ID

25859

Beschreibung

Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT00745706

Link

https://clinicaltrials.gov/show/NCT00745706

Stichworte

Versionen (1)
  1. 22.09.17 22.09.17 -
Hochgeladen am

22. September 2017

DOI

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Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00745706

Englisch

Eligibility Atrial Fibrillation NCT00745706

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18 years old.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
first-time ablation procedure for af.
Beschreibung

Ablation for atrial fibrillation Firstly

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C1279901
symptomatic af which has been refractory to at least one antiarrhythmic medication. "symptomatic" patients should be patients who feel that they are aware of when they are in or out of af. symptoms may include palpitations, shortness of breath, chest pain, fatigue, or other symptoms, or any combination of the symptoms listed above.
Beschreibung

ATRIAL FIBRILLATION SYMPTOMATIC Refractory | Anti-Arrhythmia Agents Quantity | Palpitations | Dyspnea | Chest Pain | Fatigue | Symptoms | Symptoms Combined

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0741283
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0030252
UMLS CUI [4]
C0013404
UMLS CUI [5]
C0008031
UMLS CUI [6]
C0015672
UMLS CUI [7]
C1457887
UMLS CUI [8,1]
C1457887
UMLS CUI [8,2]
C0205195
patients must have paroxysmal or persistent af. paroxysmal patients should have had at least 4 episodes of af in the 6 months prior to assessment/ablation. paroxysmal af is defined as af which spontaneously terminates within 7 days. persistent af is defined as af which sustains for longer than 7 days, or af lasting less than 7 days which requires either pharmacologic or electrical cardioversion.
Beschreibung

Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Paroxysmal atrial fibrillation Episode Quantity | Atrial Fibrillation disease length | Pharmacological cardioversion Patient need for | Electric Countershock Patient need for

Datentyp

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2585653
UMLS CUI [3,1]
C0235480
UMLS CUI [3,2]
C0332189
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0004238
UMLS CUI [4,2]
C0872146
UMLS CUI [5,1]
C1963873
UMLS CUI [5,2]
C0686904
UMLS CUI [6,1]
C0013778
UMLS CUI [6,2]
C0686904
at least one episode of af must have been documented by ecg or holter within 12 months of inclusion in the study.
Beschreibung

Atrial Fibrillation Episode Quantity Electrocardiography | Atrial Fibrillation Episode Quantity Holter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C1623258
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0013801
no contraindication to systemic anticoagulation with heparin or coumadin.
Beschreibung

Medical contraindication Absent Anticoagulation Therapy Systemic | Medical contraindication Absent Heparin | Medical contraindication Absent Coumadin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0003281
UMLS CUI [1,4]
C0205373
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0019134
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0699129
patients must be able and willing to provide written informed consent to participate in the study.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with permanent atrial fibrillation. permanent af is defined as chronic, persisting af (typically more than 1 year) for which cardioversion (pharmacologic or electrical) has failed or will never be attempted.
Beschreibung

Permanent atrial fibrillation | Persistent atrial fibrillation chronic | Pharmacological cardioversion failed | Electric Countershock failed | Pharmacological cardioversion Attempt Absent | Electric Countershock Attempt Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C2586056
UMLS CUI [2,1]
C2585653
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C1963873
UMLS CUI [3,2]
C0231175
UMLS CUI [4,1]
C0013778
UMLS CUI [4,2]
C0231175
UMLS CUI [5,1]
C1963873
UMLS CUI [5,2]
C1516084
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C0013778
UMLS CUI [6,2]
C1516084
UMLS CUI [6,3]
C0332197
patients with af felt to be secondary to an obvious reversible cause.
Beschreibung

Atrial Fibrillation Secondary to Cause Reversible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0205343
patients with contraindications to systemic anticoagulation with heparin or coumadin.
Beschreibung

Medical contraindication Anticoagulation Therapy Systemic | Medical contraindication Heparin | Medical contraindication Coumadin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0003281
UMLS CUI [1,3]
C0205373
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0019134
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0699129
patients who have previously undergone atrial fibrillation ablation.
Beschreibung

Ablation for atrial fibrillation Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C0205156
patients who are or may potentially be pregnant.
Beschreibung

Pregnancy | Childbearing Potential

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
left atrial size > or equal to 55 mm.
Beschreibung

