Status:
NOT_YET_RECRUITING
Blinded Randomized Controlled Trial of Artificial Intelligence Guided Detection of Intracardiac Thrombus
Lead Sponsor:
Shanghai Chest Hospital
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-90 years
Phase:
NA
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06206187
Start Date
January 5 2024
End Date
December 31 2025
Last Update
January 16 2024
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030