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
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Spain
Hospital Universitario A Coruña
RECRUITING
A Coruña
Hospital Clínico San Carlos
RECRUITING
Aravaca
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Del Mar
RECRUITING
Barcelona
Hospital Universitari Vall D'Hebron
RECRUITING
Barcelona
Hospital Universitario Reina Sofía de Córdoba
RECRUITING
Córdoba
Hospital Universitario La Paz
RECRUITING
Fuencarral-el Pardo
Hospital Universitario de Cabueñes
RECRUITING
Gijón
Hospital Universitario de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario de Gran Canaria Doctor Negrín
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario de Leon
RECRUITING
León
Hospital Universitari Arnau de Vilanova
RECRUITING
Lleida
Hospital Central de La Defensa Gómez Ulla
RECRUITING
Madrid
Hospital Universitario Puerta De Hierro
RECRUITING
Majadahonda
Hospital Regional Universitario de Málaga
RECRUITING
Málaga
Hospital de Manises
RECRUITING
Manises
Hospital Universitario Son Espases
RECRUITING
Palma De Mallorca
Hospital Clínico Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Hospital Universitario de Tarragona Juan XXIII
RECRUITING
Tarragona
Hospital Universitario y Politécnico La Fe
RECRUITING
Valencia
Contact Information
Primary
BEATRIZ VAQUERIZO, MD, PhD
bvaquerizo@psmar.cat
0034987876135
Backup
FUNDACION EPIC
iepic@fundacionepic.org
34987876135
Time Frame
Start Date: 2024-10-10
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 234
Treatments
Single Antiplatelet therapy after Left Atrial Appendage Occlusion (LAAO)
Related Therapeutic Areas
Sponsors
Leads: Fundación EPIC

This content was sourced from clinicaltrials.gov