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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with diagnosis of probable/definite DRT after LAAO detected by transesophageal echocardiography (TEE) or cardiac computed tomography (CT).

Age≥18 years old.

Disqualifiers

Unable to provide informed consent

Trial population

Patients undergoing LAAO with a probable/definite diagnosis of DRT detected by transesophageal echocardiography (TEE) or cardiac computed tomography (CT).

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Patients with diagnosis of probable/definite DRT after LAAO

Trial outcomes

Primary outcomes

1

Thromboembolic events (ischemic stroke, systemic embolism)

Incidence of and thromboembolic events (ischemic stroke, systemic embolism) associated with persistent/recurrent DRT after LAAO

Time frame
1-month, 6-month, 1-year, 2-year

Secondary outcomes

Other outcomes

Sponsors and contacts

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