Status:
UNKNOWN
Clinical Outcomes Between Anticoagulation and DAPT Therapy in AF Patients Successfully Undergoing LAAO
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Left Atrial Appendage Thrombosis
Thrombi
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The objective of this study is to assess the efficacy and safety different dosage of rivaroxaban application versus dual antiplatelet therapy after successful closure of left atrial appendage using th...
Detailed Description
Transcatheter left atrial appendage occlusion(LAAO) has emerged as an effective alternative for preventing thromboembolic events in patients with nonvalvular atrial fibrillation. The contemporary stra...
Eligibility Criteria
Inclusion
- Successful transcatheter LAAC using LAMBRE with COST criteria met by intra-procedural TEE and LAA angiography;
- Cha2ds2-Vasc2 score≥2 and or Has-bled score≥3(with contraindication or self-refusal to long-term administration of oral anticoagulants);
- Age18-85 years old;
- Life expectancy≥1 year;
- Written informed consent obtained;
Exclusion
- • Prior history of cardiac surgery or with need for intervention in limited intervals;
- Intolerant of TEE or with clinical contraindications for TEE
- Detection of LAA/LA thrombus prior to the procedure;
- Anteroposterior diameter of LAA≥60mm according to TTE
- Impairment of renal function: eGFR≤15ml/min and/or creatinine level≥200μmol/L;
- Patients with hepatic disease that is associated with abnormal blood coagulation(cirrhosis: Child Pugh B an C);
- PLT ≤ 50\*10\^9/L;
- LVEF≤35% and/or NYHA≥IV；
- Allergies or contraindications to antiplatelet or anticoagulation therapy;
- At high risk of major bleedin(such as gastrointestinal ulcer at present or recently, malignant tumor with high risk of hemorrhage, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, angioaneurysms or major intraspinal or intracerebral vascular malformations, et al)
- Patients with requirement for anticoagulation therapy due to other diseases besides atrial fibrillation (such as after mechanical valve replacement, spontaneous or recurrent venous thromboembolism, etc.);
- Occurrence of severe pericardial tamponade, major hemorrhage and other life-threatening complications after left atrial appendage closure;
- Combined with other basic complications necessary to take drugs that may affect the effect of anticoagulation and antithrombotic regimen in this study(such as pyrrole antifungal agent, human acquired immunodeficiency virus (HIV) protease inhibitor, anti arrhythmia drug dronedarone, powerful cytochrome enzyme CYP3A4 inducer including rifampicin, phenytoin sodium, carbamazepine, phenobarbital, and other anticoagulants).
- Enrolled in other clinical studies in progress;
- Researches think that the patient is not suitable to participate in this study.
Key Trial Info
Start Date :
November 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2024
Estimated Enrollment :
826 Patients enrolled
Trial Details
Trial ID
NCT04135677
Start Date
November 11 2022
End Date
October 30 2024
Last Update
November 15 2022
Active Locations (1)
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1
Zhongshan Hospital, Fudan Univerisity
Shanghai, Shanghai Municipality, China, 200032