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- Ensaio Clínico NCT02081807
Sequential Expansion of Comparative Effectiveness of Anticoagulants
10 de setembro de 2019 atualizado por: Boehringer Ingelheim
Sequential Expansion of Comparative Effectiveness of Oral Anticoagulants: A Cohort Study
This cohort study is the sequential expansion of the comparative effectiveness study of oral anticoagulants and plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database to quantify associations between anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with non-valvular atrial fibrillation at risk for stroke.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Observacional
Inscrição (Real)
221228
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02120
- Brigham and Women's Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Patients 18 years of age and older with non-valvular AF initiating oral anticoagulation therapy
Descrição
Inclusion criteria:
- A recorded diagnosis of atrial fibrillation.
- Initiation of anticoagulant medication (dabigatran (or other new oral anticoagulants as they become available) or warfarin).
- At least 18 years of age on the date of anticoagulant initiation.
- Congestive Heart Failure, Hypertension, Age > 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) score at least 1
Exclusion criteria:
- Patients with missing or ambiguous age or sex information.
- Patients with evidence of valvular disease.
- Patients with less than 12 months enrolment preceding the date of anticoagulant initiation
- Patients with a dispensing of any oral anticoagulant during the 12 months preceding the date of anticoagulant initiation
- Patients with a nursing home stay during the 12 months preceding the date of anticoagulant initiation
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Dabigatrana
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Varfarina
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Stroke (Hemorrhagic, Ischemic, or Stroke of Uncertain Classification)
Prazo: From October 2010 to September 2015 (the study period)
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The rate of overall stroke (hemorrhagic, ischemic or stroke of uncertain classification ) in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
The outcome definition includes following: As primary International Classification of Diseases, Ninth Revision (ICD-9) discharge diagnosis (Dx): 431.x
Intracerebral hemorrhage (ICH), 433.x1
Occlusion and stenosis of precerebral arteries with cerebral infarction, 434.x1
Occlusion and stenosis of cerebral arteries with cerebral infarction, 436.x
Acute, but ill-defined cerebrovascular events.
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From October 2010 to September 2015 (the study period)
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Major Bleeding
Prazo: From October 2010 to September 2015 (the study period)
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The rate of major bleeding (Major intracranial bleeding and major extracranial bleed ) in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
For outcome definitions please refer the descriptions section of outcome 8 (major intracranial bleeding) and outcome 9 (major extracranial bleeding).
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From October 2010 to September 2015 (the study period)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Stroke or Systemic Embolism
Prazo: From October 2010 to September 2015 (the study period)
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The rate of stroke (hemorrhagic, ischemic or stroke of uncertain classification ) or systemic embolism in patients matched on propensity scores and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
For outcome definitions please refer the descriptions section of outcome 4 (Systemic embolism), outcome 5 (Ischemic stroke), outcome 6 (Hemorrhagic stroke) and outcome 7 (Stroke uncertain classification).
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From October 2010 to September 2015 (the study period)
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Systemic Embolism
Prazo: From October 2010 to September 2015 (the study period)
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The rate of systemic embolism in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
The outcome definition includes following: ICD-9 Diagnoses: 444.x
Arterial embolism.
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From October 2010 to September 2015 (the study period)
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Ischemic Stroke
Prazo: From October 2010 to September 2015 (the study period)
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The rate of ischemic stroke in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 433.x1
Occlusion and stenosis of precerebral arteries with cerebral infarction, ICD-9 Dx 434.x1
Occlusion and stenosis of cerebral arteries with cerebral infarction
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From October 2010 to September 2015 (the study period)
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Hemorrhagic Stroke
Prazo: From October 2010 to September 2015 (the study period)
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The rate of hemorrhagic in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 431.x
Intracerebral hemorrhage (ICH)
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From October 2010 to September 2015 (the study period)
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Stroke Uncertain Classification
Prazo: From October 2010 to September 2015 (the study period)
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The rate of stroke uncertain classification in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): ICD-9 Dx code 436.x (acute, but ill-defined cerebrovascular disease).