Left atrium cavity size

Datentyp

boolean

Alias
UMLS CUI [1]
C1302212
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT00745706

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 18 years old.
boolean
C0001779 (UMLS CUI [1])
Ablation for atrial fibrillation Firstly
Item
first-time ablation procedure for af.
boolean
C2702800 (UMLS CUI [1,1])
C1279901 (UMLS CUI [1,2])
ATRIAL FIBRILLATION SYMPTOMATIC Refractory | Anti-Arrhythmia Agents Quantity | Palpitations | Dyspnea | Chest Pain | Fatigue | Symptoms | Symptoms Combined
Item
symptomatic af which has been refractory to at least one antiarrhythmic medication. "symptomatic" patients should be patients who feel that they are aware of when they are in or out of af. symptoms may include palpitations, shortness of breath, chest pain, fatigue, or other symptoms, or any combination of the symptoms listed above.
boolean
C0741283 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0003195 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0030252 (UMLS CUI [3])
C0013404 (UMLS CUI [4])
C0008031 (UMLS CUI [5])
C0015672 (UMLS CUI [6])
C1457887 (UMLS CUI [7])
C1457887 (UMLS CUI [8,1])
C0205195 (UMLS CUI [8,2])
Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Paroxysmal atrial fibrillation Episode Quantity | Atrial Fibrillation disease length | Pharmacological cardioversion Patient need for | Electric Countershock Patient need for
Item
patients must have paroxysmal or persistent af. paroxysmal patients should have had at least 4 episodes of af in the 6 months prior to assessment/ablation. paroxysmal af is defined as af which spontaneously terminates within 7 days. persistent af is defined as af which sustains for longer than 7 days, or af lasting less than 7 days which requires either pharmacologic or electrical cardioversion.
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
C0235480 (UMLS CUI [3,1])
C0332189 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0004238 (UMLS CUI [4,1])
C0872146 (UMLS CUI [4,2])
C1963873 (UMLS CUI [5,1])
C0686904 (UMLS CUI [5,2])
C0013778 (UMLS CUI [6,1])
C0686904 (UMLS CUI [6,2])
Atrial Fibrillation Episode Quantity Electrocardiography | Atrial Fibrillation Episode Quantity Holter
Item
at least one episode of af must have been documented by ecg or holter within 12 months of inclusion in the study.
boolean
C0004238 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1623258 (UMLS CUI [1,4])
C0004238 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0013801 (UMLS CUI [2,4])
Medical contraindication Absent Anticoagulation Therapy Systemic | Medical contraindication Absent Heparin | Medical contraindication Absent Coumadin
Item
no contraindication to systemic anticoagulation with heparin or coumadin.
boolean
C1301624 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0003281 (UMLS CUI [1,3])
C0205373 (UMLS CUI [1,4])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0019134 (UMLS CUI [2,3])
C1301624 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0699129 (UMLS CUI [3,3])
Informed Consent
Item
patients must be able and willing to provide written informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Permanent atrial fibrillation | Persistent atrial fibrillation chronic | Pharmacological cardioversion failed | Electric Countershock failed | Pharmacological cardioversion Attempt Absent | Electric Countershock Attempt Absent
Item
patients with permanent atrial fibrillation. permanent af is defined as chronic, persisting af (typically more than 1 year) for which cardioversion (pharmacologic or electrical) has failed or will never be attempted.
boolean
C2586056 (UMLS CUI [1])
C2585653 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C1963873 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0013778 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
C1963873 (UMLS CUI [5,1])
C1516084 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0013778 (UMLS CUI [6,1])
C1516084 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
Atrial Fibrillation Secondary to Cause Reversible
Item
patients with af felt to be secondary to an obvious reversible cause.
boolean
C0004238 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205343 (UMLS CUI [1,4])
Medical contraindication Anticoagulation Therapy Systemic | Medical contraindication Heparin | Medical contraindication Coumadin
Item
patients with contraindications to systemic anticoagulation with heparin or coumadin.
boolean
C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0699129 (UMLS CUI [3,2])
Ablation for atrial fibrillation Previous
Item
patients who have previously undergone atrial fibrillation ablation.
boolean
C2702800 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Pregnancy | Childbearing Potential
Item
patients who are or may potentially be pregnant.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
Left atrium cavity size
Item
left atrial size > or equal to 55 mm.
boolean
C1302212 (UMLS CUI [1])
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