ID

29468

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00811551

Palabras clave

Versiones (1)
  1. 28/3/18 28/3/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

28 de marzo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00811551

Inglés

Eligibility Heart Failure NCT00811551

1 formularios  
Inclusion Criteria
Descripción

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.
Descripción

Indication Implantation of CRT-D

Tipo de datos

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.
Descripción

Informed Consent | Protocol Compliance

Tipo de datos

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.
Descripción

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

Tipo de datos

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
Descripción

Exclusion Criteria

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

Age

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Medical contraindication Catheterization of right heart

Tipo de datos

boolean

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

Medical contraindication Nitroglycerin Intravenous

Tipo de datos

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.
Descripción

Pregnancy | Pregnancy, Planned

Tipo de datos

boolean

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

Study Subject Participation Status | Treatment Arm Included

Tipo de datos

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.
Descripción

Life Expectancy

Tipo de datos

boolean

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

Valsalva Maneuver Airway pressure Perform Unable

Tipo de datos

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.
Descripción

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

Tipo de datos

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
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Similar models

Eligibility Heart Failure NCT00811551

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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