Recurrent or Persistent Device Related Thrombus After Left Atrial Appendage Occlusion: The RE-DRT Study

Condition(s) studied

Study summary

This study is a prospective, multicenter international trial aimed at assessing the actual incidence, identifying associated factors, and evaluating the clinical consequences of both persistent and recurrent device-related thrombus (DRT) following percutaneous left atrial appendage occlusion (LAAO).

While LAAO has shown efficacy in reducing the risk of stroke, device-related thrombus (DRT) remains a significant concern. The reported incidence of DRT varies, and it is associated with an elevated risk of ischemic stroke and death. The study highlights that persistent and recurrent DRT pose higher risks of thromboembolic events, and current data come from retrospective studies with non-standardized imaging follow-up protocols. The timing of imaging follow-up is crucial, and the study notes discrepancies in recommendations from expert statements. The EHRA/EAPCI suggests imaging at specific intervals post-procedure, while the SCAI/HRS recommends repeat imaging at shorter intervals to assess DRT resolution. The study underscores the need for dedicated prospective data to accurately determine the incidence, factors, and clinical impact of persistent and recurrent DRT after LAAO.

Eligibility

Primary outcome measure(s)

• Thromboembolic events (ischemic stroke, systemic embolism) — 1-month, 6-month, 1-year, 2-year
  Incidence of and thromboembolic events (ischemic stroke, systemic embolism) associated with persistent/recurrent DRT after LAAO

Trial sites (1)

More Institut universitaire de cardiologie et de pneumologie de Québec, University Laval trials in Canada