Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-27 @ 1:27 PM
Study NCT ID:
NCT06620757
Status:
RECRUITING
Last Update Posted:
2025-07-04
First Post:
2024-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Fundación EPIC
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
S-SAPT LAMBRE
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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: