ID

37594

Descripción

Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T; ODM derived from: https://clinicaltrials.gov/show/NCT01930695

Link

https://clinicaltrials.gov/show/NCT01930695

Palabras clave

Versiones (1)
  1. 9/8/19 9/8/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

9 de agosto de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01930695

Inglés

Eligibility Atrial Fibrillation NCT01930695

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
crt-d indication according to current esc guidelines (nyha iii/iv; qrs≥120ms; lvef≤35%; expected survival ≥ 1 year; need for pacing because of slow ventricular rate or pacemaker dependency as a result of av nodal ablation or ventricular rate
Descripción

Indication CRT-D | New York Heart Association Classification | QRS duration | Left ventricular ejection fraction | Life Expectancy | Patient need for Cardiac pacing | Ventricular Heart Rate Slow | Artificial cardiac pacemaker dependent Due to Ablation of Cardiac Atrioventricular Node | Artificial cardiac pacemaker dependent Due to Ventricular Heart Rate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2936377
UMLS CUI [2]
C1275491
UMLS CUI [3]
C0429025
UMLS CUI [4]
C0428772
UMLS CUI [5]
C0023671
UMLS CUI [6,1]
C0686904
UMLS CUI [6,2]
C0199640
UMLS CUI [7,1]
C1883530
UMLS CUI [7,2]
C0439834
UMLS CUI [8,1]
C0030163
UMLS CUI [8,2]
C3244310
UMLS CUI [8,3]
C0678226
UMLS CUI [8,4]
C3275044
UMLS CUI [9,1]
C0030163
UMLS CUI [9,2]
C3244310
UMLS CUI [9,3]
C0678226
UMLS CUI [9,4]
C1883530
≤60bpm at rest and ≤90bpm on exercise)
Descripción

Ventricular Heart Rate At rest | Ventricular Heart Rate Exercise

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1883530
UMLS CUI [1,2]
C0443144
UMLS CUI [2,1]
C1883530
UMLS CUI [2,2]
C0015259
permanent atrial fibrillation
Descripción

Permanent atrial fibrillation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2586056
patients planned to be implanted with biotronik lumax 640/740 hf-t
Descripción

Implantation ICD Specified Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021107
UMLS CUI [1,2]
C0162589
UMLS CUI [1,3]
C0205369
UMLS CUI [1,4]
C1301732
patients planned to be implanted with biotronik linoxsmart s dx right ventricular lead (or successors)
Descripción

Implantation ICD Specified Planned

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021107
UMLS CUI [1,2]
C0162589
UMLS CUI [1,3]
C0205369
UMLS CUI [1,4]
C1301732
patient eligible for programming of dx functionality according to the physicians`
Descripción

Patient Eligible ICD Specified

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0162589
UMLS CUI [1,4]
C0205369
decision
Descripción

Physician Decision

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1709536
patient is willing and able to comply with the cip and provided written informed consent
Descripción

Protocol Compliance | Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
patient accepts home monitoring® concept and has sufficient gsm/gprs coverage
Descripción

Agreement Monitoring At home

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C0030695
UMLS CUI [1,3]
C4534363
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with any contraindication to crt-d therapy
Descripción

Medical contraindication CRT-D

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2936377
patients listed for heart transplantation
Descripción

Patient on waiting list Heart Transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0422768
UMLS CUI [1,2]
C0018823
life expectancy less than 12 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
pregnant or breast-feeding women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients under the age of 18
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
patients with limited contractual capability
Descripción

Legal competency Limited

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0680554
UMLS CUI [1,2]
C0439801
participation in any other clinical study
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Atrial Fibrillation NCT01930695

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Indication CRT-D | New York Heart Association Classification | QRS duration | Left ventricular ejection fraction | Life Expectancy | Patient need for Cardiac pacing | Ventricular Heart Rate Slow | Artificial cardiac pacemaker dependent Due to Ablation of Cardiac Atrioventricular Node | Artificial cardiac pacemaker dependent Due to Ventricular Heart Rate
Item
crt-d indication according to current esc guidelines (nyha iii/iv; qrs≥120ms; lvef≤35%; expected survival ≥ 1 year; need for pacing because of slow ventricular rate or pacemaker dependency as a result of av nodal ablation or ventricular rate
boolean
C3146298 (UMLS CUI [1,1])
C2936377 (UMLS CUI [1,2])
C1275491 (UMLS CUI [2])
C0429025 (UMLS CUI [3])
C0428772 (UMLS CUI [4])
C0023671 (UMLS CUI [5])
C0686904 (UMLS CUI [6,1])
C0199640 (UMLS CUI [6,2])
C1883530 (UMLS CUI [7,1])
C0439834 (UMLS CUI [7,2])
C0030163 (UMLS CUI [8,1])
C3244310 (UMLS CUI [8,2])
C0678226 (UMLS CUI [8,3])
C3275044 (UMLS CUI [8,4])
C0030163 (UMLS CUI [9,1])
C3244310 (UMLS CUI [9,2])
C0678226 (UMLS CUI [9,3])
C1883530 (UMLS CUI [9,4])
Ventricular Heart Rate At rest | Ventricular Heart Rate Exercise
Item
≤60bpm at rest and ≤90bpm on exercise)
boolean
C1883530 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
C1883530 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
Permanent atrial fibrillation
Item
permanent atrial fibrillation
boolean
C2586056 (UMLS CUI [1])
Implantation ICD Specified Planned
Item
patients planned to be implanted with biotronik lumax 640/740 hf-t
boolean
C0021107 (UMLS CUI [1,1])
C0162589 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Implantation ICD Specified Planned
Item
patients planned to be implanted with biotronik linoxsmart s dx right ventricular lead (or successors)
boolean
C0021107 (UMLS CUI [1,1])
C0162589 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Patient Eligible ICD Specified
Item
patient eligible for programming of dx functionality according to the physicians`
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0162589 (UMLS CUI [1,3])
C0205369 (UMLS CUI [1,4])
Physician Decision
Item
decision
boolean
C1709536 (UMLS CUI [1])
Protocol Compliance | Informed Consent
Item
patient is willing and able to comply with the cip and provided written informed consent
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Agreement Monitoring At home
Item
patient accepts home monitoring® concept and has sufficient gsm/gprs coverage
boolean
C0680240 (UMLS CUI [1,1])
C0030695 (UMLS CUI [1,2])
C4534363 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Medical contraindication CRT-D
Item
patients with any contraindication to crt-d therapy
boolean
C1301624 (UMLS CUI [1,1])
C2936377 (UMLS CUI [1,2])
Patient on waiting list Heart Transplantation
Item
patients listed for heart transplantation
boolean
C0422768 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy less than 12 months
boolean
C0023671 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Age
Item
patients under the age of 18
boolean
C0001779 (UMLS CUI [1])
Legal competency Limited
Item
patients with limited contractual capability
boolean
C0680554 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Study Subject Participation Status
Item
participation in any other clinical study
boolean
C2348568 (UMLS CUI [1])
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