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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.
The S-SAPT SECURE-LAMBRE REGISTRY is a prospective, multicenter, single-arm, non-randomized study including consecutive patients with nonvalvular AF, with a CHA2DS2-VASc score ≥2 (men) or ≥3 (women), and contraindication for long-term anticoagulant treatment, with successful LAAC procedure with the LAmbre device, who at discharge are eligible for short-term (3-months-only) SAPT.
234 patients will be enrolled in the study. The study will be conducted at about 20 investigational centers in Spain. The enrollment phase is expected to take approximately 18 months.
Patients included in the study will be clinically followed for 12 months. In addition patients will have imaging (TEE or cCT) follow-up at 45-90 days and 12 month.
The hypothesis of the study is the following: After successful procedure of implantation of the Lifetech LAmbre Left Atrial Appendage Closure (LAAC) device in patients with nonvalvular paroxysmal, persistent, or permanent Atrial Fibrillation (AF), 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.
Objectives:
Primary objective. To evaluate the occurrence of stroke and thromboembolic events at 12 months with short-term SAPT with ASA 100 mg (or clopidogrel 75 mg if ASA contraindication) once daily during 3 months after successful LAAC with the LAmbre device.
Secondary objective. To evaluate the occurrence of major bleeding events at 12 months with short-term SAPT with ASA 100 mg (or clopidogrel 75 mg if ASA contraindication) during 3 months after successful LAAC with the LAmbre device.
Endpoints:
Primary endpoint. A composite of stroke (including ischemic and/or hemorrhagic) and/or systemic embolism at 12 months.
Secondary endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Antiplatelet therapy after Left Atrial Appendage Occlusion (LAAO) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of stroke | A composite of stroke (including ischemic and/or hemorrhagic) and/or systemic embolism | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Device thrombosis | Freedom from device thrombosis by Echocardiography (TEE), confirmed by a cardiac Computed Tomography (CT) scan | 45 days to 90 days |
| Device thrombosis | Freedom from device thrombosis by Transesophageal Echocardiography (TEE), confirmed by a cardiac Computed Tomography (CT) scan |
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Inclusion Criteria:
All criteria must be met
Exclusion Criteria:
No exclusion criteria must be met.
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BEATRIZ VAQUERIZO, MD, PhD | Contact | 0034987876135 | bvaquerizo@psmar.cat | |
| FUNDACION EPIC | Contact | 34987876135 | iepic@fundacionepic.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario A Coruña | Recruiting | A Coruña | 15006 | Spain | ||
| Hospital Clínico San Carlos |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32860505 | Background | 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. | |
| 23900699 |
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| 12 months |
| Cardiovascular death | Freedom of Cardiovascular death | 12 months |
| Major bleeding | Freedom from major bleeding events according to Academy Consortium [BARC] ≥3b) | 12 months |
| Composite of cardiovascular death | Freedom from stroke, systemic embolism, and nonprocedural bleeding | 12 months |
| All cause of death | Freedom from All cause of death | 12 month |
| Recruiting |
| Aravaca |
| 28040 |
| Spain |
| Hospital Del Mar | Recruiting | Barcelona | 08003 | Spain |
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08025 | Spain |
| Hospital Universitari Vall D'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hospital Universitario Reina Sofía de Córdoba | Recruiting | Córdoba | 14004 | Spain |
| Hospital Universitario La Paz | Recruiting | Fuencarral-El Pardo | 28046 | Spain |
| Hospital Universitario de Cabueñes | Recruiting | Gijón | 33394 | Spain |
| Hospital Universitario de Bellvitge | Recruiting | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital Universitario de Gran Canaria Doctor Negrín | Recruiting | Las Palmas de Gran Canaria | 35010 | Spain |
| Hospital Universitario de Leon | Recruiting | León | 24008 | Spain |
| Hospital Universitari Arnau de Vilanova | Recruiting | Lleida | 25198 | Spain |
| Hospital Central de La Defensa Gómez Ulla | Recruiting | Madrid | 28047 | Spain |
| Hospital Universitario Puerta De Hierro | Recruiting | Majadahonda | 28222 | Spain |
| Hospital de Manises | Recruiting | Manises | 46940 | Spain |
| Hospital Regional Universitario de Málaga | Recruiting | Málaga | 29010 | Spain |
| Hospital Universitario Son Espases | Recruiting | Palma de Mallorca | 07120 | Spain |
| Hospital Clínico Universitario de Salamanca | Recruiting | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen del Rocío | Recruiting | Seville | 41013 | Spain |
| Hospital Universitario de Tarragona Juan XXIII | Recruiting | Tarragona | 43005 | Spain |
| Hospital Universitario y Politécnico La Fe | Recruiting | Valencia | 46026 | Spain |
| 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. |
| 33503344 | 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. |
| 38939465 | 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. |
| 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. |
| 35512858 | 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. |
| 37611779 | 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. |
| 27973336 | 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. |
| 29885707 | 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. |
| 37879431 | 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. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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