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

NCT06206187

UnknownNA

Sponsor: Shanghai Chest Hospital

Conditions: Atrial Fibrillation

Interventions: Automated detection of the intracardiac thrombus through deep learning, Electrophysiologist judgment of the intracardiac thrombus

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 90 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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, Shanghai Municipality, China