Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620757
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
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:
None
Organization:
None
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:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 AFAtrial Fibrillation with a CHA2DS2-VASc score 2 men or 3 women and contraindication for long-term anticoagulant treatment with successful LAAC Left Atrial Appendage Closureprocedure 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 andor hemorrhagic andor 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 andor hemorrhagic andor 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None