Atrial FibrillationS-SAPT LAMBRENCT06620757
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
An observational study of Atrial Fibrillation, run by Fundación EPIC at 22 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Single antiplatelet therapy (SAPT)
- How many people
- 234 participants
- Where
- 22 sitesSpain
- Study dates
- 10 Oct 2024to 20 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- No exclusion criteria must be met.
- 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.).
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- 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 had a major bleeding event within the 30 days prior to inclusion. Lack of resolution of related clinical sequelae or planned and pending interventions to resolve bleeding/bleeding source are further exclusions, regardless of the timing of the bleeding event.
- 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.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
Spain22 sites, 22 recruiting
- Recruiting
Hospital Universitario A Coruña
A Coruña, 15006
- Recruiting
Hospital Clínico San Carlos
Aravaca, 28040
- Recruiting
Hospital Del Mar
Barcelona, 08003
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
- Recruiting
Hospital Universitari Vall D'Hebron
Barcelona, 08035
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
Hospital Universitario Reina Sofía de Córdoba
Córdoba, 14004
- Recruiting
Hospital Universitario La Paz
Fuencarral-El Pardo, 28046
- Recruiting
Hospital Universitario de Cabueñes
Gijón, 33394
- Recruiting
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, 08907
- Recruiting
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, 35010
- Recruiting
Hospital Universitario de Leon
León, 24008
- Recruiting
Hospital Universitari Arnau de Vilanova
Lleida, 25198
- Recruiting
Hospital Central de La Defensa Gómez Ulla
Madrid, 28047
- Recruiting
Hospital Universitario Puerta De Hierro
Majadahonda, 28222
- Recruiting
Hospital Regional Universitario de Málaga
Málaga, 29010
- Recruiting
Hospital de Manises
Manises, 46940
- Recruiting
Hospital Universitario Son Espases
Palma de Mallorca, 07120
- Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca, 37007
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, 41013
- Recruiting
Hospital Universitario de Tarragona Juan XXIII
Tarragona, 43005
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, 46026
About this study
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.
Read the detailed description
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.
- Device thrombosis at 45-90 days, if suggested by Transesophageal Echocardiography (TEE), confirmed by a cardiac Computed Tomography (cCT) scan.
- Device thrombosis at 1 year, if suggested by TEE, confirmed by a CT scan.
- Cardiovascular death at 12 months.
- Nonprocedural major bleeding events (Bleeding Research Academy Consortium [BARC] ≥3b) at 12 months.
- The composite of cardiovascular death, stroke, systemic embolism, and nonprocedural bleeding at 12 months.
- All-cause death at 12 months. This study has an steering Committee, an independent Data and Safety Monitoring Board (DSMB) and independent Clinical Events Committee (CEC).
- Conditions
- Atrial Fibrillation
- Being tested
- Single antiplatelet therapy (SAPT)
- Keywords
- Left Atrial Appendage Closure, Single Antiplatelet Therapy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Single Antiplatelet therapy after Left Atrial Appendage Occlusion (LAAO) | Not described Receives: Drug: Single antiplatelet therapy (SAPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of stroke
A composite of stroke (including ischemic and/or hemorrhagic) and/or systemic embolism
Measured: 12 month
Secondary outcomes (6)
Device thrombosis
Freedom from device thrombosis by Echocardiography (TEE), confirmed by a cardiac Computed Tomography (CT) scan
Measured: 45 days to 90 days
Device thrombosis
Freedom from device thrombosis by Transesophageal Echocardiography (TEE), confirmed by a cardiac Computed Tomography (CT) scan
Measured: 12 months
Cardiovascular death
Freedom of Cardiovascular death
Measured: 12 months
Major bleeding
Freedom from major bleeding events according to Academy Consortium [BARC] ≥3b)
Measured: 12 months
Composite of cardiovascular death
Freedom from stroke, systemic embolism, and nonprocedural bleeding
Measured: 12 months
All cause of death
Freedom from All cause of death
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Oct 2024
- Primary completion10 Oct 2027 (estimated)
- Study completion20 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620757
- Sponsor's protocol ID
- EPIC39-S-SAPT LAMBRE
- Acronym
- S-SAPT LAMBRE
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32860505Krijthe 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.
PubMed 23900699Michaud GF, Stevenson WG. Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):353-361. doi: 10.1056/NEJMcp2023658. No abstract available.
PubMed 33503344Alkhouli 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.
PubMed 38939465Glikson 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.
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.
PubMed 35512858Carvalho 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.
PubMed 37611779Korsholm 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.
PubMed 27973336Park 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.
PubMed 29885707Llagostera-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.
PubMed 37879431
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06620757
- Acronym / sponsor ID
- S-SAPT LAMBRE / EPIC39-S-SAPT LAMBRE
- Conditions
- Atrial Fibrillation
- Keywords
- Left Atrial Appendage Closure, Single Antiplatelet Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 20 Oct 2027 (estimated)
- First posted
- 1 Oct 2024 (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.
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.
Detailed description
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.
- Device thrombosis at 45-90 days, if suggested by Transesophageal Echocardiography (TEE), confirmed by a cardiac Computed Tomography (cCT) scan.
- Device thrombosis at 1 year, if suggested by TEE, confirmed by a CT scan.
- Cardiovascular death at 12 months.
- Nonprocedural major bleeding events (Bleeding Research Academy Consortium [BARC] ≥3b) at 12 months.
- The composite of cardiovascular death, stroke, systemic embolism, and nonprocedural bleeding at 12 months.
- All-cause death at 12 months. This study has an steering Committee, an independent Data and Safety Monitoring Board (DSMB) and independent Clinical Events Committee (CEC).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Antiplatelet therapy after Left Atrial Appendage Occlusion (LAAO) | – | Drug: Single antiplatelet therapy (SAPT) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- No exclusion criteria must be met.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single antiplatelet therapy (SAPT)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 | Drug | Single Antiplatelet therapy after Left Atrial Appendage Occlusion (LAAO) |
Primary outcome
Composite of stroke
Time frame: 12 month
A composite of stroke (including ischemic and/or hemorrhagic) and/or systemic embolism
6 secondary outcomes
Device thrombosis
Time frame: 45 days to 90 days
Device thrombosis
Time frame: 12 months
Cardiovascular death
Time frame: 12 months
Major bleeding
Time frame: 12 months
Composite of cardiovascular death
Time frame: 12 months
All cause of death
Time frame: 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Background: PubMed 32860505Hindricks 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.
- Background: PubMed 23900699Krijthe 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.
- Background: PubMed 33503344Michaud GF, Stevenson WG. Atrial Fibrillation. N Engl J Med. 2021 Jan 28;384(4):353-361. doi: 10.1056/NEJMcp2023658. No abstract available.
- Background: PubMed 38939465Alkhouli 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.
- BackgroundGlikson 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: PubMed 35512858Freeman 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.
- Background: PubMed 37611779Carvalho 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.
- Background: PubMed 27973336Korsholm 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.
- Background: PubMed 29885707Park 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.
- Background: PubMed 37879431Llagostera-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.
- Individual participant dataSharing planned: No
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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.
22 sites 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 Fundación EPIC at 22 sites in Spain.
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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BEATRIZ VAQUERIZO, MD, PhD (0034987876135, bvaquerizo@psmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of stroke (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06620757, which also lists 10 linked publications.
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 14 Oct 2026.