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

NCT ID: NCT06177704

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2028-01-01

Brief 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.

Detailed Description

BACKGROUND: Percutaneous left atrial appendage occlusion (LAAO) has emerged as a nonpharmacological alternative for stroke prevention in patients with non-valvular atrial fibrillation ineligible for chronic anticoagulation therapy. Large real-world observational studies have consistently reported the efficacy of LAAO in reducing the risk of ischemic stroke and systemic embolism, compared to predicted rates, without the need for anticoagulants. Despite ongoing refinement in LAAO procedural technique, significant challenges persist. Notably, device-related thrombus (DRT) remains the main concern after LAAO. The reported incidence rate varies, ranging from 3% to 7%, and has been associated with an elevated risk of ischemic stroke and all-cause death following LAAO. Several risk factors have been identified with DRT occurrence, most of which are non-modifiable. The diagnosis of DRT is followed by an intensification of the antithrombotic treatment. However, not all DRT are resolved, with a significant number persisting or recurring upon withdrawal of anticoagulation therapy. In these situations, the antithrombotic treatment must be maintained, increasing the risk of bleeding, and mitigating the potential benefits of LAAO.

Both persistent and recurrent DRT have been linked to an increased risk of thromboembolic events when compared to resolved DRT. In the pooled analysis of data from the PROTECT-AF and PREVAIL trials, around 12% of embolic events in patients with DRT occurred in the presence of multiple DRT episodes. The incidence of persistent DRT has been reported in one out of three patients diagnosed with DRT, with DRT recurrence occurring in one out of five patients. However, the real incidence of persistent and recurrent DRT is uncertain, as current data come from retrospective studies with non-standardized imaging follow-up protocols. This situation leads to a significant number of missed cases, increases the risk of bias, and likely underestimates the rate of persistent and recurrent DRT. The timing of the imaging follow-up can significantly affect the incidence of DRT. In consecutive patients examined through a pre-specified protocol, the incidence of specific findings would be much more accurate compared to imaging examinations based exclusively on a single adverse clinical event, where the real incidence and clinical associations cannot be accurately determined.

The EHRA/EAPCI expert LAAO statement recommends imaging within 6-24 weeks and then 12 months post-procedure, with no mention of imaging follow-up in case of persistent or recurrent DRT. In contrast, the recent SCAI/HRS expert consensus statement on transcatheter LAAO suggests that repeat imaging at 45- to 90-day intervals can be conducted to assess for DRT resolution and consider the eventual cessation of anticoagulation, although there is no evidence that support this recommendation. Finally, considering the substantial rate of recurrent DRT and its clinical implications, a long-term and sequential imaging follow-up strategy may be warranted. Therefore, there is an unmet need for dedicated prospective data to determine the real incidence, related factors, and clinical impact of persistent and recurrent DRT after LAAO.

Conditions

Percutaneous Left Atrial Appendage Occlusion (LAAO); Device-related Thrombus (DRT); Thromboembolic Event; Major Cardioembolic Events; Major Bleeding - TIMI Classification

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with diagnosis of probable/definite DRT after LAAO

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

In all patients after the LAAO procedure, a first imaging evaluation at 45 to 90 days, and a second imaging evaluation at 12 months is recommended.

In case of DRT diagnosis, and following the recent SCAI/HRS recommendations, a repeat imaging at 45- to 90-day intervals is recommended to assess for DRT resolution with eventual cessation of anticoagulation.

In case of DRT resolution, a sequential imaging evaluation at ±90-day, ±180-day, and ±365 days after the imaging test where DRT was resolved is recommended

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with diagnosis of probable/definite DRT after LAAO detected by transesophageal echocardiography (TEE) or cardiac computed tomography (CT).
• Age≥18 years old.

Exclusion Criteria

• Unable to provide informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

OTHER

Sponsor Role: lead

Responsible Party

Josep Rodes-Cabau

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IUCPQ-UL

Québec, Quebec, Canada

Countries

Canada

Central Contacts

Josep Rodes-Cabau, MD, PhD

Role: CONTACT

josep.rodes@criucpq.ulaval.ca

14186568711

Melanie Cote, MSc

Role: CONTACT

melanie.cote@criucpq.ulaval.ca

14186568711

Facility Contacts

Melanie Cote

Role: primary

melanie.cote@criucpq.ulaval.ca

4186568711 ext. 2646

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Other Identifiers

RE-DRT

Identifier Type: -

Identifier Source: org_study_id