Safety and Effectiveness of Short-Term Single AntiPlatelet Therapy After Left Atrial Appendage Cl… (NCT06620757) | Clinical Trial Compass
RecruitingNot Applicable
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
Spain234 participantsStarted 2024-10-10
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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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 discont…