NCT03446794

Brief Summary

Atrial fibrillation (AF) is more common in patients with renal disease compared to the general population an risk increase to as much as 10 times in patients on hemodialysis (HD). Stroke is an important cause of morbidity, mortality and suffering for patients with end-stage chronic kidney disease (ESCKD) on hemodialysis.The risk of bleeding in these patients can be roughly 5-fold higher that without it. Current guidelines recommend the use of oral anticoagulants (AO) to prevent stroke or systemic thromboembolism in high-risk patients with AF. Left atrial appendage occlusion (LAAO) reduces the risk of bleeding while allows thromboembolic stroke prevention. The aim of the study is to assess the procedural safety on stroke and bleeding prevention of LAAC in patients with non-valvular atrial fibrillation (NVAF) and ESCKD on HD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

March 14, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2022

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

3.8 years

First QC Date

February 19, 2018

Last Update Submit

June 19, 2022

Conditions

Atrial FibrillationHeart DiseasesRenal DiseaseBleedingArrhythmias, CardiacCardiovascular Diseases

Keywords

Left Atrial Appendage ClosureWatchman device

Outcome Measures

Primary Outcomes (1)

  • Composite of all-cause mortality, stroke and bleeding

    Composite: Stroke or Transient Ischemic Attack (TIA), Systemic embolism, Major bleeding event (BARC ≥ 2). Systemic embolism, Major bleeding event (BARC ≥ 2)

    24 month

Secondary Outcomes (3)

  • Periprocedural major adverse events

    2 days

  • Echocardiographic adverse events during follow up

    24 month

  • Echocardiographic adverse events during follow up

    24 month

Study Arms (1)

patients with NVAF and ESCKD on HD

Other: Non Intervention

Interventions

Non InterventionOTHER

To assess the procedural safety and efficacy on stroke and bleeding prevention of LAAC in patients with NVAF and ESCKD on HD

Also known as: Safety and efficacy
patients with NVAF and ESCKD on HD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis .

You may qualify if:

  • Age\> 18 years.
  • Stage V chronic kidney disease (GFR \<15 ml / min) in hemodialysis at the time of left atrial appendage closure.
  • History of atrial or valvular fibrillation (paroxysmal, persistent, permanent).
  • Less moderate embolic risk (CHA2DS2-VASc ≥2) or active oral anticoagulant therapy due to atrial fibrillation.
  • High associated hemorrhagic risk (HASBLED ≥ 3) or a history of major bleeding (BARC\> 2).
  • The patient has been informed of the characteristics of the study and has provided written informed consent.

You may not qualify if:

  • Life expectancy \< 2 years.
  • Indication for OA different from NVAF.
  • Severe pericardial effusion.
  • Previous percutaneous closure of atrial septal defect.
  • Intracardiac thrombus.
  • Severe hepatic dysfunction with spontaneous INR (International Normalized Ratio) \> 1.5.
  • The patient refuses to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Hospital de Vinalopó

Torrevieja, Alicante, 03293, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Hospital Costa del Sol

Marbella, Málaga, 29603, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Santa Creu y Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital Juan Ramón Jiménez Huelva

Huelva, 21005, Spain

Location

Complejo Hospitalario de Jaén

Jaén, 23007, Spain

Location

Hospital Universitario de Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, 35010, Spain

Location

Hospital Universitario de León

León, 24071, Spain

Location

Hospital Clínico Universitario San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, 28222, Spain

Location

Hospital Universitario Virgen de Arrixaca

Murcia, 30120, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

Location

Clínica Universitaria de Navarra

Pamplona, 31008, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Clínico Universitario Santiago de Compostela

Santiago de Compostela, 15706, Spain

Location

Hospital Universitario Virgen de la Macarena

Seville, 41009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (28)

  • Fabbian F, Catalano C, Lambertini D, Tarroni G, Bordin V, Squerzanti R, Gilli P, Di Landro D, Cavagna R. Clinical characteristics associated to atrial fibrillation in chronic hemodialysis patients. Clin Nephrol. 2000 Sep;54(3):234-9.

    PMID: 11020022RESULT

  • Vazquez E, Sanchez-Perales C, Borrego F, Garcia-Cortes MJ, Lozano C, Guzman M, Gil JM, Borrego MJ, Perez V. Influence of atrial fibrillation on the morbido-mortality of patients on hemodialysis. Am Heart J. 2000 Dec;140(6):886-90. doi: 10.1067/mhj.2000.111111.

    PMID: 11099992RESULT

  • Wizemann V, Tong L, Satayathum S, Disney A, Akiba T, Fissell RB, Kerr PG, Young EW, Robinson BM. Atrial fibrillation in hemodialysis patients: clinical features and associations with anticoagulant therapy. Kidney Int. 2010 Jun;77(12):1098-106. doi: 10.1038/ki.2009.477. Epub 2010 Jan 6.

    PMID: 20054291RESULT

  • Winkelmayer WC, Patrick AR, Liu J, Brookhart MA, Setoguchi S. The increasing prevalence of atrial fibrillation among hemodialysis patients. J Am Soc Nephrol. 2011 Feb;22(2):349-57. doi: 10.1681/ASN.2010050459. Epub 2011 Jan 13.

    PMID: 21233416RESULT

  • Providencia R, Marijon E, Boveda S, Barra S, Narayanan K, Le Heuzey JY, Gersh BJ, Goncalves L. Meta-analysis of the influence of chronic kidney disease on the risk of thromboembolism among patients with nonvalvular atrial fibrillation. Am J Cardiol. 2014 Aug 15;114(4):646-53. doi: 10.1016/j.amjcard.2014.05.048. Epub 2014 Jun 6.

    PMID: 25001152RESULT

  • Seliger SL, Gillen DL, Longstreth WT Jr, Kestenbaum B, Stehman-Breen CO. Elevated risk of stroke among patients with end-stage renal disease. Kidney Int. 2003 Aug;64(2):603-9. doi: 10.1046/j.1523-1755.2003.00101.x.

    PMID: 12846756RESULT

  • Zimmerman D, Sood MM, Rigatto C, Holden RM, Hiremath S, Clase CM. Systematic review and meta-analysis of incidence, prevalence and outcomes of atrial fibrillation in patients on dialysis. Nephrol Dial Transplant. 2012 Oct;27(10):3816-22. doi: 10.1093/ndt/gfs416.

    PMID: 23114904RESULT

  • Biggers JA, Remmers AR Jr, Glassford DM, Sarles HE, Lindley JD, Fish JC. The risk of anticoagulation in hemodialysis patients. Nephron. 1977;18(2):109-13. doi: 10.1159/000180784.

    PMID: 854139RESULT

  • Holden RM, Harman GJ, Wang M, Holland D, Day AG. Major bleeding in hemodialysis patients. Clin J Am Soc Nephrol. 2008 Jan;3(1):105-10. doi: 10.2215/CJN.01810407. Epub 2007 Nov 14.

    PMID: 18003768RESULT

  • Elliott MJ, Zimmerman D, Holden RM. Warfarin anticoagulation in hemodialysis patients: a systematic review of bleeding rates. Am J Kidney Dis. 2007 Sep;50(3):433-40. doi: 10.1053/j.ajkd.2007.06.017.

    PMID: 17720522RESULT

  • Clase CM, Holden RM, Sood MM, Rigatto C, Moist LM, Thomson BK, Mann JF, Zimmerman DL. Should patients with advanced chronic kidney disease and atrial fibrillation receive chronic anticoagulation? Nephrol Dial Transplant. 2012 Oct;27(10):3719-24. doi: 10.1093/ndt/gfs346.

    PMID: 23114898RESULT

  • Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Alexandru Popescu B, Schotten U, Van Putte B, Vardas P. 2016 ESC Guidelines for the Management of Atrial Fibrillation Developed in Collaboration With EACTS. Rev Esp Cardiol (Engl Ed). 2017 Jan;70(1):50. doi: 10.1016/j.rec.2016.11.033. No abstract available. English, Spanish.

    PMID: 28038729RESULT

  • Bonde AN, Lip GY, Kamper AL, Hansen PR, Lamberts M, Hommel K, Hansen ML, Gislason GH, Torp-Pedersen C, Olesen JB. Net clinical benefit of antithrombotic therapy in patients with atrial fibrillation and chronic kidney disease: a nationwide observational cohort study. J Am Coll Cardiol. 2014 Dec 16;64(23):2471-82. doi: 10.1016/j.jacc.2014.09.051.

    PMID: 25500231RESULT

  • van Latum JC, Koudstaal PJ, Venables GS, van Gijn J, Kappelle LJ, Algra A. Predictors of major vascular events in patients with a transient ischemic attack or minor ischemic stroke and with nonrheumatic atrial fibrillation. European Atrial Fibrillation Trial (EAFT) Study Group. Stroke. 1995 May;26(5):801-6. doi: 10.1161/01.str.26.5.801.

    PMID: 7740570RESULT

  • European Atrial Fibrillation Trial Study Group. Optimal oral anticoagulant therapy in patients with nonrheumatic atrial fibrillation and recent cerebral ischemia. N Engl J Med. 1995 Jul 6;333(1):5-10. doi: 10.1056/NEJM199507063330102.

    PMID: 7776995RESULT

  • Patients with nonvalvular atrial fibrillation at low risk of stroke during treatment with aspirin: Stroke Prevention in Atrial Fibrillation III Study. The SPAF III Writing Committee for the Stroke Prevention in Atrial Fibrillation Investigators. JAMA. 1998 Apr 22-29;279(16):1273-7.

    PMID: 9565007RESULT

  • Lai HM, Aronow WS, Kalen P, Adapa S, Patel K, Goel A, Vinnakota R, Chugh S, Garrick R. Incidence of thromboembolic stroke and of major bleeding in patients with atrial fibrillation and chronic kidney disease treated with and without warfarin. Int J Nephrol Renovasc Dis. 2009;2:33-7. doi: 10.2147/ijnrd.s7781. Epub 2009 Nov 19.

    PMID: 21694919RESULT

  • Chan KE, Lazarus JM, Thadhani R, Hakim RM. Warfarin use associates with increased risk for stroke in hemodialysis patients with atrial fibrillation. J Am Soc Nephrol. 2009 Oct;20(10):2223-33. doi: 10.1681/ASN.2009030319. Epub 2009 Aug 27.

    PMID: 19713308RESULT

  • Shah M, Avgil Tsadok M, Jackevicius CA, Essebag V, Eisenberg MJ, Rahme E, Humphries KH, Tu JV, Behlouli H, Guo H, Pilote L. Warfarin use and the risk for stroke and bleeding in patients with atrial fibrillation undergoing dialysis. Circulation. 2014 Mar 18;129(11):1196-203. doi: 10.1161/CIRCULATIONAHA.113.004777. Epub 2014 Jan 22.

    PMID: 24452752RESULT

  • Genovesi S, Rossi E, Gallieni M, Stella A, Badiali F, Conte F, Pasquali S, Bertoli S, Ondei P, Bonforte G, Pozzi C, Rebora P, Valsecchi MG, Santoro A. Warfarin use, mortality, bleeding and stroke in haemodialysis patients with atrial fibrillation. Nephrol Dial Transplant. 2015 Mar;30(3):491-8. doi: 10.1093/ndt/gfu334. Epub 2014 Oct 28.

    PMID: 25352571RESULT

  • Olesen JB, Lip GY, Kamper AL, Hommel K, Kober L, Lane DA, Lindhardsen J, Gislason GH, Torp-Pedersen C. Stroke and bleeding in atrial fibrillation with chronic kidney disease. N Engl J Med. 2012 Aug 16;367(7):625-35. doi: 10.1056/NEJMoa1105594.

    PMID: 22894575RESULT

  • Tantisattamo E, Han KH, O'Neill WC. Increased vascular calcification in patients receiving warfarin. Arterioscler Thromb Vasc Biol. 2015 Jan;35(1):237-42. doi: 10.1161/ATVBAHA.114.304392. Epub 2014 Oct 16.

    PMID: 25324574RESULT

  • 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; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.

    PMID: 24685669RESULT

  • Holmes DR Jr, Doshi SK, Kar S, Price MJ, Sanchez JM, Sievert H, Valderrabano M, Reddy VY. Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation: A Patient-Level Meta-Analysis. J Am Coll Cardiol. 2015 Jun 23;65(24):2614-2623. doi: 10.1016/j.jacc.2015.04.025.

    PMID: 26088300RESULT

  • Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16.

    PMID: 23325525RESULT

  • Boersma LV, Schmidt B, Betts TR, Sievert H, Tamburino C, Teiger E, Pokushalov E, Kische S, Schmitz T, Stein KM, Bergmann MW; EWOLUTION investigators. Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. Eur Heart J. 2016 Aug;37(31):2465-74. doi: 10.1093/eurheartj/ehv730. Epub 2016 Jan 27.

    PMID: 26822918RESULT

  • Kefer J, Tzikas A, Freixa X, Shakir S, Gafoor S, Nielsen-Kudsk JE, Berti S, Santoro G, Aminian A, Landmesser U, Nietlispach F, Ibrahim R, Danna PL, Benit E, Budts W, Stammen F, De Potter T, Tichelbacker T, Gloekler S, Kanagaratnam P, Costa M, Cruz-Gonzalez I, Sievert H, Schillinger W, Park JW, Meier B, Omran H. Impact of chronic kidney disease on left atrial appendage occlusion for stroke prevention in patients with atrial fibrillation. Int J Cardiol. 2016 Mar 15;207:335-40. doi: 10.1016/j.ijcard.2016.01.003. Epub 2016 Jan 9.

    PMID: 26820363RESULT

  • Meier B, Blaauw Y, Khattab AA, Lewalter T, Sievert H, Tondo C, Glikson M; Document Reviewers. EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion. Europace. 2014 Oct;16(10):1397-416. doi: 10.1093/europace/euu174. Epub 2014 Aug 29. No abstract available.

    PMID: 25172844RESULT

MeSH Terms

Conditions

Atrial FibrillationHeart DiseasesKidney DiseasesHemorrhageArrhythmias, CardiacCardiovascular Diseases

Interventions

Safety

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Accident PreventionAccidentsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2018

First Posted

February 27, 2018

Study Start

March 14, 2018

Primary Completion

January 7, 2022

Study Completion

January 7, 2022

Last Updated

June 24, 2022

Record last verified: 2022-06

Locations

ES(20)