Blinded Randomized Controlled Trial of Artificial Intelligence Guided Detection of Intracardiac Thrombus

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation
• Interventions: Other: Electrophysiologist judgment of the intracardiac thrombus; Other: Automated detection of the intracardiac thrombus through deep learning

• Registration Number: NCT06206187
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

To determine whether an integrated AI decision support can save time and improve the accuracy of detection of intracardiac thrombus, the investigators are conducting a blinded, randomized controlled study of AI-guided detection of intracardiac thrombus to electrophysiologist judgment in preliminary readings of echocardiograms.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Last Update Submitted: 2024-01-04
• Study Start: 2024-01-05
• Study First Posted: 2024-01-16
• Last Update Posted: 2024-01-16
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

1. Aged 18-80 years.
2. Willing to sign informed consent.
3. Patients diagnosed with atrial fibrillation Paroxysmal AF and Persistent AF according to the latest clinical guidelines

Exclusion Criteria

1. End-stage disease with a mean life expectancy less than 1 year
2. New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction less than 30%
3. Previous surgical or catheter ablation for AF
4. Bradycardia and presence of implanted ICD
5. Uncontrolled hypertension: Systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) > 110 mmHg
6. Patients with Cardiovascular events including acute myocardial infarction, any PCI, valvular cardiac surgical, or percutaneous procedure within the past 3 months
7. Women of childbearing potential who are, or plan to become, pregnant during the time of the study
8. Have been enrolled in an investigational study evaluating devices or drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrophysiologist judgment	Electrophysiologist judgment of the intracardiac thrombus	-
Artificial Intelligence Detection	Automated detection of the intracardiac thrombus through deep learning	-

Primary Outcome Measures

Name	Time	Method
Degree of change from initial (AI vs EP doctor) assessment to final cardiologist assessment	10 Minutes

Secondary Outcome Measures

Name	Time	Method
Perioperative adverse event rates	10 Minutes

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, 上海市, China