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

N/AUnknownNCT06206187

Shanghai Chest Hospital1,500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

1,500

Conditions

Atrial Fibrillation

Interventions

Automated detection of the intracardiac thrombus through deep learningOTHER

A deep learning model will identify the intracardiac thrombus. The AI model will produce an assessment of intracardiac thrombus using video based features.

Electrophysiologist judgment of the intracardiac thrombusOTHER

Cardiac electrophysiologists use their own experience to determine whether there is intracardiac thrombus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Degree of change from initial (AI vs EP doctor) assessment to final cardiologist assessment

Time frame: 10 Minutes

Secondary Outcomes

Perioperative adverse event rates

Time frame: 10 Minutes

Central Contacts

Shaohui Wu, PHD

CONTACT

15821960839 wushaohui18@163.com

Data from ClinicalTrials.gov

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