ID

37557

Beschrijving

Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study; ODM derived from: https://clinicaltrials.gov/show/NCT01656772

Link

https://clinicaltrials.gov/show/NCT01656772

Trefwoorden

Versies (1)
  1. 07-08-19 07-08-19 -
Houder van rechten

See clinicaltrials.gov

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7 augustus 2019

DOI

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01656772

Engels

Eligibility Atrial Fibrillation NCT01656772

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
left atrial af ablation procedure requiring the use of a lasso mapping catheter
Beschrijving

Ablation Atrial Fibrillation Left | Mapping Catheter | Other Coding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0547070
UMLS CUI [1,2]
C0004238
UMLS CUI [1,3]
C0443246
UMLS CUI [2,1]
C1283195
UMLS CUI [2,2]
C0085590
UMLS CUI [3]
C3846158
subject must be at least 18 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
subject must be male, female of no childbearing potential, or a female that has a negative pregnancy test prior to randomization
Beschrijving

Gender | Gender Childbearing Potential Absent | Gender Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C3831118
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0427780
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
unable to safely expose subject to a magnetic field
Beschrijving

Exposure to Magnetic Field Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0563533
UMLS CUI [1,3]
C1299582
prior af ablation procedure
Beschrijving

Catheter ablation for atrial fibrillation Previous

Datatype

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0205156
patients with fewer than 4 pvs are excluded
Beschrijving

Pulmonary veins Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034090
UMLS CUI [1,2]
C1265611
patients with persistent af in whom early recurrence of af following cardioversion would preclude completion of the pacing maneuvers described in the protocol or patients with other conditions that would similarly preclude completion of the pacing maneuvers
Beschrijving

Persistent atrial fibrillation | Early Relapse Atrial Fibrillation | Status post Electric Countershock | Artificial Cardiac Pacing Completion Excluded

Datatype

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2,1]
C4055086
UMLS CUI [2,2]
C0004238
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0013778
UMLS CUI [4,1]
C0007168
UMLS CUI [4,2]
C0205197
UMLS CUI [4,3]
C0332196
contraindication to procedure or unable to return for follow-up
Beschrijving

Medical contraindication Procedure | Compliance Follow-up Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0184661
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C3274571
UMLS CUI [2,3]
C1299582
history of clotting disorder, bleeding abnormalities or contraindication to anticoagulation
Beschrijving

Blood Coagulation Disorders | Bleeding tendency | Medical contraindication Anticoagulation Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C1458140
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0003281
actively participating in other cardiac device trial(s)
Beschrijving

Study Subject Participation Status | Cardiac implant device

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0581396
currently pregnant
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
under 18 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
prosthetic valves
Beschrijving

Prosthetic valve

Datatype

boolean

Alias
UMLS CUI [1]
C0336548
atrial abnormalities (thrombus, myxoma or baffle)
Beschrijving

Atrium Abnormality | Thrombus | Myxoma | Baffle

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018792
UMLS CUI [1,2]
C1704258
UMLS CUI [2]
C0087086
UMLS CUI [3]
C0027149
UMLS CUI [4]
C1289790
other exclusions per the investigator
Beschrijving

Exclusion Criteria Additional Research Personnel

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0035173
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Similar models

Eligibility Atrial Fibrillation NCT01656772

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Ablation Atrial Fibrillation Left | Mapping Catheter | Other Coding
Item
left atrial af ablation procedure requiring the use of a lasso mapping catheter
boolean
C0547070 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0443246 (UMLS CUI [1,3])
C1283195 (UMLS CUI [2,1])
C0085590 (UMLS CUI [2,2])
C3846158 (UMLS CUI [3])
Age
Item
subject must be at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Gender | Gender Childbearing Potential Absent | Gender Pregnancy test negative
Item
subject must be male, female of no childbearing potential, or a female that has a negative pregnancy test prior to randomization
boolean
C0079399 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Exposure to Magnetic Field Unable
Item
unable to safely expose subject to a magnetic field
boolean
C0332157 (UMLS CUI [1,1])
C0563533 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Catheter ablation for atrial fibrillation Previous
Item
prior af ablation procedure
boolean
C2702800 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Pulmonary veins Quantity
Item
patients with fewer than 4 pvs are excluded
boolean
C0034090 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Persistent atrial fibrillation | Early Relapse Atrial Fibrillation | Status post Electric Countershock | Artificial Cardiac Pacing Completion Excluded
Item
patients with persistent af in whom early recurrence of af following cardioversion would preclude completion of the pacing maneuvers described in the protocol or patients with other conditions that would similarly preclude completion of the pacing maneuvers
boolean
C2585653 (UMLS CUI [1])
C4055086 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0013778 (UMLS CUI [3,2])
C0007168 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
Medical contraindication Procedure | Compliance Follow-up Unable
Item
contraindication to procedure or unable to return for follow-up
boolean
C1301624 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Blood Coagulation Disorders | Bleeding tendency | Medical contraindication Anticoagulation Therapy
Item
history of clotting disorder, bleeding abnormalities or contraindication to anticoagulation
boolean
C0005779 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0003281 (UMLS CUI [3,2])
Study Subject Participation Status | Cardiac implant device
Item
actively participating in other cardiac device trial(s)
boolean
C2348568 (UMLS CUI [1])
C0581396 (UMLS CUI [2])
Pregnancy
Item
currently pregnant
boolean
C0032961 (UMLS CUI [1])
Age
Item
under 18 years of age
boolean
C0001779 (UMLS CUI [1])
Prosthetic valve
Item
prosthetic valves
boolean
C0336548 (UMLS CUI [1])
Atrium Abnormality | Thrombus | Myxoma | Baffle
Item
atrial abnormalities (thrombus, myxoma or baffle)
boolean
C0018792 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0087086 (UMLS CUI [2])
C0027149 (UMLS CUI [3])
C1289790 (UMLS CUI [4])
Exclusion Criteria Additional Research Personnel
Item
other exclusions per the investigator
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,3])
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