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Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure

NCT03445949 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-07-11

No results posted yet for this study

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

Conditions

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

Sponsors & Collaborators

  • Medical Research Agency, Poland

    collaborator OTHER_GOV

  • National Institute of Cardiology, Warsaw, Poland

    lead OTHER

Principal Investigators

  • Radoslaw Pracon, MD PhD · Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland

  • Marcin Demkow, MD PhD · Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-23
Primary Completion
2025-06-23
Completion
2027-06-23

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03445949 on ClinicalTrials.gov