ID

37556

Descripción

Ventricular Wall Motion Characterization; ODM derived from: https://clinicaltrials.gov/show/NCT01629160

Link

https://clinicaltrials.gov/show/NCT01629160

Palabras clave

Versiones (1)
  1. 7/8/19 7/8/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

7 de agosto de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01629160

Inglés

Eligibility Atrial Fibrillation NCT01629160

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
be in sinus rhythm
Descripción

Sinus rhythm

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232201
have the ability to provide informed consent for study participation and be willing and able to comply with the clinical investigational plan described evaluations
Descripción

Informed Consent | Compliance Evaluation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C1261322
be undergoing mapping and ablation that requires left heart access for either ventricular tachycardia (vt) or atrial fibrillation (af) according to hrs (heart rhythm society)/esc (european society of cardiology)/german national guidelines. the patient needs to have at least one of the following indications for left heart mapping and ablation to be included in the study: a) symptomatic sustained monomorphic vt (smvt), or b) frequent pvcs, non-sustained vt, or vt that is presumed to cause ventricular dysfunction, or c) bundle branch reentrant or interfascicular vts, or d) symptomatic af with indication for ablation per current hrs/esc/german national guidelines in a patient who is either 1) refractory or intolerant to at least one class 1 or class 3 antiarrhythmic medication, or 2) unable/unwilling to take antiarrhythmic drug therapy and chooses ablation as the first line of therapy
Descripción

Mapping | Ablation | Left heart Access Ventricular Tachycardia | Left heart Access Atrial Fibrillation | Indication Mapping Left heart | Indication Ablation Left heart | Monomorphic ventricular tachycardia Symptomatic | Premature ventricular contractions Frequent | Non-sustained ventricular tachycardia | Ventricular Tachycardia Causing Ventricular Dysfunction | Bundle branch reentrant ventricular tachycardia | Ventricular Tachycardia interfascicular | ATRIAL FIBRILLATION SYMPTOMATIC | Indication Ablation | Unresponsive to Anti-Arrhythmia Agents Class Quantity | Intolerance to Anti-Arrhythmia Agents Class Quantity | Anti-Arrhythmia Agents Intake Unable | Anti-Arrhythmia Agents Intake Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1283195
UMLS CUI [2]
C0547070
UMLS CUI [3,1]
C0225809
UMLS CUI [3,2]
C0444454
UMLS CUI [3,3]
C0042514
UMLS CUI [4,1]
C0225809
UMLS CUI [4,2]
C0444454
UMLS CUI [4,3]
C0004238
UMLS CUI [5,1]
C3146298
UMLS CUI [5,2]
C1283195
UMLS CUI [5,3]
C0225809
UMLS CUI [6,1]
C3146298
UMLS CUI [6,2]
C0547070
UMLS CUI [6,3]
C0225809
UMLS CUI [7,1]
C0344431
UMLS CUI [7,2]
C0231220
UMLS CUI [8,1]
C0151636
UMLS CUI [8,2]
C0332183
UMLS CUI [9]
C0750194
UMLS CUI [10,1]
C0042514
UMLS CUI [10,2]
C0678227
UMLS CUI [10,3]
C0242973
UMLS CUI [11]
C2711556
UMLS CUI [12,1]
C0042514
UMLS CUI [12,2]
C0228579
UMLS CUI [13]
C0741283
UMLS CUI [14,1]
C3146298
UMLS CUI [14,2]
C0547070
UMLS CUI [15,1]
C0205269
UMLS CUI [15,2]
C0003195
UMLS CUI [15,3]
C0456387
UMLS CUI [15,4]
C1265611
UMLS CUI [16,1]
C1744706
UMLS CUI [16,2]
C0003195
UMLS CUI [16,3]
C0456387
UMLS CUI [16,4]
C1265611
UMLS CUI [17,1]
C0003195
UMLS CUI [17,2]
C1512806
UMLS CUI [17,3]
C1299582
UMLS CUI [18,1]
C0003195
UMLS CUI [18,2]
C1512806
UMLS CUI [18,3]
C0558080
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
have permanent af
Descripción

Permanent atrial fibrillation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2586056
exhibit cheyne-stokes respiration
Descripción

Cheyne-Stokes Respiration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0008039
have a recent myocardial infarction within 40 days prior to enrollment
Descripción

Myocardial Infarction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027051
have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
Descripción

Cardiac Surgery | Coronary revascularisation | Cardiac Surgery Scheduled | Coronary revascularisation Scheduled

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018821
UMLS CUI [2]
C0877341
UMLS CUI [3,1]
C0018821
UMLS CUI [3,2]
C0205539
UMLS CUI [4,1]
C0877341
UMLS CUI [4,2]
C0205539
have had a recent cva or tia within 3 months prior to enrollment
Descripción

Cerebrovascular accident | Transient Ischemic Attack

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
be less than 18 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
be pregnant
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
be currently participating in any other clinical investigation
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Atrial Fibrillation NCT01629160

