Safety and Effectiveness of Short-Term Single AntiPlatelet Therapy After Left Atrial Appendage Closure With the LAmbre Device in Patients With Nonvalvular Atrial Fibrillation: A Multinational Real-world Registry

NCT06620757 | Recruiting DMC

• 1 other identifier: EPIC39-S-SAPT LAMBRE
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 22

Brief Summary

Brief Summary: A prospective, multicenter, single-arm, non-randomized study including consecutive patients with nonvalvular AF(Atrial Fibrillation), with a CHA2DS2-VASc score ≥2 (men) or ≥3 (women), and contraindication for long-term anticoagulant treatment, with successful LAAC (Left Atrial Appendage Closure)procedure with the LAmbre device, who at discharge are eligible for short-term (3-months-only) SAPT. We want to assess if a short-term single antiplatelet therapeutic regime of Acetylsalicylic acid (ASA) 100 mg (or clopidogrel 75 mg if ASA contraindication), once daily, for 3 months is safe and effective at 12 months follow-up.

Conditions

Atrial Fibrillation

Keywords

Left Atrial Appendage Closure; Single Antiplatelet Therapy

Outcome Measures

Primary Outcomes (1)

• Composite of stroke

  A composite of stroke (including ischemic and/or hemorrhagic) and/or systemic embolism

  12 month

Secondary Outcomes (6)

• Device thrombosis

  45 days to 90 days

• Device thrombosis

  12 months

• Cardiovascular death

  12 months

• Major bleeding

  12 months

• Composite of cardiovascular death

  12 months

Study Arms (1)

Single Antiplatelet therapy after Left Atrial Appendage Occlusion (LAAO)

Drug: Single antiplatelet therapy (SAPT)

Interventions

Single antiplatelet therapy (SAPT) DRUG

Observational study of effectiveness and safety of SAPT (either with acetyl-salycilic acid or clopidogrel) after LAAO with Lambre device in patients with high risk of bleeding

Single Antiplatelet therapy after Left Atrial Appendage Occlusion (LAAO)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with nonvalvular AF, with a CHA₂DS₂-VASc score ≥2 (men) or ≥3 (women), contraindication for long-term anticoagulant treatment, with implantation procedural success of LAAC with the LAmbre device, who at discharge are eligible for short-term (3-months-only) SAPT

You may qualify if:

• All criteria must be met
• Patient 18 years and over and
• Patient with documented nonvalvular AF, defined as AF in the absence of moderate or severe mitral stenosis or a mechanical heart valve and
• Patient with a calculated CHA₂DS₂-VASc score ≥2 (for men) and ≥3 (for women) and
• Patient with a contraindication for long-term anticoagulant treatment and
• Patient who has undergone a successful LAmbre LAAC device implantation with no complications during the in-hospital period after the intervention and
• Patient able and willing to return for required follow-up visits and examinations and
• Patient with Informed consent signed.

You may not qualify if:

• Patient is currently enrolled in another investigational study, except when the subject is participating in a purely observational registry with no associated treatments.
• Patient requires long-term anticoagulation therapy for reasons other than AFrelated stroke risk reduction, for example, due to an underlying hypercoagulable state (i.e even if the device is implanted, the subjects would not be eligible to discontinue OAC (Oral Anticoagulation) due to other medical conditions requiring chronic OAC therapy).
• Patient has contraindications or is allergic to both aspirin and clopidogrel.
• Patient has an indication for chronic aspirin or clopidogrel treatment (i.e., chronic ischemic disease or peripheral artery disease); thus, the subject would not be eligible to discontinue aspirin or clopidogrel due to other medical conditions requiring this therapy.
• Patient had or is planning to have any cardiac or noncardiac intervention or surgical procedure within 30 days before or 60 days after implant (including, but not limited to: cardioversion, PCI (Percutaneous Coronary Intervention), cardiac ablation, cataract surgery, etc.).
• Patient had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 30 days prior to enrollment.
• Patient has an active bleeding.
• Patient has had an MI documented in the clinical record as either a NSTEMI or STEMI, with or without intervention, within 30 days prior to enrollment.
• Patient has a history of atrial septal repair or has an ASD/PFO device.
• Patient is of childbearing potential, or plans to become pregnant during the study (method of assessment upon study physician's discretion).
• Patient had subject has a documented life expectancy of less than one year.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (22)

Hospital Universitario A Coruña

A Coruña, 15006, Spain

RECRUITING

Hospital Clínico San Carlos

Aravaca, 28040, Spain

RECRUITING

Hospital Del Mar

Barcelona, 08003, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital Universitario Reina Sofía de Córdoba

