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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
Full description
Background:
Transcatheter left atrial appendage closure (LAAC) has been shown to be non-inferior to oral anticoagulation in preventing cardioembolic strokes associated with atrial fibrillation. However, an optimal antithrombotic treatment regimen following successful LAAC remains an unresolved issue. The scope and duration of antiplatelet treatment following LAAC are of paramount importance as they may significantly contribute to post-procedural as well as long-term procedural safety and efficacy.
Objective:
SAFE-LAAC Trial has been designed as a comparative health effectiveness study with the following aims:
Patient population:
Patients (n=200) after successful LAAC with Amplatzer or WATCHMAN device.
Perspective:
Results of this pilot trial will provide: 1. data to aid practitioners and guideline writers recommend the most optimal antithrombotic treatment after LAAC, and 2. data to support power calculations for designing future randomized trials.
Methodology:
SAFE LAAC has been designed as a multicenter (planned contribution of 7 centers in Poland), open-label, comparative health effectiveness trial with central, independent adjudication of events comprising the primary end-point. The first part of the trial is randomized and after 6 months of follow-up continues for another 12 months as a non-randomized study.
Timeline:
The duration of the trial has been planned for 5 years. The enrollment phase has been planned for 3 years.
Enrollment
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Interventional model
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200 participants in 4 patient groups
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Central trial contact
Radoslaw Pracon, MD PhD; Marcin Demkow, MD PhD
Data sourced from clinicaltrials.gov
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