Left Atrial Appendage ClosurePhase 4ANDESNCT03568890

Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure

A Phase 4 study testing Rivaroxaban, dabigatran, apixaban, or edoxaban, Clopidogrel -75 mg/day and Low dose aspirin -80 to 125 mg/day- in people with Left Atrial Appendage Closure and Thrombosis, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

The objective of the study is to compare short-term (8 weeks) anticoagulation therapy (DOAC) vs. antiplatelet therapy for the prevention of device thrombosis following transcatheter LAAC. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Left Atrial Appendage Closure, Thrombosis, Stroke
What is being tested?: Rivaroxaban, dabigatran, apixaban, or edoxaban, Clopidogrel -75 mg/day and Low dose aspirin -80 to 125 mg/day-
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 510 participants
Where: 1 siteCanada
Study dates: 1 Sep 2018to 1 Sep 2030
Phase: Phase 4
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Successful transcatheter LAAC with any approved device
Age≥18 years old

Who cannot join

Absolute contraindications for anticoagulation therapy
Absolute contraindications for antiplatelet therapy
End-stage renal disease (CrCl <15 ml/min)
Recent percutaneous revascularization with drug-eluting stents requiring dual antiplatelet therapy
Prior intracranial hemorrhage
Contraindications for TEE

Show all 10Show fewer

Severe pericardial effusion within the first 24 hrs following LAAC
Major/life-threatening bleeding event within the month prior to LAAC
Multiple bleeding events (minor or major) within the month prior to LAAC
Major/life-threatening bleeding within the first 24 hrs following LAAC

Trial locations and contacts

1 site in 1 country.

Canada1 site

Josep Rodes-Cabau
Québec, Quebec, G1V 4G5

Other trials in Canada

About this study

Official title: Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure. The ANDES Trial

The objective of the study is to compare short-term (8 weeks) anticoagulation therapy (DOAC) vs. antiplatelet therapy for the prevention of device thrombosis following transcatheter LAAC.

Read the detailed description

Transcatheter left atrial appendage closure (LAAC) has emerged as an alternative to anticoagulation for preventing thromboembolic events in patients with atrial fibrillation. Whereas most complications associated with LAAC have decreased over time, the occurrence of device thrombosis remains a concern, with an incidence of 1 to 17%. Antithrombotic therapy for preventing device thrombosis following LAAC has evolved empirically, with antiplatelet therapy being the most commonly prescribed treatment. However, the rates of device thrombosis post-LAAC remain relatively high and have not decreased over time despite of increasing operator/center experience and the arrival of newer generation devices. This is of particular concern if we consider that LAAC is a preventive treatment. Experimental and mechanistic studies have suggested enhanced thrombin generation (and not platelet activation) within the days-weeks following the procedure as the most important mechanism involved in device thrombosis and appropriate short-term anticoagulation therapy with DOAC should translate into a significant reduction in the rate of device thrombosis post-LAAC.

Therefore, the objective of the study is to compare short-term (60 days) anticoagulation therapy (DOAC) vs. antiplatelet therapy for the prevention of device thrombosis following transcatheter LAAC.

It is estimated that 350 patients will take part in the study.

Update: A blinded interim analysis was performed with the analysis of clinical and TEE (central echo core lab) data from the initial 155 patients included in the study. Based on the results of the interim analysis, and considering the total number of events and the high rate (20%) of patients with either early cessation of the allocated treatment (before the 60-day TEE examination) or missing TEE at 60 days, it was decided to increase the sample size by 160 patients up to a total of 510 patients. This would ensure to include at least 350 patients with a TEE examination performed while receiving the allocated antithrombotic treatment.

Conditions: Left Atrial Appendage Closure, Thrombosis, Stroke, TIA, Bleeding
Being tested: Rivaroxaban, dabigatran, apixaban, or edoxaban, Clopidogrel -75 mg/day, Low dose aspirin -80 to 125 mg/day-
Keywords: Left Atrial Appendage Closure, Anticoagulation therapy, Antiplatelet therapy
Medical subject headings: Thrombosis, Stroke, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rivaroxaban, dabigatran, apixaban, or edoxabanDrug
Duration of treatment: 60 days
Clopidogrel -75 mg/dayDrug
Duration of treatment: 60 days
Low dose aspirin -80 to 125 mg/day-Drug
Duration of treatment: 60 days

Study groups in NCT03568890
Study group	Role	What they receive
Anticoagulation therapy	Active comparator	Direct oral anticoagulants (rivaroxaban, dabigatran, apixaban, or edoxaban; with dosage according to guideline recommendations) for 60 days. Receives: Drug: Rivaroxaban, dabigatran, apixaban, or edoxaban
Antiplatelet therapy	Active comparator	Dual antiplatelet therapy with clopidogrel -75 mg/day- and low dose aspirin -80 to 125 mg/day for 60 days. Receives: Drug: Clopidogrel -75 mg/day; Drug: Low dose aspirin -80 to 125 mg/day-

What is being measured

The primary outcome is the main question the study is designed to answer.

