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

March 9, 2021 updated by: L.V.A. Boersma, R&D Cardiologie

Platelet-activation and Optimal Inhibition in Patients With Atrial Fibrillation Undergoing Left Atrial Appendage Occlusion; The POPULAR-LAAO Trial

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3430 EM
        • Recruiting
        • St. Antonius Ziekenhuis
        • Contact:
          • L.V.A. Boersma, MD PhD
        • Principal Investigator:
          • L.V.A. Boersma, MD PhD
        • Sub-Investigator:
          • E.W. Aarnink, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-LAAO and post-LAAO (1 day, 2 weeks, 3 months, 6 months)
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
Pre-LAAO and post-LAAO (1 day, 2 weeks, 3 months, 6 months)
CYP2C19 genotype
Time Frame: Pre-LAAO
Rate of clopidogrel non-responders among LAAO patients will be assessed by determining CYP2C19 genotype
Pre-LAAO

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Post-LAAO (3 months, 6 months, 12 months)
Major and minor bleeding event rate (according to Bleeding Academic Research Consortium criteria)
Time Frame: Post-LAAO (3 months, 6 months, 12 months)
Post-LAAO (3 months, 6 months, 12 months)
Device related thrombus event rate
Time Frame: Post-LAAO (3 months, 12 months)
Post-LAAO (3 months, 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Lucas VA Boersma, MD PhD, St. Antonius Hospital Nieuwegein

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2021

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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