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Low-dose NOAC Versus GDMT After LAAO

RecruitingNAAges 18 Years - anyAllXijing Hospital
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In plain words

What the trial is, and whether it could suit you

The increased risk of Atrial fibrillation (AF) regarding thromboembolic stroke is predominantly due to the formation and embolization of clots from within the left atrial appendage (LAA). Percutaneous left atrial appendage occlusion (LAAO) is a nonpharmacological strategy for stroke prevention in patients with AF. Data from randomized trials, including PROTECT-AF, PREVAIL, and Prague-17, have suggested that LAAO has comparable efficacy to warfarin or NOACs. Considering these results, LAAO was recommended by the American College of Cardiology (ACC) and European Society of Cardiology (ESC) guidelines as a non-pharmacological stroke prevention strategy for patients with NVAF who have contraindications or are unsuitable for OAC. The PROTECT-AF and PREVAIL trials stipulated the use of standardized antithrombotic medications which were designed to minimize the risk of stroke, systemic embolis

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Non-valvular atrial fibrillation (NVAF) patients with successful left atrial appendage occlusion (LAAO) 2. Eligible for guideline-directed anti-thrombotic therapy 3. Able to understand and provide informed consent and comply with all study medications Exclusion Criteria: 1. Under the age of 18 2. Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint 3. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice) 4. Concurrent medical condition with a life expectancy of less than two years 5. Haemodynamical unstable 6. Known contraindication to medications such as heparin, antiplatelet or anticoagulation drugs, or contrast 7. Peridevice leak \> 5mm as assessed immediately after LAAO or any other procedure-related complications 8. Comorbidities other than atrial fibrillation that required long term use of anticoagulation (such as implanted mechanical valve) 9. Percutaneous coronary intervention (PCI) within 1 year. 10. The patient had or is planning to have any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to or 60 days after the WATCHMAN device implant (e.g., PCI, cardioversion, cardiac surgery) 11. Ongoing overt bleeding 12. Previous stroke/TIA within 30 days of enrolment 13. Symptomatic carotid artery disease 14. Severe renal insufficiency (CrCl≤30ml/min/1.73m2)
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What it tests

  • Rivaroxaban 15mg
  • Aspirin 100mg
  • Clopidogrel 75mg
  • Rivaroxaban 10mg
  • Rivaroxaban 2.5mg
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Where

1 site
Ling Tao
Xi'an, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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