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RECRUITING
NCT03445949
PHASE4

Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure

Sponsor: National Institute of Cardiology, Warsaw, Poland

View on ClinicalTrials.gov

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 or WATCHMAN device

Official title: Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events Following Left Atrial Appendage Closure (SAFE-LAAC). Comparative Health Effectiveness Randomized Trial - PILOT Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2018-01-23

Completion Date

2027-06-23

Last Updated

2023-07-11

Healthy Volunteers

No

Interventions

DRUG

short postimplantation dual antiplatelet therapy

continuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer or WATCHMAN device

DRUG

extended postimplantation dual antiplatelet therapy

stopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer or WATCHMAN device

DRUG

long-term treatment with a single antiplatelet agent

continuing long-term treatment with single antiplatelet agent

DRUG

6 months treatment with a single antiplatelet agent

continuing single antiplatelet agent up until 6 months

Locations (1)

National Institute of Cardiology

Warsaw, Masovian Voivodeship, Poland