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Randomized controlled study of different antithrombotic strategies after occlusion of left atrial appendage with LACbes occluder

Randomized controlled study of different antithrombotic strategies after occlusion of left atrial appendage with LACbes occluder

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046712
Enrollment
Unknown
Registered
2021-05-27
Start date
2023-02-01
Completion date
Unknown
Last updated
2023-02-13

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

Conditions

Atrial Fibrillation

Interventions

Group 1:dual antiplatelet (aspirin+ticagrelor)

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 84 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years and = 2; 4. HAS-BLED score >= 3 or who refuse long-term anticoagulation therapy; 5. Successful occlusion of left atrial appendage with LACbes occluder; 6. Able to understand and give informed consent, and be able to accept follow-up (telephone and clinical follow-up).

Exclusion criteria

Exclusion criteria: 1. Mechanical prosthesis, evidence of thrombosis, complex atherosclerosis, or symptomatic carotid artery disease; 2. Contraindications of transesophageal echocardiography; 3. Platelet count < 60 x 10^9/L; 4. Left ventricular ejection fraction (LVEF) < 35%; 5. Severe renal failure, creatinine clearance rate < 30 ml/min/1.73m2 or severe liver disease defined as Child-Pugh score B or C; 6. Contraindications for any form of anticoagulation or antiplatelet therapy or allergy to the drug; 6. Patients who have a history of drug or alcohol abuse, or who are unable to quit drinking due to psychosocial reasons. 7. Patients with acute coronary syndrome treating with standard DAPT; 8. Injury or disease at significant risk of major bleeding; 9. A history of drug or alcohol abuse; 10. Pregnant or lactating women, or those who plan to become pregnant within one year; 11. Patients who have undergone catheter ablation for atrial fibrillation in the last three months; 12. The investigator judged that the patient had poor compliance and could not complete the study as required or the investigator judged that the patient was not suitable to participate in this study for other reasons.

Design outcomes

Primary

MeasureTime frame
clinical thromboembolic events;device-related thrombosis;major bleeding;all-cause mortality;

Secondary

MeasureTime frame
nuisance bleeding;endothelialization;

Countries

China

Contacts

Public ContactZhang Junfeng

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

jfzhang_dr@163.com+86 18917797639

Outcome results

None listed

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