Comparing effectiveness and safety of Left Atrial Appendage Occlusion for non-valvular Atrial Fibrillation patients at high stroke risk unable to use oral anticoagulation therapy
- Conditions
- AfibAtrial fibrillation10007521
- Registration Number
- NL-OMON52211
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 609
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
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. LVEF<31% and/or heart failure NYHA 3-4
7. Mitral valve regurgitation grade 3 or more
8. Mitral stenosis as this makes AF by definition valvular in nature
9. Aortic valve stenosis (AVA<1.0 cm2 or Pmax>50 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The 2 co-primary outcomes are time to first occurrence of stroke and/or<br /><br>stroke/TIA/systemic embolism. With a conservative relative risk reduction of<br /><br>0.5, an endpoint driven trial aiming at 72 primary outcomes for stroke may<br /><br>achieve 85% power to show superiority of LAAO over not using oral<br /><br>anticoagulation within 5 years (Cox proportional hazards model, 2-sided<br /><br>testing, significance level of 5%). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes will include peri-procedural 30-day safety, QoL score at<br /><br>1-yr, and cost-effectiveness analyses. Cost-effectiveness and cost-utility<br /><br>analyses of LAAO against standard care will be performed from a societal<br /><br>perspective with 5 years and lifetime horizon. Outcome measures are the<br /><br>costs/yr free of cardiovascular event and cardio-embolic stroke, and per<br /><br>quality adjusted life year. The prevalent health care budget impact of LAAO<br /><br>diffusion will be assessed during the first 4 years after the study</p><br>