Device thrombosis (efficacy outcome)
Evaluated by TEE
Measured: 60 days after LAAC
Combined outcome of all-cause mortality, bleeding, stroke, or Device thrombosis (Safety outcome)
Clinically evaluated and diagnosed by the center investigators and determining a treatment change.
Measured: 60 days after LAAC

Secondary outcomes (5)

Device thrombosis
Evaluated by TEE or computed tomography
Measured: 12 months after LAAC
Ischemic events
Stroke, TIA
Measured: 60 days, 12-month, 2-year, 3-year, 4-year and 5-year follow-up
Bleeding events
Measured: 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up
Major or Life-threatening bleeding events
Measured: 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up
Mortality
All cause mortality
Measured: 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20181 Sep 2030

First posted26 Jun 2018
Study start1 Sep 2018
Primary completion1 Aug 2025
Study completion1 Sep 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Left Atrial Appendage ClosureStudies 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: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 510 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03568890
Sponsor's protocol ID: ANDES
Acronym: ANDES
Status last verified: Mar 2026
First submitted: 14 Jun 2018
Last updated: 27 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Asmarats L, Rodes-Cabau J. Percutaneous Left Atrial Appendage Closure: Current Devices and Clinical Outcomes. Circ Cardiovasc Interv. 2017 Nov;10(11):e005359. doi: 10.1161/CIRCINTERVENTIONS.117.005359.
PubMed 29146668
Main ML, Fan D, Reddy VY, Holmes DR, Gordon NT, Coggins TR, House JA, Liao L, Rabineau D, Latus GG, Huber KC, Sievert H, Wright RF, Doshi SK, Douglas PS. Assessment of Device-Related Thrombus and Associated Clinical Outcomes With the WATCHMAN Left Atrial Appendage Closure Device for Embolic Protection in Patients With Atrial Fibrillation (from the PROTECT-AF Trial). Am J Cardiol. 2016 Apr 1;117(7):1127-34. doi: 10.1016/j.amjcard.2016.01.039. Epub 2016 Feb 1.
PubMed 26993976
Saw J, Tzikas A, Shakir S, Gafoor S, Omran H, Nielsen-Kudsk JE, Kefer J, Aminian A, Berti S, Santoro G, Nietlispach F, Moschovitis A, Cruz-Gonzalez I, Stammen F, Tichelbacker T, Freixa X, Ibrahim R, Schillinger W, Meier B, Sievert H, Gloekler S. Incidence and Clinical Impact of Device-Associated Thrombus and Peri-Device Leak Following Left Atrial Appendage Closure With the Amplatzer Cardiac Plug. JACC Cardiovasc Interv. 2017 Feb 27;10(4):391-399. doi: 10.1016/j.jcin.2016.11.029.
PubMed 28231907
Tzikas A, Shakir S, Gafoor S, Omran H, Berti S, Santoro G, Kefer J, Landmesser U, Nielsen-Kudsk JE, Cruz-Gonzalez I, Sievert H, Tichelbacker T, Kanagaratnam P, Nietlispach F, Aminian A, Kasch F, Freixa X, Danna P, Rezzaghi M, Vermeersch P, Stock F, Stolcova M, Costa M, Ibrahim R, Schillinger W, Meier B, Park JW. Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. EuroIntervention. 2016 Feb;11(10):1170-9. doi: 10.4244/EIJY15M01_06.
PubMed 25604089
Lempereur M, Aminian A, Freixa X, Gafoor S, Kefer J, Tzikas A, Legrand V, Saw J. Device-associated thrombus formation after left atrial appendage occlusion: A systematic review of events reported with the Watchman, the Amplatzer Cardiac Plug and the Amulet. Catheter Cardiovasc Interv. 2017 Nov 1;90(5):E111-E121. doi: 10.1002/ccd.26903. Epub 2017 Feb 1.
PubMed 28145040
Fauchier L, Cinaud A, Brigadeau F, Lepillier A, Pierre B, Abbey S, Fatemi M, Franceschi F, Guedeney P, Jacon P, Paziaud O, Venier S, Deharo JC, Gras D, Klug D, Mansourati J, Montalescot G, Piot O, Defaye P. Device-Related Thrombosis After Percutaneous Left Atrial Appendage Occlusion for Atrial Fibrillation. J Am Coll Cardiol. 2018 Apr 10;71(14):1528-1536. doi: 10.1016/j.jacc.2018.01.076.
PubMed 29622159
O'Hara C, O'Hara GE, Jacques F, Champagne J, Lemyre M, Charbonneau L, O'Connor K, Bernier M, Beaudoin J, Rodes-Cabau J, Paradis JM. Run With the Hare and Hunt With the Hounds: Watchman Device Surgical Resection in the Setting of Recurrent Device Related Thrombi in a Patient With Bleeding Diathesis. JACC Cardiovasc Interv. 2016 Dec 12;9(23):e223-e225. doi: 10.1016/j.jcin.2016.09.041. No abstract available.
PubMed 27931603
Rodriguez-Gabella T, Nombela-Franco L, Regueiro A, Jimenez-Quevedo P, Champagne J, O'Hara G, Bernier M, Macaya C, Rodes-Cabau J. Single Antiplatelet Therapy Following Left Atrial Appendage Closure in Patients With Contraindication to Anticoagulation. J Am Coll Cardiol. 2016 Oct 25;68(17):1920-1921. doi: 10.1016/j.jacc.2016.08.016. No abstract available.
PubMed 27765196
Jalal Z, Dinet ML, Combes N, Pillois X, Renou P, Sibon I, Iriart X, Thambo JB. Percutaneous left atrial appendage closure followed by single antiplatelet therapy: Short- and mid-term outcomes. Arch Cardiovasc Dis. 2017 Apr;110(4):242-249. doi: 10.1016/j.acvd.2016.09.006. Epub 2017 Jan 3.
PubMed 28065447
Rodes-Cabau J, O'Hara G, Paradis JM, Bernier M, Rodriguez-Gabella T, Regueiro A, O'Connor K, Beaudoin J, Puri R, Cote M, Champagne J. Changes in Coagulation and Platelet Activation Markers Following Transcatheter Left Atrial Appendage Closure. Am J Cardiol. 2017 Jul 1;120(1):87-91. doi: 10.1016/j.amjcard.2017.03.253. Epub 2017 Apr 12.
PubMed 28495432
Schwartz RS, Holmes DR, Van Tassel RA, Hauser R, Henry TD, Mooney M, Matthews R, Doshi S, Jones RM, Virmani R. Left atrial appendage obliteration: mechanisms of healing and intracardiac integration. JACC Cardiovasc Interv. 2010 Aug;3(8):870-7. doi: 10.1016/j.jcin.2010.04.017.
PubMed 20723861
Bass JL. Transcatheter occlusion of the left atrial appendage--experimental testing of a new Amplatzer device. Catheter Cardiovasc Interv. 2010 Aug 1;76(2):181-5. doi: 10.1002/ccd.22536.
PubMed 20665856
Kar S, Hou D, Jones R, Werner D, Swanson L, Tischler B, Stein K, Huibregtse B, Ladich E, Kutys R, Virmani R. Impact of Watchman and Amplatzer devices on left atrial appendage adjacent structures and healing response in a canine model. JACC Cardiovasc Interv. 2014 Jul;7(7):801-9. doi: 10.1016/j.jcin.2014.03.003.
PubMed 25060026
January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):2071-104. doi: 10.1161/CIR.0000000000000040. Epub 2014 Mar 28. No abstract available.
PubMed 24682348
Verheugt FW, Granger CB. Oral anticoagulants for stroke prevention in atrial fibrillation: current status, special situations, and unmet needs. Lancet. 2015 Jul 18;386(9990):303-10. doi: 10.1016/S0140-6736(15)60245-8. Epub 2015 Mar 14.
PubMed 25777666

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
Not yet recruitingObservational study
Registry on Luma Vision's VERAFEYE System (ENLIgHT)
Atrial Fibrillation, Left Atrial Appendage Closure
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
RecruitingPhase 4
Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)
Atrial Fibrillation, Left Atrial Appendage Absent

All Left Atrial Appendage Closure trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure. The ANDES Trial
ClinicalTrials.gov ID: NCT03568890
Acronym / sponsor ID: ANDES / ANDES
Conditions: Left Atrial Appendage Closure, Thrombosis, Stroke, TIA, Bleeding
Keywords: Left Atrial Appendage Closure, Anticoagulation therapy, Antiplatelet therapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 510 participants (estimated)
Lead sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecUniversity, hospital or other
Study start: 1 Sep 2018 (actual)
Primary completion: 1 Aug 2025 (actual)
Study completion: 1 Sep 2030 (estimated)
First posted: 26 Jun 2018 (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.

