ID

34857

Description

The REACT-ICD Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02439424

Lien

https://clinicaltrials.gov/show/NCT02439424

Mots-clés

Versions (1)
  1. 01/02/2019 01/02/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

1 février 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Atrial Tachyarrhythmia NCT02439424

Anglais

Eligibility Atrial Tachyarrhythmia NCT02439424

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female patients
Description

Gender

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
≥18 years old (no upper age limit)
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
previously implanted with a dual-chamber medtronic icd with capability of atrial antitachycardia pacing; specifically, reactive atp™ at least 9 months previously (six months data collection and implant occurring at least 3 months previously to allow healing and establishment of stable sensing)
Description

Dual-chamber implantable defibrillator | Antitachycardia Pacing atrial | Antitachycardia Pacing Reactive

Type de données

boolean

Alias
UMLS CUI [1]
C0494014
UMLS CUI [2,1]
C3640047
UMLS CUI [2,2]
C0018792
UMLS CUI [3,1]
C3640047
UMLS CUI [3,2]
C0205332
measured p wave in sinus rhythm of at least 0.8 mv
Description

P wave Measured Sinus rhythm

Type de données

boolean

Alias
UMLS CUI [1,1]
C0429084
UMLS CUI [1,2]
C0444706
UMLS CUI [1,3]
C0232201
>=6 months at/af burden data available, either from carelink® or in-office interrogation
Description

Atrial tachycardia Burden Duration Data | Atrial Fibrillation Burden Duration Data

Type de données

boolean

Alias
UMLS CUI [1,1]
C0546959
UMLS CUI [1,2]
C2828008
UMLS CUI [1,3]
C0449238
UMLS CUI [1,4]
C1511726
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C2828008
UMLS CUI [2,3]
C0449238
UMLS CUI [2,4]
C1511726
>=1.0% at/af burden (hours in atrial fibrillation/total hours monitored) in the last 6 months
Description

Atrial tachycardia Burden Percentage | Atrial Fibrillation Burden Percentage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0546959
UMLS CUI [1,2]
C2828008
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C2828008
UMLS CUI [2,3]
C0439165
no change in antiarrhythmic drug therapy (vaughan-williams class i or iii) in the last 6 months
Description

Anti-Arrhythmia Agents Class unchanged

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0456387
UMLS CUI [1,3]
C0442739
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
persistent or permanent at/af (af burden >95%)
Description

Atrial tachycardia Persistent | Atrial tachycardia Permanent | Persistent atrial fibrillation | Permanent atrial fibrillation | Atrial Fibrillation Burden Percentage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0546959
UMLS CUI [1,2]
C0205322
UMLS CUI [2,1]
C0546959
UMLS CUI [2,2]
C0205355
UMLS CUI [3]
C2585653
UMLS CUI [4]
C2586056
UMLS CUI [5,1]
C0004238
UMLS CUI [5,2]
C2828008
UMLS CUI [5,3]
C0439165
cardioversion for atrial fibrillation or atrial flutter within the last 6 months, either intentional or as a result of a tachyarrhythmia therapy
Description

Cardioversion Atrial Fibrillation | Cardioversion Atrial Flutter | Therapeutic procedure Tachyarrhythmia

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013778
UMLS CUI [1,2]
C0004238
UMLS CUI [2,1]
C0013778
UMLS CUI [2,2]
C0004239
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0080203
reactive atp™ previously programmed on
Description

Antitachycardia Pacing Reactive Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C3640047
UMLS CUI [1,2]
C0205332
UMLS CUI [1,3]
C0205156
measured p waves in sinus rhythm consistently <0.8 mv on repeat measurements.
Description

P wave Measured Sinus rhythm

Type de données

boolean

Alias
UMLS CUI [1,1]
C0429084
UMLS CUI [1,2]
C0444706
UMLS CUI [1,3]
C0232201
unresolved artifactual at/af detection due to far-field r wave or other oversensing
Description

Arrhythmia Artifact Detection Atrial tachycardia | Arrhythmia Artifact Detection Atrial Fibrillation | Far-field R-wave sensing Increased

Type de données

boolean

Alias
UMLS CUI [1,1]
C2828131
UMLS CUI [1,2]
C1511790
UMLS CUI [1,3]
C0546959
UMLS CUI [2,1]
C2828131
UMLS CUI [2,2]
C1511790
UMLS CUI [2,3]
C0004238
UMLS CUI [3,1]
C1611749
UMLS CUI [3,2]
C0205217
expected generator change or other device surgery within six months
Description

