Skip to content

Establishment of a dynamic assessment system for reducing the risk of cardioembolic stroke following left atrial appendage closure based on artificial intelligent analysis of CT imaging data

Establishment of a dynamic assessment system for reducing the risk of cardioembolic stroke following left atrial appendage closure based on artificial intelligent analysis of CT imaging data

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092582
Enrollment
Unknown
Registered
2024-11-19
Start date
2024-04-10
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardioembolic stroke

Interventions

Exposed Group:None
Control Group:None

Sponsors

The Sixth Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) Age >= 18 years; 2) The diagnosis of atrial fibrillation was based on the patient's admission electrocardiogram, 24-hour ambulatory electrocardiogram, and reference to the ESC2020 atrial fibrillation guideline diagnostic criteria; 3) CHA2DS2-VASc score:male >= 2 score, female >= 3 score(C:Congestive heart failure,H: Hypertension, A: Age >= 75 years, D: Diabetes mellitus, S: Stroke, V: Vascular disease, A: Age 65-74 years, Sc: Sex category (female)); 4) Contraindications to oral anticoagulant therapy or HAS-BLED score >=3 score(Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs/alcohol concomitantly; 1 point each ); 5) Patients after percutaneous left atrial appendage closure; 6) Patients volunteered for CT imaging follow-up.

Exclusion criteria

Exclusion criteria: 1) Device implantation >= 2; 2) Subjects had a life expectancy of less than 2 years; 3) Patients with complications during LAAC; 4) Patients who are participating in other interventional clinical trials; 5) Those who refused to participate or were clearly unable to complete the follow-up visit at the established time point.

Design outcomes

Primary

MeasureTime frame
The composite endpoint of stroke, systemic embolism, transient ischemic attack, cardiovascular death, death of unknown cause, and all-cause mortality within 24 months after discharge.;

Secondary

MeasureTime frame
Peri-device leak;Device-related thrombus;Bleeding Events;Device Shoulder Protrusion;

Countries

China

Contacts

Public ContactChen Tao

The Sixth Medical Center of PLA General Hospital

chentao301@126.com+86 137 1775 8562

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026