Clinical trial NCT06620757: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: Left Atrial Appendage Closure
Single Antiplatelet Therapy
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

1. Device thrombosis at 45-90 days, if suggested by Transesophageal Echocardiography (TEE), confirmed by a cardiac Computed Tomography (cCT) scan.
2. Device thrombosis at 1 year, if suggested by TEE, confirmed by a CT scan.
3. Cardiovascular death at 12 months.
4. Nonprocedural major bleeding events (Bleeding Research Academy Consortium \[BARC\] ≥3b) at 12 months.
5. The composite of cardiovascular death, stroke, systemic embolism, and nonprocedural bleeding at 12 months.
6. 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).

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.).
* 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.

Primary outcomes:
measure: Composite of stroke
timeFrame: 12 month
Secondary outcomes:
measure: Device thrombosis
timeFrame: 45 days to 90 days
measure: Device thrombosis
timeFrame: 12 months
measure: Cardiovascular death
timeFrame: 12 months
measure: Major bleeding
timeFrame: 12 months
measure: Composite of cardiovascular death
timeFrame: 12 months
measure: All cause of death
timeFrame: 12 month
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Aravaca
country: Spain
facility: Hospital Clínico San Carlos
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía de Córdoba
city: Fuencarral-El Pardo
country: Spain
facility: Hospital Universitario La Paz
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
city: León
country: Spain
facility: Hospital Universitario de Leon
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Central de La Defensa Gómez Ulla
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta De Hierro
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Tarragona
country: Spain
facility: Hospital Universitario de Tarragona Juan XXIII
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
References:
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