Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-03 @ 2:19 PM
Study NCT ID:
NCT03446794
Status:
COMPLETED
Last Update Posted:
2022-06-24
First Post:
2018-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Left Atrial Appendage Occlusion With WATCHMAN® Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis
Sponsor:
Organization:
Raw JSON
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Clinical characteristics associated to atrial fibrillation in chronic hemodialysis patients. Clin Nephrol. 2000 Sep;54(3):234-9.'}, {'pmid': '11099992', 'type': 'RESULT', 'citation': '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': '20054291', 'type': 'RESULT', 'citation': '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': '21233416', 'type': 'RESULT', 'citation': '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': '25001152', 'type': 'RESULT', 'citation': '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': '12846756', 'type': 'RESULT', 'citation': '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': '23114904', 'type': 'RESULT', 'citation': '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': '854139', 'type': 'RESULT', 'citation': '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': '18003768', 'type': 'RESULT', 'citation': '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': '17720522', 'type': 'RESULT', 'citation': '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': '23114898', 'type': 'RESULT', 'citation': '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': '28038729', 'type': 'RESULT', 'citation': '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': '25500231', 'type': 'RESULT', 'citation': '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': '7740570', 'type': 'RESULT', 'citation': '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': '7776995', 'type': 'RESULT', 'citation': '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': '9565007', 'type': 'RESULT', 'citation': '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': '21694919', 'type': 'RESULT', 'citation': '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': '19713308', 'type': 'RESULT', 'citation': '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': '24452752', 'type': 'RESULT', 'citation': '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': '25352571', 'type': 'RESULT', 'citation': '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': '22894575', 'type': 'RESULT', 'citation': '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': '25324574', 'type': 'RESULT', 'citation': "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': '24685669', 'type': 'RESULT', 'citation': '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': '26088300', 'type': 'RESULT', 'citation': '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': '23325525', 'type': 'RESULT', 'citation': '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': '26822918', 'type': 'RESULT', 'citation': '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': '26820363', 'type': 'RESULT', 'citation': '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': '25172844', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\> 18 years.\n* Stage V chronic kidney disease (GFR \\<15 ml / min) in hemodialysis at the time of left atrial appendage closure.\n* History of atrial or valvular fibrillation (paroxysmal, persistent, permanent).\n* Less moderate embolic risk (CHA2DS2-VASc ≥2) or active oral anticoagulant therapy due to atrial fibrillation.\n* High associated hemorrhagic risk (HASBLED ≥ 3) or a history of major bleeding (BARC\\> 2).\n* The patient has been informed of the characteristics of the study and has provided written informed consent.\n\nExclusion Criteria:\n\n* Life expectancy \\< 2 years.\n* Indication for OA different from NVAF.\n* Severe pericardial effusion.\n* Previous percutaneous closure of atrial septal defect.\n* Intracardiac thrombus.\n* Severe hepatic dysfunction with spontaneous INR (International Normalized Ratio) \\> 1.5.\n* The patient refuses to participate in the study.'}, 'identificationModule': {'nctId': 'NCT03446794', 'acronym': 'WATCH-HD', 'briefTitle': 'Left Atrial Appendage Occlusion With WATCHMAN® Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Fundación EPIC'}, 'officialTitle': 'Registry of Left Atrial Appendage Occlusion With WATCHMAN® Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis', 'orgStudyIdInfo': {'id': 'WATCH-HD EPIC-06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with NVAF and ESCKD on HD', 'interventionNames': ['Other: Non Intervention']}], 'interventions': [{'name': 'Non Intervention', 'type': 'OTHER', 'otherNames': ['Safety and efficacy'], 'description': 'To assess the procedural safety and efficacy on stroke and bleeding prevention of LAAC in patients with NVAF and ESCKD on HD', 'armGroupLabels': ['patients with NVAF and ESCKD on HD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03293', 'city': 'Torrevieja', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital de Vinalopó', 'geoPoint': {'lat': 37.97872, 'lon': -0.68222}}, {'zip': '28922', 'city': 'Alcorcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundación Alcorcón', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'zip': '29603', 'city': 'Marbella', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Costa del Sol', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'zip': '03010', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Santa Creu y Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '11009', 'city': 'Cadiz', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta del Mar', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'zip': '21005', 'city': 'Huelva', 'country': 'Spain', 'facility': 'Hospital Juan Ramón Jiménez Huelva', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'zip': '23007', 'city': 'Jaén', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Jaén', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '35010', 'city': 'Las Palmas de Gran Canaria', 'country': 'Spain', 'facility': 'Hospital Universitario de Gran Canaria Dr. Negrín', 'geoPoint': {'lat': 28.10178, 'lon': -15.41573}}, {'zip': '24071', 'city': 'León', 'country': 'Spain', 'facility': 'Hospital Universitario de León', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28222', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '30120', 'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '33011', 'city': 'Oviedo', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'Clínica Universitaria de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario Santiago de Compostela', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación EPIC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}