusion Procedure:** 1. Atrial fibrillation (AF) complicated by valvular heart disease; 2. Presence of suspected or confirmed thrombus in the left atrium or left atrial appendage detected by pre-procedural transesophageal echocardiography (TEE); 3. Severe heart failure and significant hepatic or renal dysfunction; 4. Acute myocardial infarction; 5. Stroke within the past month. **Radiofrequency Ablation:** 1. Presence of left atrial appendage thrombus detected by pre-procedural transesophageal echocardiography (TEE); 2. Left atrial anteroposterior diameter >60 mm as assessed by pre-procedural transthoracic echocardiography; 3. Presence of structural heart disease, such as atrial septal defect, ventricular septal defect, Tetralogy of Fallot, or transposition of the great arteries; 4. Postoperative structural heart disease following surgical or interventional procedures, such as atrial septal defect repair or mitral valve replacement; 5. Coagulation dysfunction; 6. Recent active bleeding; 7. Refusal to undergo intracardiac echocardiography catheterization or transesophageal echocardiography; 8. Other conditions deemed unsuitable for interventional treatment by researchers, such as fever, uncontrolled heart failure, recent myocardial infarction, stroke or bleeding, or advanced-stage malignancies.

Design outcomes

Primary

MeasureTime frame
Left atrial appendage blood flow velocity;Left atrial appendage structure;

Secondary

MeasureTime frame
Spontaneous contrast in the left atrial appendage;

Countries

China

Contacts

Public ContactShuyan Li

The First Hospital of Jilin University

Lixb94@163.com+86 135 9605 2348

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026