ICE Detector-RCT: Blinded, Randomized Controlled Trial of Electrophysiologist vs. Artificial Intelligence Detection of Intracardiac Thrombus

Shanghai Chest Hospital1 site in 1 country1,500 target enrollmentJanuary 5, 2024

ConditionsAtrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Shanghai Chest Hospital
Enrollment: 1500
Locations: 1
Primary Endpoint: Degree of change from initial (AI vs EP doctor) assessment to final cardiologist assessment
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 5, 2024

End Date

December 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Chest Hospital

Responsible Party

Principal Investigator

Xu Liu

professor

Shanghai Chest Hospital

Eligibility Criteria

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.