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

NCT06177704 | Not Yet Recruiting

• 1 other identifier: RE-DRT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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

  1-month, 6-month, 1-year, 2-year

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: lead

Study Sites (1)

IUCPQ-UL

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (13)

• Mesnier J, Simard T, Jung RG, Lehenbauer KR, Piayda K, Pracon R, Jackson GG, Flores-Umanzor E, Faroux L, Korsholm K, Chun JKR, Chen S, Maarse M, Montrella K, Chaker Z, Spoon JN, Pastormerlo LE, Meincke F, Sawant AC, Moldovan CM, Qintar M, Aktas MK, Branca L, Radinovic A, Ram P, El-Zein RS, Flautt T, Ding WY, Sayegh B, Benito-Gonzalez T, Lee OH, Badejoko SO, Paitazoglou C, Karim N, Zaghloul AM, Agarwal H, Kaplan RM, Alli O, Ahmed A, Suradi HS, Knight BP, Alla VM, Panaich SS, Wong T, Bergmann MW, Chothia R, Kim JS, Perez de Prado A, Bazaz R, Gupta D, Valderrabano M, Sanchez CE, El Chami MF, Mazzone P, Adamo M, Ling F, Wang DD, O'Neill W, Wojakowski W, Pershad A, Berti S, Spoon DB, Kawsara A, Jabbour G, Boersma LVA, Schmidt B, Nielsen-Kudsk JE, Freixa X, Ellis CR, Fauchier L, Demkow M, Sievert H, Main ML, Hibbert B, Holmes DR Jr, Alkhouli M, Rodes-Cabau J. Persistent and Recurrent Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes. JACC Cardiovasc Interv. 2023 Nov 27;16(22):2722-2732. doi: 10.1016/j.jcin.2023.09.017.

  PMID: 38030358 BACKGROUND

• Saw J, Holmes DR, Cavalcante JL, Freeman JV, Goldsweig AM, Kavinsky CJ, Moussa ID, Munger TM, Price MJ, Reisman M, Sherwood MW, Turi ZG, Wang DD, Whisenant BK. SCAI/HRS expert consensus statement on transcatheter left atrial appendage closure. Heart Rhythm. 2023 May;20(5):e1-e16. doi: 10.1016/j.hrthm.2023.01.007. Epub 2023 Mar 27.

  PMID: 36990925 BACKGROUND

• Tzikas A, Holmes DR Jr, Gafoor S, Ruiz CE, Blomstrom-Lundqvist C, Diener HC, Cappato R, Kar S, Lee RJ, Byrne RA, Ibrahim R, Lakkireddy D, Soliman OI, Nabauer M, Schneider S, Brachmann J, Saver JL, Tiemann K, Sievert H, Camm AJ, Lewalter T. Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies. Europace. 2017 Jan;19(1):4-15. doi: 10.1093/europace/euw141. Epub 2016 Aug 18.

  PMID: 27540038 BACKGROUND

• Holmes DR Jr, Korsholm K, Rodes-Cabau J, Saw J, Berti S, Alkhouli MA. Left atrial appendage occlusion. EuroIntervention. 2023 Feb 6;18(13):e1038-e1065. doi: 10.4244/EIJ-D-22-00627.

  PMID: 36760206 RESULT

• Holmes DR Jr, Reddy VY, Gordon NT, Delurgio D, Doshi SK, Desai AJ, Stone JE Jr, Kar S. Long-Term Safety and Efficacy in Continued Access Left Atrial Appendage Closure Registries. J Am Coll Cardiol. 2019 Dec 10;74(23):2878-2889. doi: 10.1016/j.jacc.2019.09.064.

  PMID: 31806131 RESULT

• Simard TJ, Hibbert B, Alkhouli MA, Abraham NS, Holmes DR Jr. Device-related thrombus following left atrial appendage occlusion. EuroIntervention. 2022 Jun 24;18(3):224-232. doi: 10.4244/EIJ-D-21-01010.

