Atrial FibrillationPOPULAR-LAAONCT04705688
Platelet-activation and Optimal Inhibition in Patients With Atrial Fibrillation Undergoing Left Atrial Appendage Occlusion
An observational study of Atrial Fibrillation, run by R&D Cardiologie at 1 site in Netherlands.
Trial summary
The POPULAR-LAAO registry is an open-label observational prospective registry to investigate hemostatic processes following left atrial appendage occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Feb 2021to Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, 3430 EM
L.V.A. Boersma, MD PhD
L.V.A. Boersma, MD PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Keywords
- Left atrial appendage occlusion, Device-related thrombus, Platelet reactivity, Coagulation activation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Left Atrial Appendage Occlusion | Patients undergoing left atrial appendage occlusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in coagulation activation
Influence of LAAO on coagulation activation over time
Measured: Pre-LAAO and post-LAAO (1 day, 2 weeks, 3 months, 6 months)
Change in platelet reactivity
Influence of LAAO on platelet reactivity over time
Measured: Pre-LAAO and post-LAAO (1 day, 2 weeks, 3 months, 6 months)
CYP2C19 genotype
Rate of clopidogrel non-responders among LAAO patients will be assessed by determining CYP2C19 genotype
Measured: Pre-LAAO
Secondary outcomes (3)
Separate and composite event rates of stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), systemic embolism and cardiovascular death.
Measured: Post-LAAO (3 months, 6 months, 12 months)
Major and minor bleeding event rate (according to Bleeding Academic Research Consortium criteria)
Measured: Post-LAAO (3 months, 6 months, 12 months)
Device related thrombus event rate
Measured: Post-LAAO (3 months, 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start24 Feb 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- R&D Cardiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, L.V.A. Boersma, R&D Cardiologie
- Investigators
- Lucas VA Boersma, MD PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705688
- Sponsor's protocol ID
- RDC-2020.02
- Acronym
- POPULAR-LAAO
- Status last verified
- Mar 2021
- First submitted
- 22 Dec 2020
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-activation and Optimal Inhibition in Patients With Atrial Fibrillation Undergoing Left Atrial Appendage Occlusion; The POPULAR-LAAO Trial
- ClinicalTrials.gov ID
- NCT04705688
- Acronym / sponsor ID
- POPULAR-LAAO / RDC-2020.02
- Conditions
- Atrial Fibrillation
- Keywords
- Left atrial appendage occlusion, Device-related thrombus, Platelet reactivity, Coagulation activation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- R&D CardiologieUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Left Atrial Appendage Occlusion | – | –Patients undergoing left atrial appendage occlusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
CYP2C19 genotype
Time frame: Pre-LAAO
Rate of clopidogrel non-responders among LAAO patients will be assessed by determining CYP2C19 genotype
3 secondary outcomes
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)
Major and minor bleeding event rate (according to Bleeding Academic Research Consortium criteria)
Time frame: Post-LAAO (3 months, 6 months, 12 months)
Device related thrombus event rate
Time frame: Post-LAAO (3 months, 12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas VA Boersma, MD PhD principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by R&D Cardiologie at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucas VA Boersma, MD PhD (+31 088 320 3000, l.boersma@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in coagulation activation (time frame: Pre-LAAO and post-LAAO (1 day, 2 weeks, 3 months, 6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.