Last updated on March 2018

Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure


Brief description of study

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

Detailed Study 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, optimal antithrombotic treatment regimen following successful LAAC remains an unresolved issue. The scope and duration of antiplatelet treatment following LAAC is of paramount importance as it 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 heath effectiveness study with the following aims:

  1. compare safety and efficacy of 30 days vs. 6 months of dual antiplatelet therapy following LAAC with Amplatzer Amulet device (randomized comparison)
  2. compare safety and efficacy of stopping all antithrombotic and antiplatelet agents 6 months after LAAC vs. long-term treatment with single antiplatelet agent (nonrandomized comparison)

Patient population:

Patients (n=160) with contraindications to oral anticoagulation, after successful LAAC with Amplatzer Amulet device.

Perspective

Results of this pilot trial will provide: 1. data to aid practitioners and guideline writers recommend 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 (4-5 centers in Poland), open-label, comparative heath effectiveness trial with central, independent adjudication of events comprising 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 3 years. The enrollment phase will continue over 1.5 years and follow up will extend to 3 years.

Clinical Study Identifier: NCT03445949

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Recruitment Status: Open


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