UnknownNot Applicable

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

China1,500 participantsStarted 2024-01-05

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

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

What they're measuring

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

Timeframe: 10 Minutes

Trial details

NCT IDNCT06206187

SponsorShanghai Chest Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

Contact for this trial

Shaohui Wu, PHD

15821960839 wushaohui18@163.com

View on ClinicalTrials.gov More Atrial Fibrillation trials