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From October 2010 to September 2015 (the study period)
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Major Intracranial Bleeding
Prazo: From October 2010 to September 2015 (the study period)
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The rate of major intracranial bleeding in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
The outcome definition includes following: ICD-9 diagnosis: 430.x
Subarachnoid hemorrhage (SAH), 431.x
Intracerebral hemorrhage (ICH), 432.x other and unspecified intracranial hemorrhage including 432.1x - subdural hemorrhage
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From October 2010 to September 2015 (the study period)
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Major Extra-cranial Bleeding
Prazo: From October 2010 to September 2015 (the study period)
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The rate of major extracranial bleeding (Major upper GI bleed, major lower and unspecified GI bleed, major urogenital bleed, major other bleed) in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding), outcome 12 (Major lower gastrointestinal bleeding), outcome 13 (Major urogenital bleeding) and outcome 14 (Other major bleeding).
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From October 2010 to September 2015 (the study period)
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Major Gastrointestinal (GI) Bleeding
Prazo: From October 2010 to September 2015 (the study period)
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The rate of major gastrointestinal (GI) bleeding (Major upper GI bleeding, major lower/unspecified GI bleeding) in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding) and outcome 12 (Major lower gastrointestinal bleeding).
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From October 2010 to September 2015 (the study period)
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Major Upper Gastrointestinal Bleeding
Prazo: From October 2010 to September 2015 (the study period)
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The rate of Major upper gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
The outcome definition includes following: ICD-9 diagnoses: 531.0x, 531.2x, 531.4x, 531.6x, 532.0x, 532.2x, 532.4x, 532.6x, 533.0x, 533.2x, 533.4x, 533.6x, 534.0x, 534.2x, 534.4x, 534.6x, 578.0 OR ICD-9 procedure code 44.43 (endoscopic control of gastric or duodenal bleeding) OR Current Procedural Terminology (CPT) code 43255 (upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method).
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From October 2010 to September 2015 (the study period)
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Major Lower Gastrointestinal Bleeding
Prazo: From October 2010 to September 2015 (the study period)
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The rate of lower gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
The outcome definition includes following: Lower GI/unspecified GI site bleeds :Diverticulosis of small intestine with hemorrhage: 562.02,
Diverticulitis of small intestine with hemorrhage: 562.03,
Diverticulosis of colon with hemorrhage: 562.12,
Diverticulitis of colon with hemorrhage: 562.13,
Hemorrhage of rectum and anus: 569.3x,
Angiodysplasia of intestine with hemorrhage: 569.85,
Blood in stool: 578.1x,
Hemorrhage of GI tract, unspecified: 578.9
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From October 2010 to September 2015 (the study period)
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Major Urogenital Bleeding
Prazo: From October 2010 to September 2015 (the study period)
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The rate of major urogenital bleeding in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
The outcome definition includes following: ICD-9 diagnoses: Hematuria: ICD-9 Dx: 599.7,
Excessive/frequent menstruation: ICD-9 Dx 626.2x and secondary diagnosis indicating acute bleeding: anemia (280.0,
285.1, 285.9).
Across databases, only one event for dabigatran versus no event among warfarin initiators observed.
Across database, four events for rivaroxaban versus no event among warfarin initiators observed.
Across database, no events for apixaban and warfarin observed.
Therefore HR estimate is not possible.
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From October 2010 to September 2015 (the study period)
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Other Major Bleeding
Prazo: From October 2010 to September 2015 (the study period)
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The rate of Other major bleeding in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
The outcome definition includes following: Other major bleeds: Hemathrosis: 719.1x,
Hemopericardium: 423.0x,
Hemoptysis: 786.3x,
Epistaxis: 784.7x,
Hemorrhage not specified 459.0x,
Acute posthemorrhagic anemia 285.1x
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From October 2010 to September 2015 (the study period)
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Transient Ischemic Attack (TIA)
Prazo: From October 2010 to September 2015 (the study period)
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The rate of Transient Ischemic Attack (TIA) in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
The outcome definition includes following: ICD-9 Dx code 435.xx (transient cerebral ischemia) as the principal (primary) discharge diagnosis
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From October 2010 to September 2015 (the study period)
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Myocardial Infarction (MI)
Prazo: From October 2010 to September 2015 (the study period)
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The rate of Myocardial infarction (MI) in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
The outcome definition includes following: ICD-9 Dx 410.X (acute myocardial infarction) excluding 410.x2 (subsequent episode of care), as the principal (primary) or the next (secondary) diagnosis AND a length of stay (LOS) between 3-180 days, or death if LOS is < 3 days
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From October 2010 to September 2015 (the study period)
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Venous Thromboembolism (VTE)
Prazo: From October 2010 to September 2015 (the study period)
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The rate of Venous Thromboembolism (VTE) in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
For outcome definitions please refer the descriptions section of outcome 18 (Deep vein thrombosis (DVT)) and outcome 19 (Pulmonary Embolism (PE)).
