Status:
UNKNOWN
Platelet-activation and Optimal Inhibition in Patients With Atrial Fibrillation Undergoing Left Atrial Appendage Occlusion
Lead Sponsor:
R&D Cardiologie
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
The POPULAR-LAAO registry is an open-label observational prospective registry to investigate hemostatic processes following left atrial appendage occlusion.
Detailed Description
This is an open-label observational prospective registry. The aim is to develop a better understanding of coagulation, platelet reactivity and prothrombotic factors in the first months after left atri...
Eligibility Criteria
Inclusion
- The subject is aged 18 years or older
- The subject is accepted/scheduled for left atrial appendage occlusion
- The subject has a CHA₂DS₂-VASc Score ≥2 (male) or ≥3 (female)
- The subject or legal representative is able to understand and is willing to provide written informed consent to participate in the trial.
Exclusion
- Unable or unwilling to return for required follow-up visits and examinations
- Mechanical heart valves or valvular disease requiring surgery or interventional procedure
- Ongoing major bleeding or complicated or recent (\<72hours) major surgery
- Known large oesophageal varices or decompensated liver disease (unless a documented positive opinion of a gastro-enterologist)
- Severe thrombocytopenia (\<50,000/ml)
- High likelihood of being unavailable for follow-up or psycho-social condition making study participation impractical.
- Woman with child bearing potential who do not use an efficient method of contraception.
- Positive serum or urine pregnancy test for woman with child bearing potential
- Pregnancy or within 48 hours post-partum
- unsuitable LAA anatomy for occlusion or thrombus in the LAA at the time of procedure
- contraindications or unfavourable conditions to perform cardiac catheterization or transesophageal echocardiography (TEE)
- atrial septal malformations, atrial septal defect or a high-risk patent foramen ovale that may cause thrombo-embolic events
- 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
- Mitral valve regurgitation grade 3 or more
- Aortic valve stenosis (AVA\<1.0 cm2 or Pmax\>50 mmHg) or regurgitation grade 3 or more
- Planned carotid endarterectomy (CEA) for significant carotid artery disease
- Life expectancy of less than 1 year
Key Trial Info
Start Date :
February 24 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04705688
Start Date
February 24 2021
End Date
December 1 2024
Last Update
March 12 2021
Active Locations (1)
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1
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands, 3430 EM