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Platelet-activation and Optimal Inhibition in Patients With Atrial Fibrillation Undergoing Left Atrial Appendage Occlusion (POPULAR-LAAO)

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ClinicalTrials.gov Identifier: NCT04705688
Recruitment Status : Recruiting
First Posted : January 12, 2021
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
L.V.A. Boersma, R&D Cardiologie

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

Condition or disease
Atrial Fibrillation

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 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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Platelet-activation and Optimal Inhibition in Patients With Atrial Fibrillation Undergoing Left Atrial Appendage Occlusion; The POPULAR-LAAO Trial
Actual Study Start Date : February 24, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Left Atrial Appendage Occlusion
Patients undergoing left atrial appendage occlusion.


Outcome Measures
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Primary Outcome Measures :
  1. Change in coagulation activation [ Time Frame: Pre-LAAO and post-LAAO (1 day, 2 weeks, 3 months, 6 months) ]
    Influence of LAAO on coagulation activation over time

  2. Change in platelet reactivity [ Time Frame: Pre-LAAO and post-LAAO (1 day, 2 weeks, 3 months, 6 months) ]
    Influence of LAAO on platelet reactivity over time

  3. CYP2C19 genotype [ Time Frame: Pre-LAAO ]
    Rate of clopidogrel non-responders among LAAO patients will be assessed by determining CYP2C19 genotype


Secondary Outcome Measures :
  1. Separate and composite event rates of stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), systemic embolism and cardiovascular death. [ Time Frame: Post-LAAO (3 months, 6 months, 12 months) ]
  2. Major and minor bleeding event rate (according to Bleeding Academic Research Consortium criteria) [ Time Frame: Post-LAAO (3 months, 6 months, 12 months) ]
  3. Device related thrombus event rate [ Time Frame: Post-LAAO (3 months, 12 months) ]

Biospecimen Retention:   Samples With DNA
Blood samples will be preserved for analysis of hemostatic markers and CYP2C19 genotyping.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist of patients with non-valvular AF at high risk for cardio-embolic stroke scheduled for left atrial appendage occlusion.
Criteria

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 provide written informed consent to participate in the trial.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705688


Contacts
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Contact: Lucas VA Boersma, MD PhD +31 088 320 3000 l.boersma@antoniusziekenhuis.nl
Contact: Errol W Aarnink, MD +31 088 320 3000 e.aarnink@antoniusziekenhuis.nl

Locations
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Netherlands
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Utrecht, Netherlands, 3430 EM
Contact: L.V.A. Boersma, MD PhD         
Principal Investigator: L.V.A. Boersma, MD PhD         
Sub-Investigator: E.W. Aarnink, MD         
Sponsors and Collaborators
R&D Cardiologie
Investigators
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Principal Investigator: Lucas VA Boersma, MD PhD ST. Antonius hospital Nieuwegein
More Information
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Responsible Party: L.V.A. Boersma, Clinical professor, R&D Cardiologie
ClinicalTrials.gov Identifier: NCT04705688    
Other Study ID Numbers: RDC-2020.02
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by L.V.A. Boersma, R&D Cardiologie:
Left atrial appendage occlusion
Device-related thrombus
Platelet reactivity
Coagulation activation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes