Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

SAFE-LAAC Trial has been designed to gather data on the most optimal strategy of antiplatelet therapy after transcatheter left atrial appendage occlusion with Amplatzer Amulet device

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Cardiology, Warsaw, Poland

Criteria

Inclusion Criteria:

• successful left atrial appendage occlusion with Amulet device within 37 days prior to randomization.

• treatment with dual antiplatelet therapy (clopidogrel and acetylsalicylic acid) between left atrial appendage closure and randomization

• participant's age 18 years or older at the time of signing the informed consent form

• participant is willing to follow all study procedures; especially randomized antiplatelet treatment regimen and follow-up visits with transesophageal echocardiography when applicable

• participant is willing to sign the study informed consent form

Exclusion Criteria:

• indications to dual antiplatelet therapy other than atrial fibrillation or left atrial appendage occlusion at the time of enrollment or predicted appearance of such indications within the duration of the trial (eg. coronary artery disease)

• indications to anticoagulation at the time of enrollment or predicted appearance of such indications within the duration of the trial (eg. pulmonary embolism)

• known allergy to clopidogrel or acetylsalicylic acid precluding its administration as specified by the protocol

• any known inborn or acquired coagulation disorders

• poor tolerance of or technical difficulties with performing transesophageal echocardiography

• peridevice leak >5mm on transesophageal echocardiography study preceding enrollment

• left atrial thrombus on transesophageal echocardiography study performed after successful left atrial appendage closure but before enrollment

• life expectancy of less than 18months

• participation in other clinical studies with experimental therapies at the time of enrollment and preceding 3 months

• chronic kidney disease stage IV and V

• women who are pregnant or breast feeding; women of childbearing potential who do not consent to apply at least to methods of contraception. This criterion does not apply to postmenopausal women