ID

29468

Description

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

Lien

https://clinicaltrials.gov/show/NCT00811551

Mots-clés

Versions (1)
  1. 28/03/2018 28/03/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

28 mars 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Heart Failure NCT00811551

Anglais

Eligibility Heart Failure NCT00811551

1 Formulaires  
Inclusion Criteria
Description

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.
Description

Indication Implantation of CRT-D

Type de données

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.
Description

Informed Consent | Protocol Compliance

Type de données

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.
Description

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

Type de données

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
Description

Exclusion Criteria

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

Age

Type de données

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.
Description

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

Type de données

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.
Description

Medical contraindication Catheterization of right heart

Type de données

boolean

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

Medical contraindication Nitroglycerin Intravenous

Type de données

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.
Description

Pregnancy | Pregnancy, Planned

Type de données

boolean

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

Study Subject Participation Status | Treatment Arm Included

Type de données

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.
Description

Life Expectancy

Type de données

boolean

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

Valsalva Maneuver Airway pressure Perform Unable

Type de données

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.
Description

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

Type de données

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
Retour au début de la page

Similar models

Eligibility Heart Failure NCT00811551

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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