Comparing low-dose anticoagulation to standard therapy after left atrial appendage closure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of low-dose novel oral anticoagulants (NOACs) compared to guideline-directed medical therapy (GDMT) in patients with non-valvular atrial fibrillation who have undergone successful left atrial appendage occlusion (LAAO). The trial aims to determine if low-dose anticoagulation can provide similar or improved outcomes in preventing thromboembolic events. Participants will be monitored for stroke, systemic embolism, and device-related complications while receiving either low-dose NOACs or standard therapy. The findings could help refine post-LAAO management strategies for patients with atrial fibrillation.

Why it matters

Who can join: the full rules

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)

Where it's running

• Ling Tao
  Xi'an, Shannxi, China Recruiting

Study contacts

• Study coordinator: Chao Gao, M.D., Ph.D.
• Email: woshigaochao@gmail.com
• Phone: +86-18629551066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.