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From October 2010 to September 2015 (the study period)
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Deep Vein Thrombosis (DVT)
Prazo: From October 2010 to September 2015 (the study period)
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The rate of DVT in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
The outcome definition includes following: Validated algorithm: ICD-9 451.1x,
ICD-9 451.2x,ICD-9 451.81,
ICD-9 451.9x,
ICD-9 453.1x,
ICD-9 453.2x,
ICD-9 453.8x,
ICD-9 453.9x ; Not in the validated algorithm but will be included following Mini-Sentinel recommendation for VTE outcome: ICD-9 453.40 (Venous embolism and thrombosis of unspecified deep vessels of lower extremity (includes DVT), ICD-9 453.41 (Venous embolism and thrombosis of deep vessels of proximal lower extremity (includes femoral, iliac, popliteal, thigh, and upper leg), ICD-9 453.42 (Venous embolism and thrombosis of deep vessels of distal lower extremity (includes calf, lower leg, peroneal, and tibia), ICD-9 453.0 (Hepatic vein thrombosis)
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From October 2010 to September 2015 (the study period)
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Pulmonary Embolism (PE)
Prazo: From October 2010 to September 2015 (the study period)
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The rate of Pulmonary Embolism (PE) in patients who are matched on propensity score and calendar quarter of initiation.
Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.
The outcome definition includes following: ICD-9 415.1x (pulmonary embolism and infarction)
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From October 2010 to September 2015 (the study period)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
7 de março de 2014
Conclusão Primária (Real)
1 de novembro de 2017
Conclusão do estudo (Real)
1 de novembro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
6 de março de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de março de 2014
Primeira postagem (Estimativa)
7 de março de 2014
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de outubro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de setembro de 2019
Última verificação
1 de setembro de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1160.207
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Fibrilação atrial
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Ablacon, Inc.RecrutamentoFibrilação atrial | Arritmias Cardíacas | Arritmia | Flutter Atrial | Fibrilação Atrial, Persistente | Taquicardia Atrial | Arritmia Atrial | Fibrilação Atrial Paroxística | Fibrilação Atrial, Paroxística ou PersistenteEstados Unidos, Bélgica, Holanda, Tcheca
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Vivek ReddyInscrevendo-se por conviteFibrilação e Flutter Atrial | Flutter Atrial Típico | Fibrilação Atrial, Paroxística ou PersistenteEstados Unidos
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Angelo BivianoConcluído
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Adagio MedicalRecrutamentoFibrilação atrial | Flutter Atrial | Fibrilação Atrial Paroxística | Fibrilação Atrial PersistenteHolanda, Alemanha, Bélgica
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Johannes Gutenberg University MainzBoehringer Ingelheim; Atrial Fibrillation NetworkRescindidoFibrilação Atrial ou Flutter Atrial | Trombose do Apêndice Atrial EsquerdoAlemanha
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Fundació Institut de Recerca de l'Hospital de la...RecrutamentoArritmia Atrial | Fibrilação e Flutter Atrial | Fibrilação Atrial RecorrenteEspanha
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Abbott Medical DevicesRecrutamentoFibrilação atrial | Fibrilação Atrial Paroxística | Fibrilação Atrial Persistente | Arritmia AtrialEstados Unidos, Espanha, Bélgica, Austrália, Alemanha, Holanda, França, Áustria, Canadá, Tcheca, Itália, Reino Unido
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St. George's Hospital, LondonRecrutamentoFibrilação atrial | Fibrilação Atrial, Persistente | Fibrilação Atrial Persistente | Arritmia AtrialReino Unido
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R-PharmFSBI "National Medical Research Center of Cardiology named after academician...ConcluídoFlutter Atrial | Fibrilação Atrial Paroxística | Fibrilação Atrial PersistenteFederação Russa
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Barts & The London NHS TrustAtriCure, Inc.Ainda não está recrutandoFibrilação Atrial, Persistente | Fibrilação Atrial Persistente | Arritmia Atrial | Átrio; FibrilaçãoReino Unido