Córdoba, 14004, Spain

RECRUITING

Hospital Universitario La Paz

Fuencarral-El Pardo, 28046, Spain

RECRUITING

Hospital Universitario de Cabueñes

Gijón, 33394, Spain

RECRUITING

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

RECRUITING

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, 35010, Spain

RECRUITING

Hospital Universitario de Leon

León, 24008, Spain

RECRUITING

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

RECRUITING

Hospital Central de La Defensa Gómez Ulla

Madrid, 28047, Spain

RECRUITING

Hospital Universitario Puerta De Hierro

Majadahonda, 28222, Spain

RECRUITING

Hospital de Manises

Manises, 46940, Spain

RECRUITING

Hospital Regional Universitario de Málaga

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Son Espases

Palma de Mallorca, 07120, Spain

RECRUITING

Hospital Clínico Universitario de Salamanca

Salamanca, 37007, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Hospital Universitario de Tarragona Juan XXIII

Tarragona, 43005, Spain

RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, 46026, Spain

RECRUITING

Related Publications (10)

• Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

  PMID: 32860505 BACKGROUND

• Krijthe BP, Kunst A, Benjamin EJ, Lip GY, Franco OH, Hofman A, Witteman JC, Stricker BH, Heeringa J. Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060. Eur Heart J. 2013 Sep;34(35):2746-51. doi: 10.1093/eurheartj/eht280. Epub 2013 Jul 30.

  PMID: 23900699 BACKGROUND

• Michaud GF, Stevenson WG. Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):353-361. doi: 10.1056/NEJMcp2023658. No abstract available.

  PMID: 33503344 BACKGROUND

• Alkhouli M, Ellis CR, Daniels M, Coylewright M, Nielsen-Kudsk JE, Holmes DR. Left Atrial Appendage Occlusion: Current Advances and Remaining Challenges. JACC Adv. 2022 Nov 16;1(5):100136. doi: 10.1016/j.jacadv.2022.100136. eCollection 2022 Dec.

  PMID: 38939465 BACKGROUND

• Glikson M, Wolff R, Hindricks G, et al. EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion - an update. Europace 2022; 24(1): 71-164.

  BACKGROUND

• Freeman JV, Higgins AY, Wang Y, Du C, Friedman DJ, Daimee UA, Minges KE, Pereira L, Goldsweig AM, Price MJ, Reddy VY, Gibson D, Doshi SK, Varosy PD, Masoudi FA, Curtis JP. Antithrombotic Therapy After Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2022 May 10;79(18):1785-1798. doi: 10.1016/j.jacc.2022.02.047.

  PMID: 35512858 BACKGROUND

• Carvalho PEP, Gewehr DM, Miyawaki IA, Nogueira A, Felix N, Garot P, Darmon A, Mazzone P, Preda A, Nascimento BR, Kubrusly LF, Cardoso R. Network Meta-Analysis of Initial Antithrombotic Regimens After Left Atrial Appendage Occlusion. J Am Coll Cardiol. 2023 Oct 31;82(18):1765-1773. doi: 10.1016/j.jacc.2023.08.010. Epub 2023 Aug 21.

  PMID: 37611779 BACKGROUND

• Korsholm K, Nielsen KM, Jensen JM, Jensen HK, Andersen G, Nielsen-Kudsk JE. Transcatheter left atrial appendage occlusion in patients with atrial fibrillation and a high bleeding risk using aspirin alone for post-implant antithrombotic therapy. EuroIntervention. 2017 Apr 20;12(17):2075-2082. doi: 10.4244/EIJ-D-16-00726.

  PMID: 27973336 BACKGROUND

• Park JW, Sievert H, Kleinecke C, Vaskelyte L, Schnupp S, Sievert K, Lam YY, Stahli BE, Zhang D, Li A, Brachmann J. Left atrial appendage occlusion with lambre in atrial fibrillation: Initial European experience. Int J Cardiol. 2018 Aug 15;265:97-102. doi: 10.1016/j.ijcard.2018.02.120.

  PMID: 29885707 BACKGROUND

• Llagostera-Martin M, Cainzos M, Salvatella N, Cubero-Gallego H, Mas-Stachurska A, Sanchez-Carpintero A, Tizon-Marcos H, Calvo-Fernandez A, Molina L, Vaquerizo B. Single antiplatelet therapy after left atrial appendage closure in patients with AF: safety and effectiveness. Rev Esp Cardiol (Engl Ed). 2024 Feb;77(2):150-157. doi: 10.1016/j.rec.2023.06.020. Epub 2023 Oct 23. English, Spanish.

  PMID: 37879431 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

BEATRIZ VAQUERIZO, MD, PhD

CONTACT

0034987876135; bvaquerizo@psmar.cat

FUNDACION EPIC

CONTACT

34987876135; iepic@fundacionepic.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (22)