Skip to content

A Prospective Multicenter Randomized Clinical Trial to Evaluate the Clinical Safety and Efficacy of Percutaneous Left Atrial Appendage Occlusion Using a 3D Left Atrial Appendage Model Simulation

Clinical usefulness of digital twin and 3D model simulation for percutaneous left atrial appendage occlusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010282
Enrollment
92
Registered
2025-03-11
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

None listed

Interventions

Procedure/Surgery : Eligible participants who have consented to participate in the study and meet the inclusion/exclusion criteria will be enrolled. Enrolled participants will be randomly assigned in

Sponsors

Korea University Ansan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adults aged 19 years or older who require anticoagulation therapy for stroke prevention due to atrial fibrillation but have contraindications or are unsuitable for long-term anticoagulant use, such as a history of severe bleeding events or high-risk comorbidities. Patients with atrial fibrillation who experience stroke or systemic thromboembolic events despite appropriate anticoagulation therapy, making medication alone insufficient for effective prevention.

Exclusion criteria

Exclusion criteria: Patients who do not consent to participate in the study. Patients deemed unsuitable for the procedure, where the investigator determines that the potential risks outweigh the expected benefits of the treatment.

Design outcomes

Primary

MeasureTime frame
Procedure-related complications ;Occurrence of acute ischemic brain lesions related to the procedure.

Secondary

MeasureTime frame
Evaluation of procedural outcomes ;Incidence of Thrombotic/Bleeding Events

Countries

Korea, Republic of

Contacts

Public ContactSeung Yong Shin

Korea University Ansan Hospital

theshin04@korea.ac.kr+82-31-8099-3260

Outcome results

None listed

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