Platelet-activation and Optimal Inhibition in Patients With Atrial Fibrillation Undergoing Left Atrial Appendage Occlusion

Last updated: March 9, 2021
Sponsor: R&D Cardiologie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Atrial Fibrillation

Dysrhythmia

Treatment

N/A

Clinical Study ID

NCT04705688
RDC-2020.02
  • Ages > 18
  • All Genders

Study Summary

The POPULAR-LAAO registry is an open-label observational prospective registry to investigate hemostatic processes following left atrial appendage occlusion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 providewritten informed consent to participate in the trial.

Exclusion

Exclusion Criteria:

  • Unable or unwilling to return for required follow-up visits and examinations
  • Mechanical heart valves or valvular disease requiring surgery or interventionalprocedure
  • Ongoing major bleeding or complicated or recent (<72hours) major surgery
  • Known large oesophageal varices or decompensated liver disease (unless a documentedpositive opinion of a gastro-enterologist)
  • Severe thrombocytopenia (<50,000/ml)
  • High likelihood of being unavailable for follow-up or psycho-social condition makingstudy participation impractical.
  • Woman with child bearing potential who do not use an efficient method ofcontraception.
  • 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 ortransesophageal echocardiography (TEE)
  • atrial septal malformations, atrial septal defect or a high-risk patent foramen ovalethat may cause thrombo-embolic events
  • atrial septal defect repair or closure device or a patent foramen ovale repair or anyother 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

Study Design

Total Participants: 120
Study Start date:
February 24, 2021
Estimated Completion Date:
December 31, 2024

Study 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 atrial appendage occlusion, as occurrence of device-related thrombus and optimal postprocedural management remain a challenge after LAAO.

The study population will consist of patients with non-valvular atrial fibrillation (AF) at risk for cardio-embolic stroke scheduled for left atrial appendage occlusion. In these patients, blood samples for coagulation and platelet reactivity testing will be taken, which will be gathered prior to the procedure and 1 day, 14 days, 3 months and 6 months after the procedure. Data will be analyzed longitudinally and between groups based on patient characteristics.

Connect with a study center

  • St. Antonius Ziekenhuis

    Nieuwegein, Utrecht 3430 EM
    Netherlands

    Active - Recruiting

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