Clinical Outcomes Between Anticoagulation and DAPT Therapy in AF Patients Successfully Undergoing… (NCT04135677) | Clinical Trial Compass
UnknownPhase 4
Clinical Outcomes Between Anticoagulation and DAPT Therapy in AF Patients Successfully Undergoing LAAO
China826 participantsStarted 2022-11-11
Plain-language 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 the LAMBRE device.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* • 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 replace…