  PMID: 35440430 RESULT

• Alkhouli M, Alarouri H, Kramer A, Korsholm K, Collins J, De Backer O, Hatoum H, Nielsen-Kudsk JE. Device-Related Thrombus After Left Atrial Appendage Occlusion: Clinical Impact, Predictors, Classification, and Management. JACC Cardiovasc Interv. 2023 Nov 27;16(22):2695-2707. doi: 10.1016/j.jcin.2023.10.046.

  PMID: 38030357 RESULT

• Alkhouli M, Busu T, Shah K, Osman M, Alqahtani F, Raybuck B. Incidence and Clinical Impact of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion: A Meta-Analysis. JACC Clin Electrophysiol. 2018 Dec;4(12):1629-1637. doi: 10.1016/j.jacep.2018.09.007. Epub 2018 Nov 1.

  PMID: 30573129 RESULT

• Mesnier J, Cepas-Guillen P, Freixa X, Flores-Umanzor E, Hoang Trinh K, O'Hara G, Rodes-Cabau J. Antithrombotic Management After Left Atrial Appendage Closure: Current Evidence and Future Perspectives. Circ Cardiovasc Interv. 2023 May;16(5):e012812. doi: 10.1161/CIRCINTERVENTIONS.122.012812. Epub 2023 May 16.

  PMID: 37192309 RESULT

• Asmarats L, Cruz-Gonzalez I, Nombela-Franco L, Arzamendi D, Peral V, Nietlispach F, Latib A, Maffeo D, Gonzalez-Ferreiro R, Rodriguez-Gabella T, Agudelo V, Alamar M, Ghenzi RA, Mangieri A, Bernier M, Rodes-Cabau J. Recurrence of Device-Related Thrombus After Percutaneous Left Atrial Appendage Closure. Circulation. 2019 Oct 22;140(17):1441-1443. doi: 10.1161/CIRCULATIONAHA.119.040860. Epub 2019 Oct 21. No abstract available.

  PMID: 31634013 RESULT

• Sedaghat A, Vij V, Al-Kassou B, Gloekler S, Galea R, Furholz M, Meier B, Valgimigli M, O'Hara G, Arzamendi D, Agudelo V, Asmarats L, Freixa X, Flores-Umanzor E, De Backer O, Sondergaard L, Nombela-Franco L, McInerney A, Korsholm K, Nielsen-Kudsk JE, Afzal S, Zeus T, Operhalski F, Schmidt B, Montalescot G, Guedeney P, Iriart X, Miton N, Saw J, Gilhofer T, Fauchier L, Veliqi E, Meincke F, Petri N, Nordbeck P, Rycerz S, Ognerubov D, Merkulov E, Cruz-Gonzalez I, Gonzalez-Ferreiro R, Bhatt DL, Laricchia A, Mangieri A, Omran H, Schrickel JW, Rodes-Cabau J, Nickenig G. Device-Related Thrombus After Left Atrial Appendage Closure: Data on Thrombus Characteristics, Treatment Strategies, and Clinical Outcomes From the EUROC-DRT-Registry. Circ Cardiovasc Interv. 2021 May;14(5):e010195. doi: 10.1161/CIRCINTERVENTIONS.120.010195. Epub 2021 May 18.

  PMID: 34003661 RESULT

• Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4.

  PMID: 29103847 RESULT

• Glikson M, Wolff R, Hindricks G, Mandrola J, Camm AJ, Lip GYH, Fauchier L, Betts TR, Lewalter T, Saw J, Tzikas A, Sternik L, Nietlispach F, Berti S, Sievert H, Bertog S, Meier B; ESC Scientific Document Group. EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion - an update. Europace. 2020 Feb 1;22(2):184. doi: 10.1093/europace/euz258. Epub 2019 Aug 31. No abstract available.

  PMID: 31504441 RESULT

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Josep Rodes-Cabau, MD, PhD

CONTACT

14186568711; josep.rodes@criucpq.ulaval.ca

Melanie Cote, MSc

CONTACT

14186568711; melanie.cote@criucpq.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

CA (1)