Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177704
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-12-11
Brief Title:
Recurrent or Persistent Device Related Thrombus After Left Atrial Appendage Occlusion The RE-DRT Study
Sponsor:
Institut universitaire de cardiologie et de pneumologie de Québec University Laval
Organization:
Institut universitaire de cardiologie et de pneumologie de Québec University Laval
Study Overview
Official Title:
Recurrent or Persistent Device Related Thrombus After Left Atrial Appendage Occlusion The RE-DRT Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RE-DRT
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 EHRAEAPCI suggests imaging at specific intervals post-procedure while the SCAIHRS 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
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 EHRAEAPCI suggests imaging at specific intervals post-procedure while the SCAIHRS 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 EHRAEAPCI 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 SCAIHRS 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
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 EHRAEAPCI 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 SCAIHRS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None