- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02533752
Canadian WATCHMAN Registry (WATCHMAN)
8. august 2018 opdateret af: Jacqueline Saw, MD, Cardiology Research UBC
Canadian WATCHMAN Registry is a multicentre (8 Centres) Canadian prospective, non-randomized, registry to enrol 100 consecutive patients undergoing LAA closure with the WATCHAN device to study the safety and effectiveness of the WATCHMAN device
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
Atrial fibrillation (AF) is the most common cardiac arrhythmia with current prevalence estimated at 1.5-2% of the general population.
AF is a major cause of stroke, responsible for 15% of all strokes and 30% of strokes in patients age >80.
Stroke is the leading cause of long-term disability and is the 4th leading cause of death in the US.
Anticoagulation is the mainstay therapy for preventing strokes in AF with a 64% relative stroke reduction and 26% relative mortality benefit with warfarin therapy.
Warfarin or newer anticoagulation treatments (NOAC) have been associated with increased risk of major bleeding and therefore a significant proportion (30-50%) of eligible patients do not receive therapy due to perceived risk of bleeding.
The need for newer therapy is therefore required and percutaneous left atrial appendage closure (LAAC) devices have been investigated for patients with high risk of stroke and contra-indication to long term oral anticoagulation therapy.
The WATCHMAN device is one of the leading LAA closure devices and with the most world-wide clinical experience.
The investigators are running a multicentre (8 Centres) Canadian prospective, non-randomized, registry to enrol 100 consecutive patients undergoing LAA closure with the WATCHAN device to study the safety and effectiveness of the WATCHMAN device.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada
- Rekruttering
- Vancouver General Hospital
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Kontakt:
- Andrew Sytarovoytov, MD
- Telefonnummer: 604 875 5079
- E-mail: a.starovoytov@ubc.ca
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Underforsker:
- Jacqueline Saw, MD
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients undergoing WATCHMAN device Implantation
Beskrivelse
Inclusion Criteria:
- Age ≥18 years, and
- CHADS2 ≥1 and/or CHADS-VASc ≥2, and
- Prior major bleeding (intracranial, gastrointestinal bleeding, intraocular, respiratory, genitourinary, retroperitoneal, pericardial, anemia requiring transfusions, etc.), or contraindications to long-term OAC (HASBLED ≥3, high fall risk, cerebral aneurysm, blood dyscrasias, aortic dissection, etc.), or failure of OAC (stroke/TIA while on OAC)
Exclusion Criteria:
- Presence of LAA thrombus
- Severe untreated mitral stenosis (no prior valve replacement)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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Main Group
This an observational registry - there is only one group
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Major Adverse Events
Tidsramme: From up to 24 Months from procedure
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Composite: Cardiovascular death (or unexplained death), device embolization, stroke, systemic embolism, myocardial infarction, cardiac tamponade, major bleeding, and the need for cardiovascular surgery
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From up to 24 Months from procedure
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Long-term Events
Tidsramme: From hospital discharge to 24 Months
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Composite: Overall mortality, cardiovascular mortality, ischemic and hemorrhagic stroke, systemic embolization, late device embolization (beyond hospitalization)
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From hospital discharge to 24 Months
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Procedural Technical Success
Tidsramme: Procedural (up to the end of procedure)
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Procedure duration and complications
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Procedural (up to the end of procedure)
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Procedural complications
Tidsramme: Procedural (up to hospital discharge)
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Stroke (ischemic and hemorrhagic), air embolism, pericardial effusion (minor - not requiring intervention; serious - requiring percutaneous or surgical drainage), cardiac perforation, device embolization, major or life-threatening/disabling bleeding
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Procedural (up to hospital discharge)
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Andre resultatmål
Resultatmål |
Tidsramme |
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Ability to switch to single antiplatelet therapy
Tidsramme: up to 3 Months from procedure
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up to 3 Months from procedure
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Prevalence and severity of residual leak
Tidsramme: up to 3 Months from procedure
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up to 3 Months from procedure
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Prevalence of device thrombus
Tidsramme: up to 3 Months from procedure
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up to 3 Months from procedure
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jacqueline Saw, MD, University of British Columbia
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available. Erratum In: Circulation. 2010 Jul 6;122(1):e10. Kissela, Bret [corrected to Kissela, Brett].
- Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol. 2013 Oct 15;112(8):1142-7. doi: 10.1016/j.amjcard.2013.05.063. Epub 2013 Jul 4.
- Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation: a major contributor to stroke in the elderly. The Framingham Study. Arch Intern Med. 1987 Sep;147(9):1561-4.
- Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.
- Zabalgoitia M, Halperin JL, Pearce LA, Blackshear JL, Asinger RW, Hart RG. Transesophageal echocardiographic correlates of clinical risk of thromboembolism in nonvalvular atrial fibrillation. Stroke Prevention in Atrial Fibrillation III Investigators. J Am Coll Cardiol. 1998 Jun;31(7):1622-6. doi: 10.1016/s0735-1097(98)00146-6.
- Hughes M, Lip GY; Guideline Development Group, National Clinical Guideline for Management of Atrial Fibrillation in Primary and Secondary Care, National Institute for Health and Clinical Excellence. Stroke and thromboembolism in atrial fibrillation: a systematic review of stroke risk factors, risk stratification schema and cost effectiveness data. Thromb Haemost. 2008 Feb;99(2):295-304. doi: 10.1160/TH07-08-0508.
- Fagan SM, Chan KL. Transesophageal echocardiography risk factors for stroke in nonvalvular atrial fibrillation. Echocardiography. 2000 May;17(4):365-72. doi: 10.1111/j.1540-8175.2000.tb01152.x.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2014
Primær færdiggørelse (Forventet)
1. september 2020
Studieafslutning (Forventet)
1. september 2020
Datoer for studieregistrering
Først indsendt
24. marts 2015
Først indsendt, der opfyldte QC-kriterier
24. august 2015
Først opslået (Skøn)
27. august 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. august 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. august 2018
Sidst verificeret
1. august 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H14-01816
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Atrieflimren
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Pusan National University HospitalIkke rekrutterer endnuHjerteimplanterbar elektronisk enhed | Atrial High Rate EpisodeKorea, Republikken
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Henry Ford Health SystemTrukket tilbage
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Academisch Medisch Centrum - Universiteit van Amsterdam...Tilmelding efter invitationKortkoblet idiopatisk ventrikulær fibrillationHolland
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Assiut UniversityTrukket tilbageASD2 (Secundum atrial septal defekt)
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Nobles Medical Technologies II IncTilmelding efter invitationForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater, Italien
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HeartStitch.ComUkendtForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater
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Occlutech International ABAfsluttetSecundum atrial septal defekter
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Institute of Cardiology, Warsaw, PolandUkendtOstium Secundum AtrieseptumdefektPolen