ID

29468

Beskrivning

Data Collection Study of Wedge Pressure Data in Patients With CRT-D Devices; ODM derived from: https://clinicaltrials.gov/show/NCT00811551

Länk

https://clinicaltrials.gov/show/NCT00811551

Nyckelord

Versioner (1)
  1. 2018-03-28 2018-03-28 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

28 mars 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Heart Failure NCT00811551

Engelsk

Eligibility Heart Failure NCT00811551

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a sjm promote crt-d (model 3207 or other model with similar functioning) system that was implanted at least 4 months prior to enrollment for an approved indication per acc/aha/hrs guidelines.
Beskrivning

Indication Implantation of CRT-D

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1135480
have the ability to provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluation.
Beskrivning

Informed Consent | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
have legally marketed bipolar right atrial and true bipolar right ventricular pacing defibrillation leads, and a legally marketed endocardial bipolar lv lead.
Beskrivning

Endocardial defibrillation lead Right atrium Bipolar | Endocardial defibrillation lead Right ventricle Bipolar | Endocardial defibrillation lead Left ventricle Bipolar

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3874720
UMLS CUI [1,2]
C0225844
UMLS CUI [1,3]
C0443156
UMLS CUI [2,1]
C3874720
UMLS CUI [2,2]
C0225883
UMLS CUI [2,3]
C0443156
UMLS CUI [3,1]
C3874720
UMLS CUI [3,2]
C0225897
UMLS CUI [3,3]
C0443156
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
be less than 18 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
have any medical condition that would interfere with intra-thoracic measurements such as end-stage pulmonary disease, advanced interstitial pulmonary disease, or frequent episodes of pneumonia.
Beskrivning

Medical condition Interferes with Intervention thoracic | Lung disease End-stage | Interstitial Lung Diseases Advanced | Pneumonia Episode Frequent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0184661
UMLS CUI [1,4]
C0817096
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0205088
UMLS CUI [3,1]
C0206062
UMLS CUI [3,2]
C0205179
UMLS CUI [4,1]
C0032285
UMLS CUI [4,2]
C0332189
UMLS CUI [4,3]
C0332183
have a contraindication for right heart catheterization.
Beskrivning

Medical contraindication Catheterization of right heart

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0189896
have a contraindication for the delivery of iv nitroglycerin.
Beskrivning

Medical contraindication Nitroglycerin Intravenous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0017887
UMLS CUI [1,3]
C1522726
be pregnant or planning a pregnancy for the duration of their study participation.
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
be currently participating in a clinical investigation that includes an active treatment arm.
Beskrivning

Study Subject Participation Status | Treatment Arm Included

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1522541
UMLS CUI [2,2]
C0332257
have a life expectancy of less than 12 months due to any condition.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
be unable to perform the valsalva maneuver with airway pressure > 40 mm hg for ≥10 seconds.
Beskrivning

Valsalva Maneuver Airway pressure Perform Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042293
UMLS CUI [1,2]
C0428719
UMLS CUI [1,3]
C0884358
UMLS CUI [1,4]
C1299582
are pacemaker dependent, where cessation of pacemaker function consistently results in syncope or ventricular asystole.
Beskrivning

Pacemaker Dependence | Pacemaker Cessation Resulting in Syncope | Pacemaker Cessation Resulting in Ventricular asystole

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C0439857
UMLS CUI [2,1]
C0030163
UMLS CUI [2,2]
C1880019
UMLS CUI [2,3]
C0332294
UMLS CUI [2,4]
C0039070
UMLS CUI [3,1]
C0030163
UMLS CUI [3,2]
C1880019
UMLS CUI [3,3]
C0332294
UMLS CUI [3,4]
C0018790
Tillbaka till toppen

Similar models

Eligibility Heart Failure NCT00811551

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Indication Implantation of CRT-D
Item
have a sjm promote crt-d (model 3207 or other model with similar functioning) system that was implanted at least 4 months prior to enrollment for an approved indication per acc/aha/hrs guidelines.
boolean
C3146298 (UMLS CUI [1,1])
C1135480 (UMLS CUI [1,2])
Informed Consent | Protocol Compliance
Item
have the ability to provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluation.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Endocardial defibrillation lead Right atrium Bipolar | Endocardial defibrillation lead Right ventricle Bipolar | Endocardial defibrillation lead Left ventricle Bipolar
Item
have legally marketed bipolar right atrial and true bipolar right ventricular pacing defibrillation leads, and a legally marketed endocardial bipolar lv lead.
boolean
C3874720 (UMLS CUI [1,1])
C0225844 (UMLS CUI [1,2])
C0443156 (UMLS CUI [1,3])
C3874720 (UMLS CUI [2,1])
C0225883 (UMLS CUI [2,2])
C0443156 (UMLS CUI [2,3])
C3874720 (UMLS CUI [3,1])
C0225897 (UMLS CUI [3,2])
C0443156 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Age
Item
be less than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Medical condition Interferes with Intervention thoracic | Lung disease End-stage | Interstitial Lung Diseases Advanced | Pneumonia Episode Frequent
Item
have any medical condition that would interfere with intra-thoracic measurements such as end-stage pulmonary disease, advanced interstitial pulmonary disease, or frequent episodes of pneumonia.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C0817096 (UMLS CUI [1,4])
C0024115 (UMLS CUI [2,1])
C0205088 (UMLS CUI [2,2])
C0206062 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C0032285 (UMLS CUI [4,1])
C0332189 (UMLS CUI [4,2])
C0332183 (UMLS CUI [4,3])
Medical contraindication Catheterization of right heart
Item
have a contraindication for right heart catheterization.
boolean
C1301624 (UMLS CUI [1,1])
C0189896 (UMLS CUI [1,2])
Medical contraindication Nitroglycerin Intravenous
Item
have a contraindication for the delivery of iv nitroglycerin.
boolean
C1301624 (UMLS CUI [1,1])
C0017887 (UMLS CUI [1,2])
C1522726 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned
Item
be pregnant or planning a pregnancy for the duration of their study participation.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Study Subject Participation Status | Treatment Arm Included
Item
be currently participating in a clinical investigation that includes an active treatment arm.
boolean
C2348568 (UMLS CUI [1])
C1522541 (UMLS CUI [2,1])
C0332257 (UMLS CUI [2,2])
Life Expectancy
Item
have a life expectancy of less than 12 months due to any condition.
boolean
C0023671 (UMLS CUI [1])
Valsalva Maneuver Airway pressure Perform Unable
Item
be unable to perform the valsalva maneuver with airway pressure > 40 mm hg for ≥10 seconds.
boolean
C0042293 (UMLS CUI [1,1])
C0428719 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Pacemaker Dependence | Pacemaker Cessation Resulting in Syncope | Pacemaker Cessation Resulting in Ventricular asystole
Item
are pacemaker dependent, where cessation of pacemaker function consistently results in syncope or ventricular asystole.
boolean
C0030163 (UMLS CUI [1,1])
C0439857 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2,1])
C1880019 (UMLS CUI [2,2])
C0332294 (UMLS CUI [2,3])
C0039070 (UMLS CUI [2,4])
C0030163 (UMLS CUI [3,1])
C1880019 (UMLS CUI [3,2])
C0332294 (UMLS CUI [3,3])
C0018790 (UMLS CUI [3,4])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial