Percutaneous Left Atrial Appendage Occlusion (LAAO)RE-DRTNCT06177704
Recurrent or Persistent Device Related Thrombus After Left Atrial Appendage Occlusion: The RE-DRT Study
An observational study of Percutaneous Left Atrial Appendage Occlusion (LAAO) and Device-related Thrombus (DRT), run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Left Atrial Appendage Occlusion (LAAO), Device-related Thrombus (DRT), Thromboembolic Event
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2026to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing LAAO with a probable/definite diagnosis of DRT detected by transesophageal echocardiography (TEE) or cardiac computed tomography (CT).
Who may be able to join
- Patients with diagnosis of probable/definite DRT after LAAO detected by transesophageal echocardiography (TEE) or cardiac computed tomography (CT).
- Age≥18 years old.
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
IUCPQ-UL
Québec, Quebec, G1V 4G5
Melanie Cote, 4186568711 ext. 2646, melanie.cote@criucpq.ulaval.ca
About this study
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.
Read the 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
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboembolic events (ischemic stroke, systemic embolism)
Incidence of and thromboembolic events (ischemic stroke, systemic embolism) associated with persistent/recurrent DRT after LAAO
Measured: 1-month, 6-month, 1-year, 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Left Atrial Appendage Occlusion (LAAO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Rodes-Cabau, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177704
- Sponsor's protocol ID
- RE-DRT
- Acronym
- RE-DRT
- Status last verified
- Mar 2026
- First submitted
- 11 Dec 2023
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38030358Saw 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.
PubMed 36990925Tzikas 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.
PubMed 27540038Holmes 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.
PubMed 36760206Holmes 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.
PubMed 31806131Simard 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.
PubMed 35440430Alkhouli 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.
PubMed 38030357Alkhouli 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.
PubMed 30573129Mesnier 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.
PubMed 37192309Asmarats 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.
PubMed 31634013Sedaghat 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.
PubMed 34003661Reddy 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.
PubMed 29103847Glikson 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.
PubMed 31504441
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent or Persistent Device Related Thrombus After Left Atrial Appendage Occlusion: The RE-DRT Study
- ClinicalTrials.gov ID
- NCT06177704
- Acronym / sponsor ID
- RE-DRT / RE-DRT
- Conditions
- Percutaneous Left Atrial Appendage Occlusion (LAAO), Device-related Thrombus (DRT), Thromboembolic Event, Major Cardioembolic Events, Major Bleeding - TIMI Classification
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University LavalUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing LAAO with a probable/definite diagnosis of DRT detected by transesophageal echocardiography (TEE) or cardiac computed tomography (CT).
Key inclusion criteria (2 listed)
- Patients with diagnosis of probable/definite DRT after LAAO detected by transesophageal echocardiography (TEE) or cardiac computed tomography (CT).
- Age≥18 years old.
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thromboembolic events (ischemic stroke, systemic embolism)
Time frame: 1-month, 6-month, 1-year, 2-year
Incidence of and thromboembolic events (ischemic stroke, systemic embolism) associated with persistent/recurrent DRT after LAAO
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Background: PubMed 38030358Mesnier 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.
- Background: PubMed 36990925Saw 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.
- Background: PubMed 27540038Tzikas 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.
- Results publication: PubMed 36760206Holmes 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.
- Results publication: PubMed 31806131Holmes 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.
- Results publication: PubMed 35440430Simard 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.
- Results publication: PubMed 38030357Alkhouli 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.
- Results publication: PubMed 30573129Alkhouli 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.
- Results publication: PubMed 37192309Mesnier 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.
- Results publication: PubMed 31634013Asmarats 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.
- Results publication: PubMed 34003661Sedaghat 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.
- Results publication: PubMed 29103847Reddy 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.
Related trials for Percutaneous Left Atrial Appendage Occlusion (LAAO)
Recruiting
LAAO Versus NOAC in Patients with AF and PCI
Atrial Fibrillation, Percutaneous Coronary Intervention
Not yet recruiting
Surgical vs Percutaneous LAAO
Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Left Atrial Appendage Occlusion (LAAO) and Device-related Thrombus (DRT), run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josep Rodes-Cabau, MD, PhD (14186568711, josep.rodes@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thromboembolic events (ischemic stroke, systemic embolism) (time frame: 1-month, 6-month, 1-year, 2-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06177704, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.