ID

20832

Beschreibung

RAPID-RF: Remote Active Monitoring in Patients With Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00334451

Link

https://clinicaltrials.gov/show/NCT00334451

Stichworte

Versionen (2)
  1. 21.03.17 21.03.17 -
  2. 17.09.21 17.09.21 -
Hochgeladen am

21. März 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00334451

Englisch

Eligibility Heart Failure NCT00334451

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients who meet current indications for a guidant rf-enabled crt-d device (e.g. contak renewal 3 rf family of crt-d devices) which is compatible with the latitude communicator. indications include: nyha class iii, iv; ef of ≤ 35%; qrs duration of
Beschreibung

Indication Cardiac Resynchronization Therapy Defibrillator (CRT-D) Radiofrequency ablation | New York Heart Association Classification | Ejection fraction | QRS complex duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1736558
UMLS CUI [1,3]
C0850292
UMLS CUI [2]
C1275491
UMLS CUI [3]
C2700378
UMLS CUI [4]
C0429025
≥ 120 ms; and optimized pharmacologic therapy
Beschreibung

Pharmacotherapy Optimal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C2698651
patients who have an analog telephone line compatible with the latitude communicator. the latitude communicator must be placed within 8 feet of where they sleep for successful remote interrogations to occur.
Beschreibung

Access to telephone Compatible with Clinical Trial Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1822200
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0449432
patients who receive the study components including the latitude communicator, weight scale, and blood pressure monitor
Beschreibung

Clinical Trial Components | Scale weight | Blood Pressure Monitor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449432
UMLS CUI [2]
C3878937
UMLS CUI [3]
C1622509
patients who are willing and capable of providing informed consent prior to implant and willing to participate in the rapid-rf registry
Beschreibung

Informed Consent | Participation Registry Radiofrequency ablation Rapid

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0034975
UMLS CUI [2,3]
C0850292
UMLS CUI [2,4]
C0456962
patients who remain in the clinical care of a rapid-rf investigator at approved centers
Beschreibung

Patient care Clinical Investigator Radiofrequency ablation Rapid

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017313
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0850292
UMLS CUI [1,4]
C0456962
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are expected to receive a heart transplant during the course of the study
Beschreibung

Heart Transplantation Expected

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C1517001
patients who have received or who will receive a tricuspid valve prosthesis during the course of the study
Beschreibung

Tricuspid valve prosthesis

Datentyp

boolean

Alias
UMLS CUI [1]
C3839627
patients who have previously received an implantable cardiac resynchronization device (e.g., biventricular pacemaker or biventricular icd)
Beschreibung

Cardiac Resynchronization Therapy Device | Biventricular Pacemaker | Implantable defibrillator biventricular

Datentyp

boolean

Alias
UMLS CUI [1]
C2936377
UMLS CUI [2]
C1719274
UMLS CUI [3,1]
C0162589
UMLS CUI [3,2]
C0699808
patients whose life expectancy is less than 12 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
patients who are currently enrolled in another observational registry or investigational study that could directly impact the treatment or outcome of the rapid-rf registry. contact guidant's clinical application research study (cars) department to determine eligibility.
Beschreibung

Study Subject Participation Status Impact Therapeutic procedure | Study Subject Participation Status Impact Research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C4049986
UMLS CUI [2,3]
C0683954
patients who are younger than 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
patients who are pregnant or plan to become pregnant during the study
Beschreibung

Pregnancy | Pregnancy, Planned

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
patients who are unable or refuse to comply with the protocol requirements
Beschreibung

Protocol Compliance Unable | Protocol Compliance Refused

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1705116
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Ähnliche Modelle

Eligibility Heart Failure NCT00334451

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Indication Cardiac Resynchronization Therapy Defibrillator (CRT-D) Radiofrequency ablation | New York Heart Association Classification | Ejection fraction | QRS complex duration
Item
patients who meet current indications for a guidant rf-enabled crt-d device (e.g. contak renewal 3 rf family of crt-d devices) which is compatible with the latitude communicator. indications include: nyha class iii, iv; ef of ≤ 35%; qrs duration of
boolean
C3146298 (UMLS CUI [1,1])
C1736558 (UMLS CUI [1,2])
C0850292 (UMLS CUI [1,3])
C1275491 (UMLS CUI [2])
C2700378 (UMLS CUI [3])
C0429025 (UMLS CUI [4])
Pharmacotherapy Optimal
Item
≥ 120 ms; and optimized pharmacologic therapy
boolean
C0013216 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
Access to telephone Compatible with Clinical Trial Component
Item
patients who have an analog telephone line compatible with the latitude communicator. the latitude communicator must be placed within 8 feet of where they sleep for successful remote interrogations to occur.
boolean
C1822200 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0449432 (UMLS CUI [1,4])
Clinical Trial Components | Scale weight | Blood Pressure Monitor
Item
patients who receive the study components including the latitude communicator, weight scale, and blood pressure monitor
boolean
C0008976 (UMLS CUI [1,1])
C0449432 (UMLS CUI [1,2])
C3878937 (UMLS CUI [2])
C1622509 (UMLS CUI [3])
Informed Consent | Participation Registry Radiofrequency ablation Rapid
Item
patients who are willing and capable of providing informed consent prior to implant and willing to participate in the rapid-rf registry
boolean
C0021430 (UMLS CUI [1])
C0679823 (UMLS CUI [2,1])
C0034975 (UMLS CUI [2,2])
C0850292 (UMLS CUI [2,3])
C0456962 (UMLS CUI [2,4])
Patient care Clinical Investigator Radiofrequency ablation Rapid
Item
patients who remain in the clinical care of a rapid-rf investigator at approved centers
boolean
C0017313 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0850292 (UMLS CUI [1,3])
C0456962 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Heart Transplantation Expected
Item
patients who are expected to receive a heart transplant during the course of the study
boolean
C0018823 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Tricuspid valve prosthesis
Item
patients who have received or who will receive a tricuspid valve prosthesis during the course of the study
boolean
C3839627 (UMLS CUI [1])
Cardiac Resynchronization Therapy Device | Biventricular Pacemaker | Implantable defibrillator biventricular
Item
patients who have previously received an implantable cardiac resynchronization device (e.g., biventricular pacemaker or biventricular icd)
boolean
C2936377 (UMLS CUI [1])
C1719274 (UMLS CUI [2])
C0162589 (UMLS CUI [3,1])
C0699808 (UMLS CUI [3,2])
Life Expectancy
Item
patients whose life expectancy is less than 12 months
boolean
C0023671 (UMLS CUI [1])
Study Subject Participation Status Impact Therapeutic procedure | Study Subject Participation Status Impact Research results
Item
patients who are currently enrolled in another observational registry or investigational study that could directly impact the treatment or outcome of the rapid-rf registry. contact guidant's clinical application research study (cars) department to determine eligibility.
boolean
C2348568 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C4049986 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
Age
Item
patients who are younger than 18 years of age
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
patients who are pregnant or plan to become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Protocol Compliance Unable | Protocol Compliance Refused
Item
patients who are unable or refuse to comply with the protocol requirements
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
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