Afib Atrial fibrillation
Conditions
Interventions
Percutaneous LAAO will be performed and afterwards patient will receive aspirin
and clopidogrel for at least 45 days followed by aspirin up to 12 months. The
control group may use APT agent(s) or no
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Documented non-valvular AF (paroxysmal or non-paroxysmal) and 2. CHA2DS2-VASc score of 2 or more and 3. unsuitable for long-term use of oral anticoagulation as determined by the referring physician team as well as the multidisciplinary team in the study hospital and 4. suitable for dual ATP for at least 3 mo and single APT from 3 until at most 12 mo and 5. At least 18 years of age, and willing and able to provide informed consent and adhere to study rules and regulations and follow-up
Exclusion criteria
Exclusion criteria: 1. any invasive cardiac procedure within 30 days prior to randomization and 90 days after LAAO that would interfere with the study follow-up and medication 2. unsuitable LAA anatomy for closure or thrombus in the LAA at the time of procedure 3. contraindications or unfavourable conditions to perform cardiac catheterization or TEE 4. atrial septal malformations, atrial septal defect or a high-risk patient foramen ovale that may cause thrombo-embolic events 5. atrial septal defect repair or closure device or a patent foramen ovale repair or any other anatomical condition as this may preclude an LAAO procedure 6. LVEF50 mmHg) or regurgitation grade 3 or more 10. Planned cardiac surgery for any reason within 3 months 11. Stroke within the 3 months prior to inclusion 12. Major bleeding (BARC criteria>type 2) within 1 month prior to inclusion or longer if it has not been resolved yet 13. Compelling medical reason to use VKA or NOAC (e.g. mechanical heart valve, pulmonary embolism, ventricular aneurysm) 14. Major contraindications for using aspirin or clopidogrel 15. (planned) pregnancy 16. Participation in any other clinical trial that interferes with the current study 17. Life expectancy of less than 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 2 co-primary outcomes are time to first occurrence of stroke and/or stroke/TIA/systemic embolism. With a conservative relative risk reduction of 0.5, an endpoint driven trial aiming at 72 primary outcomes for stroke may achieve 85% power to show superiority of LAAO over not using oral anticoagulation within 5 years (Cox proportional hazards model, 2-sided testing, significance level of 5%). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will include peri-procedural 30-day safety, QoL score at 1-yr, and cost-effectiveness analyses. Cost-effectiveness and cost-utility analyses of LAAO against standard care will be performed from a societal perspective with 5 years and lifetime horizon. Outcome measures are the costs/yr free of cardiovascular event and cardio-embolic stroke, and per quality adjusted life year. The prevalent health care budget impact of LAAO diffusion will be assessed during the first 4 years after the study | — |
Countries
Netherlands
Outcome results
None listed