- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02392338
Hybrid Procedure in Patients With Persistent Atrial Fibrillation
Comparison of Success Rate of Totally Thoracoscopic Ablation Versus Hybrid Procedure in Patients With Persistent Atrial Fibrillation
Studieoversigt
Detaljeret beskrivelse
Atrial fibrillation is highly associated with sudden death and stroke, requiring definitive treatment. In Korea, atrial fibrillation is a common disease predicted to affect more than 5% of the population over 65 years of age and more than 10% over 80 years.
Totally thoracoscopic ablation has been adopted and performed successfully on February 2012 at Samsung Medical Center for the first time in Korea. More than 120 operations have been performed up to date.
In Korea, treatment for atrial fibrillation is still dependent on percutaneous RFCA, and life-long medication and anticoagulation is needed when recurrent atrial fibrillation occurs. The investigators expected thoracoscopic ablation to be an alternative to overcome this limitation. Also, thoracoscopic ablation and RFCA are recently being performed simultaneously or stage by stage as a hybrid procedure, and the results are being reported.
In this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram and 24 hour Holter monitoring of thoracoscopic ablation and RFCA performed individually or as a hybrid procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic medication, discontinuation of anticoagulation medication, and echocardiographic findings were also analyzed.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Seoul, Korea, Republikken, 135-710
- Samsung Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Long-lasting persistent atrial fibrillation
- Persistent atrial fibrillation refractory to antiarrhythmic drug therapy
- over 18 years
Exclusion Criteria:
- Valvular heart disease of more than moderate degree
- Unresponsive ischemic cardiomyopathy
- Follow-up of over 1 year was not possible
- Warfarin was unable to be used
- Refusal of informed consent
- Left atrial thrombus
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Thoracoscopic ablation group
Patients who will undergo thoracoscopic ablation only
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Aktiv komparator: Hybrid procedure
Patients who will undergo hybrid procedure (thoracoscopic ablation and eletrophyologic study with or without additional ablation)
|
Eletrophysiologic study via femoral vein approach to confirm pulmonary vein isolation lesion and box lesions in left atrium
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Cardiac related death
Tidsramme: one year
|
medical records review
|
one year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Stroke
Tidsramme: postoperative one year
|
medical records review at 3, 6 and 12 months follow up
|
postoperative one year
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Bleeding
Tidsramme: postoperative one year
|
medical records review at 3, 6 and 12 months follow up
|
postoperative one year
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Embolism
Tidsramme: postoperative one year
|
medical records review at 3, 6 and 12 months follow up
|
postoperative one year
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Recurred atrial arrhythmia
Tidsramme: postoperative one year
|
medical records review at 3, 6 and 12 months follow up
|
postoperative one year
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Young Keun On, MD,PhD, Samsung Medical Center
Publikationer og nyttige links
Generelle publikationer
- Pison L, La Meir M, van Opstal J, Blaauw Y, Maessen J, Crijns HJ. Hybrid thoracoscopic surgical and transvenous catheter ablation of atrial fibrillation. J Am Coll Cardiol. 2012 Jul 3;60(1):54-61. doi: 10.1016/j.jacc.2011.12.055.
- Choi MS, On YK, Jeong DS, Park KM, Park SJ, Kim JS, Carriere KC. Usefulness of Postprocedural Electrophysiological Confirmation Upon Totally Thoracoscopic Ablation in Persistent Atrial Fibrillation. Am J Cardiol. 2020 Apr 1;125(7):1054-1062. doi: 10.1016/j.amjcard.2019.12.046. Epub 2020 Jan 8.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2012-10-090
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Atrieflimren
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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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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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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Henry Ford Health SystemTrukket tilbage
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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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University Hospital, Basel, SwitzerlandUniversity Hospital GreifswaldAfsluttetAtrium; Fibrillering | Arytmi AtrialTyskland, Schweiz
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Occlutech International ABAfsluttetSecundum atrial septal defekter
Kliniske forsøg med Hybrid procedure
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Jessa HospitalRekrutteringKoronararteriesygdomBelgien
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University of Roma La SapienzaIkke rekrutterer endnu
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Lawson Health Research InstituteLondon Health Sciences CentreAfsluttet
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Instituto Nacional de Cancerologia de MexicoInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; Instituto... og andre samarbejdspartnereRekrutteringNeoplasma i brystetMexico
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SynergEyes, Inc.AfsluttetOverfølsomhed | HornhindesygdomForenede Stater
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Örebro University, SwedenAktiv, ikke rekrutterendeKronisk smerte | Følelsesmæssigt problemSverige
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Thomas A. Aller, ODSynergEyes, Inc.Trukket tilbageNærsynethed | Nærsynethed, progressivForenede Stater
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Kuopio University HospitalRekrutteringLivskvalitet | Smerte | TilbagevendenFinland
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Weill Medical College of Cornell UniversityNational Institute of Mental Health (NIMH)Trukket tilbageDepression | Kronisk smerteForenede Stater
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Anglia Ruskin UniversityRoyal Brompton & Harefield NHS Foundation Trust; Aseptika Ltd.; So What?...Aktiv, ikke rekrutterende