ID

37467

Description

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

Keywords

Versions (1)
  1. 7/30/19 7/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 30, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01095952

English

Eligibility Atrial Fibrillation NCT01095952

1 forms  
Inclusion Criteria
Description

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:
Description

Paroxysmal atrial fibrillation | Persistent atrial fibrillation

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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.
Description

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

Data type

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
Description

Exclusion Criteria

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

Criteria Fulfill

Data type

boolean

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

Permanent atrial fibrillation

Data type

boolean

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

Anticoagulant therapy Absent

Data type

boolean

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

Second degree atrioventricular block Advanced | Complete atrioventricular block Advanced

Data type

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;
Description

Patients Submitted Operation on heart valve

Data type

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;
Description

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

Data type

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;
Description

Age

Data type

boolean

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

Informed Consent Unwilling

Data type

boolean

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

Study Subject Participation Status Interferes with Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
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Similar models

Eligibility Atrial Fibrillation NCT01095952

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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