Status:
RECRUITING
LAAO Versus NOAC in Patients with AF and PCI
Lead Sponsor:
Xijing Hospital
Conditions:
Atrial Fibrillation
Percutaneous Coronary Intervention
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Atrial fibrillation (AF) coincides with coronary artery disease (CAD) shared common risk factors and pathophysiologic pathways. CAD affects approximately 25% of AF patient according to the trial Atria...
Eligibility Criteria
Inclusion
- Successful PCI for unstable angina or CCS
- Non-valvular atrial fibrillation
- Concomitant at least one of the following conditions: congestive heart failure, hypertension, ≥65yrs, diabetes, previous stroke, TIA or thromboembolism
- Eligible for long-term novel oral anti-coagulation (NOAC) therapy
- Able to understand and provide informed consent and comply with all study procedures/medications
Exclusion
- Patients who meet any of the following criteria will be disqualified from participation in the study:
- Clinical exclusion criteria:
- Under the age of 18
- Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint
- 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)
- Concurrent medical condition with a life expectancy of less than 3 years
- Haemodynamical unstable
- Known contraindication to medications such as heparin, antiplatelet or anticoagulation drugs, or contrast
- PCI for ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI), or experienced a peri-procedural myocardial infarction (MI) caused by PCI
- Known contraindication to LAAO or LAAO is not required
- Comorbidities other than atrial fibrillation that required long term use of anticoagulation (such as implanted a mechanical valve)
- The patient had or is planning to have any cardiac (excluding the current PCI procedure) or non-cardiac interventional or surgical procedure within 30 days prior to or 60 days after the WATCHMAN device implant (e.g., cardioversion, ablation, cataract surgery)
- Ongoing overt bleeding
- Previous stroke/TIA within 30 days of enrolment
- Symptomatic carotid artery disease
- Severe renal insufficiency (CrCl≤30ml/min)
- Imaging
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 20 2029
Estimated Enrollment :
1386 Patients enrolled
Trial Details
Trial ID
NCT05353140
Start Date
September 1 2022
End Date
September 20 2029
Last Update
March 7 2025
Active Locations (1)
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1
Ling Tao
Xi'an, Shannxi, China, 710032