ID

16159

Beschreibung

TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics; ODM derived from: https://clinicaltrials.gov/show/NCT00279981

Link

https://clinicaltrials.gov/show/NCT00279981

Stichworte

Versionen (1)
  1. 03.07.16 03.07.16 -
Hochgeladen am

3. Juli 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT00279981

Englisch

Eligibility Atrial Fibrillation NCT00279981

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject provides written informed consent and privacy/protection authorization.
Beschreibung

Informed Consent | confidentiality Authorization

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0009669
UMLS CUI [2,2]
C1524004
subjects 65 years of age or older.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
subjects with age >18 and < 65 years and one of the following stroke risk factors:
Beschreibung

Age | Cerebrovascular accident risk factors

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0038454
UMLS CUI [2,2]
C0035648
prior stroke or tia
Beschreibung

Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
diagnosis of hypertension (htn)
Beschreibung

Hypertensive disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
diagnosis of diabetes mellitus (dm)
Beschreibung

Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
diagnosis of congestive heart failure (chf)
Beschreibung

Congestive heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0018802
subjects who meet the class i/class ii indications for a dual chamber implantable pulse generator or dual chamber implanted cardioverter defibrillator device
Beschreibung

Indication PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | Indication Cardioverter-defibrillator, dual chamber (implantable)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0493526
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0993732
• subjects who meet the criteria for indication of a dual chamber resynchronization device with bi-ventricular pacing (moderate to severe chf symptoms [nyha class iii-iv] despite optimal medical therapy, left ventricular ejection fraction ≤ 35%, and a qrs duration ≥130 ms)13.
Beschreibung

Indication Cardiac Resynchronization Therapy Devices | Atrio-Biventricular Pacing | Congestive heart failure Symptoms Moderate | Congestive heart failure Symptoms Severe | Therapeutic procedure Optimal | Left ventricular ejection fraction | QRS complex duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2936377
UMLS CUI [2]
C2936372
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1457887
UMLS CUI [3,3]
C0205081
UMLS CUI [4,1]
C0018802
UMLS CUI [4,2]
C1457887
UMLS CUI [4,3]
C0205082
UMLS CUI [5,1]
C0087111
UMLS CUI [5,2]
C2698651
UMLS CUI [6]
C0428772
UMLS CUI [7]
C0429025
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who are to receive a replacement ipg, icd or crt device.
Beschreibung

Replacement of electronic heart device, pulse generator | Replacement of cardioverter defibrillator | Surgical Replantation Cardiac Resynchronization Therapy Devices

Datentyp

boolean

Alias
UMLS CUI [1]
C0189853
UMLS CUI [2]
C1998273
UMLS CUI [3,1]
C0035139
UMLS CUI [3,2]
C2936377
subjects with chronic (permanent) at/af.
Beschreibung

Atrial tachycardia Permanent | Permanent atrial fibrillation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0546959
UMLS CUI [1,2]
C0205355
UMLS CUI [2]
C2586056
subjects with a history of av nodal dependent arrhythmias.
Beschreibung

AV node arrhythmia

Datentyp

boolean

Alias
UMLS CUI [1]
C0264896
subjects with a terminal illness who are not expected to survive more than 6 months.
Beschreibung

Terminal illness | Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0679247
UMLS CUI [2]
C0023671
subjects who are unwilling or unable to cooperate or give written informed consent and privacy/protection authorization, or subjects whose legal representatives or legal guardians refuse to give informed consent or privacy/protection authorization.
Beschreibung

Compliance behavior Limited | Informed Consent Unable | Informed Consent Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0558080
subjects currently receiving treatment in another drug and/or device study which could affect the outcome of the trial.
Beschreibung

Study Subject Participation Status Affecting research results | Investigational New Drugs | Investigational Medical Device

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
subjects who are or will be inaccessible for follow-up at a qualified study center.
Beschreibung

follow-up Patient unavailable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C1301818
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Ähnliche Modelle

