- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04705688
Platelet-activation and Optimal Inhibition in Patients With Atrial Fibrillation Undergoing Left Atrial Appendage Occlusion (POPULAR-LAAO)
Platelet-activation and Optimal Inhibition in Patients With Atrial Fibrillation Undergoing Left Atrial Appendage Occlusion; The POPULAR-LAAO Trial
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Lucas VA Boersma, MD PhD
- Phone Number: +31 088 320 3000
- Email: l.boersma@antoniusziekenhuis.nl
Study Contact Backup
- Name: Errol W Aarnink, MD
- Phone Number: +31 088 320 3000
- Email: e.aarnink@antoniusziekenhuis.nl
Study Locations
-
-
Utrecht
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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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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)
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Influence of LAAO on coagulation activation over time
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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
Sponsor
Investigators
- Principal Investigator: Lucas VA Boersma, MD PhD, St. Antonius Hospital Nieuwegein
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RDC-2020.02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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