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

NCT04705688 | Unknown

• 1 other identifier: RDC-2020.02
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atrial Fibrillation

Keywords

Left atrial appendage occlusion; Device-related thrombus; Platelet reactivity; Coagulation activation

Outcome Measures

Primary Outcomes (3)

• Change in coagulation activation

  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

  Influence of LAAO on platelet reactivity over time

  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

  Pre-LAAO

Secondary Outcomes (3)

• Separate and composite event rates of stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), systemic embolism and cardiovascular death.

  Post-LAAO (3 months, 6 months, 12 months)

• Major and minor bleeding event rate (according to Bleeding Academic Research Consortium criteria)

  Post-LAAO (3 months, 6 months, 12 months)

• Device related thrombus event rate

  Post-LAAO (3 months, 12 months)

Study Arms (1)

Left Atrial Appendage Occlusion

Patients undergoing left atrial appendage occlusion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• R&D Cardiologie: lead

Study Sites (1)

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 3430 EM, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be preserved for analysis of hemostatic markers and CYP2C19 genotyping.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lucas VA Boersma, MD PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas VA Boersma, MD PhD

CONTACT

+31 088 320 3000; l.boersma@antoniusziekenhuis.nl

Errol W Aarnink, MD

CONTACT

+31 088 320 3000; e.aarnink@antoniusziekenhuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 12, 2021
• Study Start: February 24, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

NL (1)