Eligibility Atrial Fibrillation NCT00279981

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | confidentiality Authorization
Item
subject provides written informed consent and privacy/protection authorization.
boolean
C0021430 (UMLS CUI [1])
C0009669 (UMLS CUI [2,1])
C1524004 (UMLS CUI [2,2])
Age
Item
subjects 65 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Age | Cerebrovascular accident risk factors
Item
subjects with age >18 and < 65 years and one of the following stroke risk factors:
boolean
C0001779 (UMLS CUI [1])
C0038454 (UMLS CUI [2,1])
C0035648 (UMLS CUI [2,2])
Cerebrovascular accident | Transient Ischemic Attack
Item
prior stroke or tia
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Hypertensive disease
Item
diagnosis of hypertension (htn)
boolean
C0020538 (UMLS CUI [1])
Diabetes Mellitus
Item
diagnosis of diabetes mellitus (dm)
boolean
C0011849 (UMLS CUI [1])
Congestive heart failure
Item
diagnosis of congestive heart failure (chf)
boolean
C0018802 (UMLS CUI [1])
Indication PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | Indication Cardioverter-defibrillator, dual chamber (implantable)
Item
subjects who meet the class i/class ii indications for a dual chamber implantable pulse generator or dual chamber implanted cardioverter defibrillator device
boolean
C3146298 (UMLS CUI [1,1])
C0493526 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0993732 (UMLS CUI [2,2])
Indication Cardiac Resynchronization Therapy Devices | Atrio-Biventricular Pacing | Congestive heart failure Symptoms Moderate | Congestive heart failure Symptoms Severe | Therapeutic procedure Optimal | Left ventricular ejection fraction | QRS complex duration
Item
• subjects who meet the criteria for indication of a dual chamber resynchronization device with bi-ventricular pacing (moderate to severe chf symptoms [nyha class iii-iv] despite optimal medical therapy, left ventricular ejection fraction ≤ 35%, and a qrs duration ≥130 ms)13.
boolean
C3146298 (UMLS CUI [1,1])
C2936377 (UMLS CUI [1,2])
C2936372 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
C0205081 (UMLS CUI [3,3])
C0018802 (UMLS CUI [4,1])
C1457887 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C0087111 (UMLS CUI [5,1])
C2698651 (UMLS CUI [5,2])
C0428772 (UMLS CUI [6])
C0429025 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Replacement of electronic heart device, pulse generator | Replacement of cardioverter defibrillator | Surgical Replantation Cardiac Resynchronization Therapy Devices
Item
subjects who are to receive a replacement ipg, icd or crt device.
boolean
C0189853 (UMLS CUI [1])
C1998273 (UMLS CUI [2])
C0035139 (UMLS CUI [3,1])
C2936377 (UMLS CUI [3,2])
Atrial tachycardia Permanent | Permanent atrial fibrillation
Item
subjects with chronic (permanent) at/af.
boolean
C0546959 (UMLS CUI [1,1])
C0205355 (UMLS CUI [1,2])
C2586056 (UMLS CUI [2])
AV node arrhythmia
Item
subjects with a history of av nodal dependent arrhythmias.
boolean
C0264896 (UMLS CUI [1])
Terminal illness | Life Expectancy
Item
subjects with a terminal illness who are not expected to survive more than 6 months.
boolean
C0679247 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Compliance behavior Limited | Informed Consent Unable | Informed Consent Unwilling
Item
subjects who are unwilling or unable to cooperate or give written informed consent and privacy/protection authorization, or subjects whose legal representatives or legal guardians refuse to give informed consent or privacy/protection authorization.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Study Subject Participation Status Affecting research results | Investigational New Drugs | Investigational Medical Device
Item
subjects currently receiving treatment in another drug and/or device study which could affect the outcome of the trial.
boolean
C2348568 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
follow-up Patient unavailable
Item
subjects who are or will be inaccessible for follow-up at a qualified study center.
boolean
C1522577 (UMLS CUI [1,1])
C1301818 (UMLS CUI [1,2])
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