ID

25781

Beschreibung

Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk; ODM derived from: https://clinicaltrials.gov/show/NCT00559988

Link

https://clinicaltrials.gov/show/NCT00559988

Stichworte

Versionen (1)
  1. 19.09.17 19.09.17 -
Hochgeladen am

19. September 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00559988

Englisch

Eligibility Atrial Fibrillation NCT00559988

1 Formulare  
Criteria
Beschreibung

Criteria

candidates for implantation of, or already implanted with, a biotronik lumax hf-t or dr-t device
Beschreibung

Medical device implantation Planned | Medical device implantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877318
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0877318
documented p wave mean amplitude ≥ 1.0 mv (sinus rhythm) or ≥ 0.5 mv (af) at enrollment, if previously implanted
Beschreibung

P wave Amplitude mean | Sinus rhythm | Atrial Fibrillation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0429084
UMLS CUI [1,2]
C2346753
UMLS CUI [1,3]
C0444504
UMLS CUI [2]
C0232201
UMLS CUI [3]
C0004238
chads2 risk score ≥ 1
Beschreibung

CHADS2 score

Datentyp

boolean

Alias
UMLS CUI [1]
C2585876
able and willing to follow oac therapy if the indication develops during the course of the trial
Beschreibung

Compliance behavior Oral anticoagulants Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0354604
UMLS CUI [1,3]
C0087111
able to utilize the hm throughout the study
Beschreibung

Ability Self Monitoring

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0588436
key exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
permanent af
Beschreibung

Permanent atrial fibrillation

Datentyp

boolean

Alias
UMLS CUI [1]
C2586056
history of stroke, transient ischemic attack (tia) or systemic embolism and documented af or afl
Beschreibung

Cerebrovascular accident | Transient Ischemic Attack | EMBOLISM, SYSTEMIC ARTERIAL | Atrial Fibrillation | Atrial Flutter

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
UMLS CUI [3]
C0149876
UMLS CUI [4]
C0004238
UMLS CUI [5]
C0004239
currently requiring oac therapy for any indication
Beschreibung

Oral anticoagulants Patient need for | Indication Any

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0354604
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1552551
patients who underwent successful af ablation (sinus rhythm restored) and have not completed a minimum of 3 months of oac therapy
Beschreibung

Ablation for atrial fibrillation Successful | Normal sinus rhythm | Oral anticoagulants Therapeutic procedure Incomplete

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2702800
UMLS CUI [1,2]
C1272703
UMLS CUI [2]
C0232202
UMLS CUI [3,1]
C0354604
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0205257
known, current contraindication to use of eligible oac
Beschreibung

Medical contraindication Oral anticoagulants

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0354604
long qt or brugada syndrome as the sole indication for device implantation
Beschreibung

Long QT Syndrome | Brugada Syndrome | Indication Alone Medical device implantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0023976
UMLS CUI [2]
C1142166
UMLS CUI [3,1]
C3146298
UMLS CUI [3,2]
C0205171
UMLS CUI [3,3]
C0877318
life expectancy less than the expected term of the study
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT00559988

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Medical device implantation Planned | Medical device implantation
Item
candidates for implantation of, or already implanted with, a biotronik lumax hf-t or dr-t device
boolean
C0877318 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0877318 (UMLS CUI [2])
P wave Amplitude mean | Sinus rhythm | Atrial Fibrillation
Item
documented p wave mean amplitude ≥ 1.0 mv (sinus rhythm) or ≥ 0.5 mv (af) at enrollment, if previously implanted
boolean
C0429084 (UMLS CUI [1,1])
C2346753 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
C0232201 (UMLS CUI [2])
C0004238 (UMLS CUI [3])
CHADS2 score
Item
chads2 risk score ≥ 1
boolean
C2585876 (UMLS CUI [1])
Compliance behavior Oral anticoagulants Therapeutic procedure
Item
able and willing to follow oac therapy if the indication develops during the course of the trial
boolean
C1321605 (UMLS CUI [1,1])
C0354604 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Ability Self Monitoring
Item
able to utilize the hm throughout the study
boolean
C0085732 (UMLS CUI [1,1])
C0588436 (UMLS CUI [1,2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Permanent atrial fibrillation
Item
permanent af
boolean
C2586056 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack | EMBOLISM, SYSTEMIC ARTERIAL | Atrial Fibrillation | Atrial Flutter
Item
history of stroke, transient ischemic attack (tia) or systemic embolism and documented af or afl
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
C0149876 (UMLS CUI [3])
C0004238 (UMLS CUI [4])
C0004239 (UMLS CUI [5])
Oral anticoagulants Patient need for | Indication Any
Item
currently requiring oac therapy for any indication
boolean
C0354604 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
Ablation for atrial fibrillation Successful | Normal sinus rhythm | Oral anticoagulants Therapeutic procedure Incomplete
Item
patients who underwent successful af ablation (sinus rhythm restored) and have not completed a minimum of 3 months of oac therapy
boolean
C2702800 (UMLS CUI [1,1])
C1272703 (UMLS CUI [1,2])
C0232202 (UMLS CUI [2])
C0354604 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0205257 (UMLS CUI [3,3])
Medical contraindication Oral anticoagulants
Item
known, current contraindication to use of eligible oac
boolean
C1301624 (UMLS CUI [1,1])
C0354604 (UMLS CUI [1,2])
Long QT Syndrome | Brugada Syndrome | Indication Alone Medical device implantation
Item
long qt or brugada syndrome as the sole indication for device implantation
boolean
C0023976 (UMLS CUI [1])
C1142166 (UMLS CUI [2])
C3146298 (UMLS CUI [3,1])
C0205171 (UMLS CUI [3,2])
C0877318 (UMLS CUI [3,3])
Life Expectancy
Item
life expectancy less than the expected term of the study
boolean
C0023671 (UMLS CUI [1])
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