ID

37467

Descrição

AV-node Stimulation Clinical Download Study to Reduce Ventricular Rate During AF; ODM derived from: https://clinicaltrials.gov/show/NCT01095952

Link

https://clinicaltrials.gov/show/NCT01095952

Palavras-chave

Versões (1)
  1. 30/07/2019 30/07/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

30 de julho de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Atrial Fibrillation NCT01095952

Inglês

Eligibility Atrial Fibrillation NCT01095952

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a documented history of paroxysmal or persistent af are eligible to be enrolled in the study if one of the following criteria is met:
Descrição

Paroxysmal atrial fibrillation | Persistent atrial fibrillation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2585653
indication for crt implant according to current guidelines (heart failure, nyha iii-iv class, symptomatic despite optimal stable medical therapy, left ventricular (lv) ejection fraction ≤35% and qrs≥120ms); or
Descrição

Indication CRT Device Implantation | Heart failure Symptomatic New York Heart Association Classification | Therapy Optimal Stable | Left ventricular ejection fraction | QRS duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2936377
UMLS CUI [1,3]
C0021107
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C1275491
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C2698651
UMLS CUI [3,3]
C0205360
UMLS CUI [4]
C0428772
UMLS CUI [5]
C0429025
indication for upgrading to crt-d from a single chamber device; or
Descrição

Initial implantation of cardiac single-chamber device | Indication CRT-D

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0189846
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1736558
indication for upgrading to crt-d from a dual chamber device with septal atrial lead or a dislodged atrial lead; or
Descrição

Initial implantation of cardiac dual-chamber device Atrial Lead Septal | Indication CRT-D

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0189848
UMLS CUI [1,2]
C2825198
UMLS CUI [1,3]
C0442004
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1736558
indication for device replacement or surgical revision in patients already implanted with a crt-d device and an atrial lead in the septal position or a dislodged atrial lead; or
Descrição

Indication Replacement of device | Indication Surgical revision | Implantation of CRT-D Atrial Lead Septal

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1446530
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0558347
UMLS CUI [3,1]
C1135480
UMLS CUI [3,2]
C2825198
UMLS CUI [3,3]
C0442004
patients already implanted with a consultatm device and an atrial lead in the septal position, requiring electrical cardioversion.
Descrição

Implantation of CRT-D Atrial Lead Septal | Other Coding | Patient need for Electric Countershock

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1135480
UMLS CUI [1,2]
C2825198
UMLS CUI [1,3]
C0442004
UMLS CUI [2]
C3846158
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0013778
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
if any of the following criteria are met, patient cannot be enrolled in the study:
Descrição

Criteria Fulfill

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
permanent atrial fibrillation;
Descrição

Permanent atrial fibrillation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2586056
patients who are not on anti-coagulant therapy;
Descrição

Anticoagulant therapy Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0150457
UMLS CUI [1,2]
C0332197
advanced av block (ii-iii degree av block);
Descrição

Second degree atrioventricular block Advanced | Complete atrioventricular block Advanced

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0264906
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0151517
UMLS CUI [2,2]
C0205179
patients previously submitted to valvular surgery;
Descrição

Patients Submitted Operation on heart valve

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C0190065
patients previously submitted to av or af ablative procedures;
Descrição

Patients Submitted Ablation of Cardiac Atrioventricular Node | Patients Submitted Catheter ablation for atrial fibrillation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1515023
UMLS CUI [1,3]
C3275044
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1515023
UMLS CUI [2,3]
C2702800
age < 18 years;
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patient not disposed to sign the informed consent;
Descrição

Informed Consent Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
participation in other studies which could potentially conflict with this study;
Descrição

Study Subject Participation Status Interferes with Clinical Trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
Voltar ao início da página

Similar models

Eligibility Atrial Fibrillation NCT01095952

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal atrial fibrillation | Persistent atrial fibrillation
Item
patients with a documented history of paroxysmal or persistent af are eligible to be enrolled in the study if one of the following criteria is met:
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
Indication CRT Device Implantation | Heart failure Symptomatic New York Heart Association Classification | Therapy Optimal Stable | Left ventricular ejection fraction | QRS duration
Item
indication for crt implant according to current guidelines (heart failure, nyha iii-iv class, symptomatic despite optimal stable medical therapy, left ventricular (lv) ejection fraction ≤35% and qrs≥120ms); or
boolean
C3146298 (UMLS CUI [1,1])
C2936377 (UMLS CUI [1,2])
C0021107 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C2698651 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0428772 (UMLS CUI [4])
C0429025 (UMLS CUI [5])
Initial implantation of cardiac single-chamber device | Indication CRT-D
Item
indication for upgrading to crt-d from a single chamber device; or
boolean
C0189846 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C1736558 (UMLS CUI [2,2])
Initial implantation of cardiac dual-chamber device Atrial Lead Septal | Indication CRT-D
Item
indication for upgrading to crt-d from a dual chamber device with septal atrial lead or a dislodged atrial lead; or
boolean
C0189848 (UMLS CUI [1,1])
C2825198 (UMLS CUI [1,2])
C0442004 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C1736558 (UMLS CUI [2,2])
Indication Replacement of device | Indication Surgical revision | Implantation of CRT-D Atrial Lead Septal
Item
indication for device replacement or surgical revision in patients already implanted with a crt-d device and an atrial lead in the septal position or a dislodged atrial lead; or
boolean
C3146298 (UMLS CUI [1,1])
C1446530 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0558347 (UMLS CUI [2,2])
C1135480 (UMLS CUI [3,1])
C2825198 (UMLS CUI [3,2])
C0442004 (UMLS CUI [3,3])
Implantation of CRT-D Atrial Lead Septal | Other Coding | Patient need for Electric Countershock
Item
patients already implanted with a consultatm device and an atrial lead in the septal position, requiring electrical cardioversion.
boolean
C1135480 (UMLS CUI [1,1])
C2825198 (UMLS CUI [1,2])
C0442004 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0013778 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
if any of the following criteria are met, patient cannot be enrolled in the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Permanent atrial fibrillation
Item
permanent atrial fibrillation;
boolean
C2586056 (UMLS CUI [1])
Anticoagulant therapy Absent
Item
patients who are not on anti-coagulant therapy;
boolean
C0150457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Second degree atrioventricular block Advanced | Complete atrioventricular block Advanced
Item
advanced av block (ii-iii degree av block);
boolean
C0264906 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0151517 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
Patients Submitted Operation on heart valve
Item
patients previously submitted to valvular surgery;
boolean
C0030705 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C0190065 (UMLS CUI [1,3])
Patients Submitted Ablation of Cardiac Atrioventricular Node | Patients Submitted Catheter ablation for atrial fibrillation
Item
patients previously submitted to av or af ablative procedures;
boolean
C0030705 (UMLS CUI [1,1])
C1515023 (UMLS CUI [1,2])
C3275044 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1515023 (UMLS CUI [2,2])
C2702800 (UMLS CUI [2,3])
Age
Item
age < 18 years;
boolean
C0001779 (UMLS CUI [1])
Informed Consent Unwilling
Item
patient not disposed to sign the informed consent;
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Study Subject Participation Status Interferes with Clinical Trial
Item
participation in other studies which could potentially conflict with this study;
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial