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

NCT06206187 | Unknown DMC

• 1 other identifier: ICE Detector-RCT
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

  10 Minutes

Secondary Outcomes (1)

• Perioperative adverse event rates

  10 Minutes

Study Arms (2)

Electrophysiologist judgment

ACTIVE COMPARATOR

Other: Electrophysiologist judgment of the intracardiac thrombus

Artificial Intelligence Detection

EXPERIMENTAL

Other: Automated detection of the intracardiac thrombus through deep learning

Interventions

Automated detection of the intracardiac thrombus through deep learning OTHER

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

Artificial Intelligence Detection

Electrophysiologist judgment of the intracardiac thrombus OTHER

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

Electrophysiologist judgment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shaohui Wu, PHD

CONTACT

15821960839; wushaohui18@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: January 5, 2024
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)