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Sinus rhythm
Item
be in sinus rhythm
boolean
C0232201 (UMLS CUI [1])
Informed Consent | Compliance Evaluation
Item
have the ability to provide informed consent for study participation and be willing and able to comply with the clinical investigational plan described evaluations
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
Mapping | Ablation | Left heart Access Ventricular Tachycardia | Left heart Access Atrial Fibrillation | Indication Mapping Left heart | Indication Ablation Left heart | Monomorphic ventricular tachycardia Symptomatic | Premature ventricular contractions Frequent | Non-sustained ventricular tachycardia | Ventricular Tachycardia Causing Ventricular Dysfunction | Bundle branch reentrant ventricular tachycardia | Ventricular Tachycardia interfascicular | ATRIAL FIBRILLATION SYMPTOMATIC | Indication Ablation | Unresponsive to Anti-Arrhythmia Agents Class Quantity | Intolerance to Anti-Arrhythmia Agents Class Quantity | Anti-Arrhythmia Agents Intake Unable | Anti-Arrhythmia Agents Intake Unwilling
Item
be undergoing mapping and ablation that requires left heart access for either ventricular tachycardia (vt) or atrial fibrillation (af) according to hrs (heart rhythm society)/esc (european society of cardiology)/german national guidelines. the patient needs to have at least one of the following indications for left heart mapping and ablation to be included in the study: a) symptomatic sustained monomorphic vt (smvt), or b) frequent pvcs, non-sustained vt, or vt that is presumed to cause ventricular dysfunction, or c) bundle branch reentrant or interfascicular vts, or d) symptomatic af with indication for ablation per current hrs/esc/german national guidelines in a patient who is either 1) refractory or intolerant to at least one class 1 or class 3 antiarrhythmic medication, or 2) unable/unwilling to take antiarrhythmic drug therapy and chooses ablation as the first line of therapy
boolean
C1283195 (UMLS CUI [1])
C0547070 (UMLS CUI [2])
C0225809 (UMLS CUI [3,1])
C0444454 (UMLS CUI [3,2])
C0042514 (UMLS CUI [3,3])
C0225809 (UMLS CUI [4,1])
C0444454 (UMLS CUI [4,2])
C0004238 (UMLS CUI [4,3])
C3146298 (UMLS CUI [5,1])
C1283195 (UMLS CUI [5,2])
C0225809 (UMLS CUI [5,3])
C3146298 (UMLS CUI [6,1])
C0547070 (UMLS CUI [6,2])
C0225809 (UMLS CUI [6,3])
C0344431 (UMLS CUI [7,1])
C0231220 (UMLS CUI [7,2])
C0151636 (UMLS CUI [8,1])
C0332183 (UMLS CUI [8,2])
C0750194 (UMLS CUI [9])
C0042514 (UMLS CUI [10,1])
C0678227 (UMLS CUI [10,2])
C0242973 (UMLS CUI [10,3])
C2711556 (UMLS CUI [11])
C0042514 (UMLS CUI [12,1])
C0228579 (UMLS CUI [12,2])
C0741283 (UMLS CUI [13])
C3146298 (UMLS CUI [14,1])
C0547070 (UMLS CUI [14,2])
C0205269 (UMLS CUI [15,1])
C0003195 (UMLS CUI [15,2])
C0456387 (UMLS CUI [15,3])
C1265611 (UMLS CUI [15,4])
C1744706 (UMLS CUI [16,1])
C0003195 (UMLS CUI [16,2])
C0456387 (UMLS CUI [16,3])
C1265611 (UMLS CUI [16,4])
C0003195 (UMLS CUI [17,1])
C1512806 (UMLS CUI [17,2])
C1299582 (UMLS CUI [17,3])
C0003195 (UMLS CUI [18,1])
C1512806 (UMLS CUI [18,2])
C0558080 (UMLS CUI [18,3])
Item Group
C0680251 (UMLS CUI)
Permanent atrial fibrillation
Item
have permanent af
boolean
C2586056 (UMLS CUI [1])
Cheyne-Stokes Respiration
Item
exhibit cheyne-stokes respiration
boolean
C0008039 (UMLS CUI [1])
Myocardial Infarction
Item
have a recent myocardial infarction within 40 days prior to enrollment
boolean
C0027051 (UMLS CUI [1])
Cardiac Surgery | Coronary revascularisation | Cardiac Surgery Scheduled | Coronary revascularisation Scheduled
Item
have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
boolean
C0018821 (UMLS CUI [1])
C0877341 (UMLS CUI [2])
C0018821 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
C0877341 (UMLS CUI [4,1])
C0205539 (UMLS CUI [4,2])
Cerebrovascular accident | Transient Ischemic Attack
Item
have had a recent cva or tia within 3 months prior to enrollment
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Age
Item
be less than 18 years of age
boolean
C0001779 (UMLS CUI [1])
Pregnancy
Item
be pregnant
boolean
C0032961 (UMLS CUI [1])
Study Subject Participation Status
Item
be currently participating in any other clinical investigation
boolean
C2348568 (UMLS CUI [1])
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