The objective of the study is to compare short-term (8 weeks) anticoagulation therapy (DOAC) vs. antiplatelet therapy for the prevention of device thrombosis following transcatheter LAAC.

Detailed description

Therefore, the objective of the study is to compare short-term (60 days) anticoagulation therapy (DOAC) vs. antiplatelet therapy for the prevention of device thrombosis following transcatheter LAAC.

It is estimated that 350 patients will take part in the study.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Anticoagulation therapy	Active comparator	Drug: Rivaroxaban, dabigatran, apixaban, or edoxabanDirect oral anticoagulants (rivaroxaban, dabigatran, apixaban, or edoxaban; with dosage according to guideline recommendations) for 60 days.
Antiplatelet therapy	Active comparator	Drug: Clopidogrel -75 mg/day, Drug: Low dose aspirin -80 to 125 mg/day-Dual antiplatelet therapy with clopidogrel -75 mg/day- and low dose aspirin -80 to 125 mg/day for 60 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Successful transcatheter LAAC with any approved device
Age≥18 years old

Key exclusion criteria (10 listed)

Absolute contraindications for anticoagulation therapy
Absolute contraindications for antiplatelet therapy
End-stage renal disease (CrCl <15 ml/min)
Recent percutaneous revascularization with drug-eluting stents requiring dual antiplatelet therapy
Prior intracranial hemorrhage

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rivaroxaban, dabigatran, apixaban, or edoxabanDuration of treatment: 60 days	Drug	Anticoagulation therapy
Clopidogrel -75 mg/dayDuration of treatment: 60 days	Drug	Antiplatelet therapy
Low dose aspirin -80 to 125 mg/day-Duration of treatment: 60 days	Drug	Antiplatelet therapy

Primary outcome

Device thrombosis (efficacy outcome)
Time frame: 60 days after LAAC
Evaluated by TEE
Combined outcome of all-cause mortality, bleeding, stroke, or Device thrombosis (Safety outcome)
Time frame: 60 days after LAAC
Clinically evaluated and diagnosed by the center investigators and determining a treatment change.

5 secondary outcomes

Device thrombosis
Time frame: 12 months after LAAC
Ischemic events
Time frame: 60 days, 12-month, 2-year, 3-year, 4-year and 5-year follow-up
Bleeding events
Time frame: 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up
Major or Life-threatening bleeding events
Time frame: 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up
Mortality
Time frame: 60 days and 12-month, 2-year, 3-year, 4-year and 5-year follow-up

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 27 Mar 2026.
Results publication: PubMed 29146668Asmarats L, Rodes-Cabau J. Percutaneous Left Atrial Appendage Closure: Current Devices and Clinical Outcomes. Circ Cardiovasc Interv. 2017 Nov;10(11):e005359. doi: 10.1161/CIRCINTERVENTIONS.117.005359.
Results publication: PubMed 26993976Main ML, Fan D, Reddy VY, Holmes DR, Gordon NT, Coggins TR, House JA, Liao L, Rabineau D, Latus GG, Huber KC, Sievert H, Wright RF, Doshi SK, Douglas PS. Assessment of Device-Related Thrombus and Associated Clinical Outcomes With the WATCHMAN Left Atrial Appendage Closure Device for Embolic Protection in Patients With Atrial Fibrillation (from the PROTECT-AF Trial). Am J Cardiol. 2016 Apr 1;117(7):1127-34. doi: 10.1016/j.amjcard.2016.01.039. Epub 2016 Feb 1.
Results publication: PubMed 28231907Saw J, Tzikas A, Shakir S, Gafoor S, Omran H, Nielsen-Kudsk JE, Kefer J, Aminian A, Berti S, Santoro G, Nietlispach F, Moschovitis A, Cruz-Gonzalez I, Stammen F, Tichelbacker T, Freixa X, Ibrahim R, Schillinger W, Meier B, Sievert H, Gloekler S. Incidence and Clinical Impact of Device-Associated Thrombus and Peri-Device Leak Following Left Atrial Appendage Closure With the Amplatzer Cardiac Plug. JACC Cardiovasc Interv. 2017 Feb 27;10(4):391-399. doi: 10.1016/j.jcin.2016.11.029.
Results publication: PubMed 25604089Tzikas A, Shakir S, Gafoor S, Omran H, Berti S, Santoro G, Kefer J, Landmesser U, Nielsen-Kudsk JE, Cruz-Gonzalez I, Sievert H, Tichelbacker T, Kanagaratnam P, Nietlispach F, Aminian A, Kasch F, Freixa X, Danna P, Rezzaghi M, Vermeersch P, Stock F, Stolcova M, Costa M, Ibrahim R, Schillinger W, Meier B, Park JW. Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. EuroIntervention. 2016 Feb;11(10):1170-9. doi: 10.4244/EIJY15M01_06.
Results publication: PubMed 28145040Lempereur M, Aminian A, Freixa X, Gafoor S, Kefer J, Tzikas A, Legrand V, Saw J. Device-associated thrombus formation after left atrial appendage occlusion: A systematic review of events reported with the Watchman, the Amplatzer Cardiac Plug and the Amulet. Catheter Cardiovasc Interv. 2017 Nov 1;90(5):E111-E121. doi: 10.1002/ccd.26903. Epub 2017 Feb 1.
Results publication: PubMed 29622159Fauchier L, Cinaud A, Brigadeau F, Lepillier A, Pierre B, Abbey S, Fatemi M, Franceschi F, Guedeney P, Jacon P, Paziaud O, Venier S, Deharo JC, Gras D, Klug D, Mansourati J, Montalescot G, Piot O, Defaye P. Device-Related Thrombosis After Percutaneous Left Atrial Appendage Occlusion for Atrial Fibrillation. J Am Coll Cardiol. 2018 Apr 10;71(14):1528-1536. doi: 10.1016/j.jacc.2018.01.076.
Results publication: PubMed 27931603O'Hara C, O'Hara GE, Jacques F, Champagne J, Lemyre M, Charbonneau L, O'Connor K, Bernier M, Beaudoin J, Rodes-Cabau J, Paradis JM. Run With the Hare and Hunt With the Hounds: Watchman Device Surgical Resection in the Setting of Recurrent Device Related Thrombi in a Patient With Bleeding Diathesis. JACC Cardiovasc Interv. 2016 Dec 12;9(23):e223-e225. doi: 10.1016/j.jcin.2016.09.041. No abstract available.
Results publication: PubMed 27765196Rodriguez-Gabella T, Nombela-Franco L, Regueiro A, Jimenez-Quevedo P, Champagne J, O'Hara G, Bernier M, Macaya C, Rodes-Cabau J. Single Antiplatelet Therapy Following Left Atrial Appendage Closure in Patients With Contraindication to Anticoagulation. J Am Coll Cardiol. 2016 Oct 25;68(17):1920-1921. doi: 10.1016/j.jacc.2016.08.016. No abstract available.
Results publication: PubMed 28065447Jalal Z, Dinet ML, Combes N, Pillois X, Renou P, Sibon I, Iriart X, Thambo JB. Percutaneous left atrial appendage closure followed by single antiplatelet therapy: Short- and mid-term outcomes. Arch Cardiovasc Dis. 2017 Apr;110(4):242-249. doi: 10.1016/j.acvd.2016.09.006. Epub 2017 Jan 3.
Results publication: PubMed 28495432Rodes-Cabau J, O'Hara G, Paradis JM, Bernier M, Rodriguez-Gabella T, Regueiro A, O'Connor K, Beaudoin J, Puri R, Cote M, Champagne J. Changes in Coagulation and Platelet Activation Markers Following Transcatheter Left Atrial Appendage Closure. Am J Cardiol. 2017 Jul 1;120(1):87-91. doi: 10.1016/j.amjcard.2017.03.253. Epub 2017 Apr 12.
Results publication: PubMed 20723861Schwartz RS, Holmes DR, Van Tassel RA, Hauser R, Henry TD, Mooney M, Matthews R, Doshi S, Jones RM, Virmani R. Left atrial appendage obliteration: mechanisms of healing and intracardiac integration. JACC Cardiovasc Interv. 2010 Aug;3(8):870-7. doi: 10.1016/j.jcin.2010.04.017.
Results publication: PubMed 20665856Bass JL. Transcatheter occlusion of the left atrial appendage--experimental testing of a new Amplatzer device. Catheter Cardiovasc Interv. 2010 Aug 1;76(2):181-5. doi: 10.1002/ccd.22536.
Individual participant dataSharing planned: Undecided

Related trials for Left Atrial Appendage Closure

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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 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: under way, not looking for participants, as of the sponsor's last update on 27 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device thrombosis (efficacy outcome) (time frame: 60 days after LAAC). The study lists 2 primary outcomes in all. 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 NCT03568890, which also lists 17 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 27 Mar 2026.