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

Low-dose Rivaroxaban Monotherapy Versus Guideline Determined Medication Therapy After Left Atrial Appendage Occlusion: a Randomized, Open-label, Multicentre, Superiority Trial

This study is testing if low-dose blood thinners are just as good or better than standard treatment for people with atrial fibrillation after they have had a procedure to close off a part of their heart.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 4220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xijing Hospital (Academic / other)
• Locations: 1 site (Xi'an, Shannxi)
• Trial ID: NCT05960721 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with non-valvular atrial fibrillation who have successfully undergone left atrial appendage occlusion.

Not a fit: Patients under 18, those unable to provide informed consent, or with life-threatening comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and safer anticoagulation strategies for patients with atrial fibrillation after LAAO.

How similar studies have performed: Previous studies have shown that LAAO is effective in stroke prevention, but this specific comparison of low-dose NOACs versus GDMT is novel.

Eligibility criteria

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 this trial is running

Xi'an, Shannxi

• Ling Tao — Xi'an, Shannxi, China (Recruiting)

Study contacts

• Study coordinator: Chao Gao, M.D., Ph.D.

Conditions Atrial Fibrillation; Left atrial appendage occlusion; Anti-coagulation