Device Surgical repair Expected

Type de données

boolean

Alias
UMLS CUI [1,1]
C0025080
UMLS CUI [1,2]
C0374711
UMLS CUI [1,3]
C1517001
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Similar models

Eligibility Atrial Tachyarrhythmia NCT02439424

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
male and female patients
boolean
C0079399 (UMLS CUI [1])
Age
Item
≥18 years old (no upper age limit)
boolean
C0001779 (UMLS CUI [1])
Dual-chamber implantable defibrillator | Antitachycardia Pacing atrial | Antitachycardia Pacing Reactive
Item
previously implanted with a dual-chamber medtronic icd with capability of atrial antitachycardia pacing; specifically, reactive atp™ at least 9 months previously (six months data collection and implant occurring at least 3 months previously to allow healing and establishment of stable sensing)
boolean
C0494014 (UMLS CUI [1])
C3640047 (UMLS CUI [2,1])
C0018792 (UMLS CUI [2,2])
C3640047 (UMLS CUI [3,1])
C0205332 (UMLS CUI [3,2])
P wave Measured Sinus rhythm
Item
measured p wave in sinus rhythm of at least 0.8 mv
boolean
C0429084 (UMLS CUI [1,1])
C0444706 (UMLS CUI [1,2])
C0232201 (UMLS CUI [1,3])
Atrial tachycardia Burden Duration Data | Atrial Fibrillation Burden Duration Data
Item
>=6 months at/af burden data available, either from carelink® or in-office interrogation
boolean
C0546959 (UMLS CUI [1,1])
C2828008 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1511726 (UMLS CUI [1,4])
C0004238 (UMLS CUI [2,1])
C2828008 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C1511726 (UMLS CUI [2,4])
Atrial tachycardia Burden Percentage | Atrial Fibrillation Burden Percentage
Item
>=1.0% at/af burden (hours in atrial fibrillation/total hours monitored) in the last 6 months
boolean
C0546959 (UMLS CUI [1,1])
C2828008 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0004238 (UMLS CUI [2,1])
C2828008 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Anti-Arrhythmia Agents Class unchanged
Item
no change in antiarrhythmic drug therapy (vaughan-williams class i or iii) in the last 6 months
boolean
C0003195 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Atrial tachycardia Persistent | Atrial tachycardia Permanent | Persistent atrial fibrillation | Permanent atrial fibrillation | Atrial Fibrillation Burden Percentage
Item
persistent or permanent at/af (af burden >95%)
boolean
C0546959 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0546959 (UMLS CUI [2,1])
C0205355 (UMLS CUI [2,2])
C2585653 (UMLS CUI [3])
C2586056 (UMLS CUI [4])
C0004238 (UMLS CUI [5,1])
C2828008 (UMLS CUI [5,2])
C0439165 (UMLS CUI [5,3])
Cardioversion Atrial Fibrillation | Cardioversion Atrial Flutter | Therapeutic procedure Tachyarrhythmia
Item
cardioversion for atrial fibrillation or atrial flutter within the last 6 months, either intentional or as a result of a tachyarrhythmia therapy
boolean
C0013778 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0013778 (UMLS CUI [2,1])
C0004239 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0080203 (UMLS CUI [3,2])
Antitachycardia Pacing Reactive Previous
Item
reactive atp™ previously programmed on
boolean
C3640047 (UMLS CUI [1,1])
C0205332 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
P wave Measured Sinus rhythm
Item
measured p waves in sinus rhythm consistently <0.8 mv on repeat measurements.
boolean
C0429084 (UMLS CUI [1,1])
C0444706 (UMLS CUI [1,2])
C0232201 (UMLS CUI [1,3])
Arrhythmia Artifact Detection Atrial tachycardia | Arrhythmia Artifact Detection Atrial Fibrillation | Far-field R-wave sensing Increased
Item
unresolved artifactual at/af detection due to far-field r wave or other oversensing
boolean
C2828131 (UMLS CUI [1,1])
C1511790 (UMLS CUI [1,2])
C0546959 (UMLS CUI [1,3])
C2828131 (UMLS CUI [2,1])
C1511790 (UMLS CUI [2,2])
C0004238 (UMLS CUI [2,3])
C1611749 (UMLS CUI [3,1])
C0205217 (UMLS CUI [3,2])
Device Surgical repair Expected
Item
expected generator change or other device surgery within six months
boolean
C0025080 (UMLS CUI [1,1])
C0374711 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
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