ID

25781

Description

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

Keywords

Versions (1)
  1. 9/19/17 9/19/17 -
Uploaded on

September 19, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00559988

English

Eligibility Atrial Fibrillation NCT00559988

1 forms  
Criteria
Description

Criteria

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

Medical device implantation Planned | Medical device implantation

Data type

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
Description

P wave Amplitude mean | Sinus rhythm | Atrial Fibrillation

Data type

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
Description

CHADS2 score

Data type

boolean

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

Compliance behavior Oral anticoagulants Therapeutic procedure

Data type

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
Description

Ability Self Monitoring

Data type

boolean

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

Exclusion Criteria Main

Data type

boolean

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

Permanent atrial fibrillation

Data type

boolean

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

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

Data type

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
Description

Oral anticoagulants Patient need for | Indication Any

Data type

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
Description

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

Data type

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
Description

Medical contraindication Oral anticoagulants

Data type

boolean

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

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

Data type

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
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Atrial Fibrillation NCT00559988

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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