ID

20258

Beschrijving

PreFER Managed Ventricular Pacing (MVP) For Elective Replacement; ODM derived from: https://clinicaltrials.gov/show/NCT00293241

Link

https://clinicaltrials.gov/show/NCT00293241

Trefwoorden

  1. 16-02-17 16-02-17 -
Geüploaded op

16 februari 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Cardiovascular Diseases NCT00293241

Eligibility Cardiovascular Diseases NCT00293241

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients implanted with a dual chamber device (including atrial synchronous ventricular inhibited [vdd]) for a minimum time duration of 2 years
Beschrijving

Dual chamber device

Datatype

boolean

Alias
UMLS CUI [1]
C2911683
planned to be replaced or replaced with a device including the mvp feature
Beschrijving

Replacement

Datatype

boolean

Alias
UMLS CUI [1]
C0559956
have had more than 40% ventricular pacing documented with their old device over a period of at least 4 weeks before enrollment or device replacement.
Beschrijving

Ventricular pacing

Datatype

boolean

Alias
UMLS CUI [1]
C2016308
pacing should not be caused by a switch to the single chamber pacing (vvi) mode because of battery depletion
Beschrijving

Battery depletion

Datatype

boolean

Alias
UMLS CUI [1]
C3532650
have signed the informed consent
Beschrijving

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
have no need to change the pacing mode or the atrioventricular (av) intervals.
Beschrijving

Changing the pacing mode or the atrioventricular intervals

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C0199640
UMLS CUI [2,1]
C0392747
UMLS CUI [2,2]
C2016228
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with a cardiac resynchronization therapy (crt) indication
Beschrijving

Cardiac resynchronization therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1167956
permanent af
Beschrijving

Atrial fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C0004238
permanent av block
Beschrijving

AV block

Datatype

boolean

Alias
UMLS CUI [1]
C0004245
inability to complete follow-up visits at a study center.
Beschrijving

Follow-up visit

Datatype

boolean

Alias
UMLS CUI [1]
C0589121
unwillingness or inability to cooperate or give written informed consent, or the patient is a minor, and legal guardian refuses to give informed consent
Beschrijving

Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
planned cardiovascular intervention
Beschrijving

Cardiovascular intervention

Datatype

boolean

Alias
UMLS CUI [1]
C0038897
inclusion in another clinical trial that will affect the objectives of this study
Beschrijving

Study Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
neurocardiogenic syncope as primary implantable pulse generator (ipg) indication.
Beschrijving

Neurocardiogenic syncope

Datatype

boolean

Alias
UMLS CUI [1]
C0042420

Similar models

Eligibility Cardiovascular Diseases NCT00293241

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Dual chamber device
Item
patients implanted with a dual chamber device (including atrial synchronous ventricular inhibited [vdd]) for a minimum time duration of 2 years
boolean
C2911683 (UMLS CUI [1])
Replacement
Item
planned to be replaced or replaced with a device including the mvp feature
boolean
C0559956 (UMLS CUI [1])
Ventricular pacing
Item
have had more than 40% ventricular pacing documented with their old device over a period of at least 4 weeks before enrollment or device replacement.
boolean
C2016308 (UMLS CUI [1])
Battery depletion
Item
pacing should not be caused by a switch to the single chamber pacing (vvi) mode because of battery depletion
boolean
C3532650 (UMLS CUI [1])
Informed consent
Item
have signed the informed consent
boolean
C0021430 (UMLS CUI [1])
Changing the pacing mode or the atrioventricular intervals
Item
have no need to change the pacing mode or the atrioventricular (av) intervals.
boolean
C0392747 (UMLS CUI [1,1])
C0199640 (UMLS CUI [1,2])
C0392747 (UMLS CUI [2,1])
C2016228 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Cardiac resynchronization therapy
Item
patients with a cardiac resynchronization therapy (crt) indication
boolean
C1167956 (UMLS CUI [1])
Atrial fibrillation
Item
permanent af
boolean
C0004238 (UMLS CUI [1])
AV block
Item
permanent av block
boolean
C0004245 (UMLS CUI [1])
Follow-up visit
Item
inability to complete follow-up visits at a study center.
boolean
C0589121 (UMLS CUI [1])
Compliance
Item
unwillingness or inability to cooperate or give written informed consent, or the patient is a minor, and legal guardian refuses to give informed consent
boolean
C1321605 (UMLS CUI [1])
Cardiovascular intervention
Item
planned cardiovascular intervention
boolean
C0038897 (UMLS CUI [1])
Study Participation Status
Item
inclusion in another clinical trial that will affect the objectives of this study
boolean
C2348568 (UMLS CUI [1])
Neurocardiogenic syncope
Item
neurocardiogenic syncope as primary implantable pulse generator (ipg) indication.
boolean
C0042420 (UMLS CUI [1])

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