Overview
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.
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).
Eligibility
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.