ID

23176

Description

Responsible Party: Institut für Pharmakologie und Präventive Medizin ClinicalTrials.gov Identifier: NCT01991444 History of Changes Other Study ID Numbers: U1111-1149-9951 DRKS00005436 ( Other Identifier: Deutsches Register für Klinische Studien ) Study First Received: November 7, 2013 Last Updated: April 4, 2017 CGA-TAVI Registry to Evaluate the Predictive Value of a CGA in Predicting TAVI Outcomes (CGA-TAVI) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01991444

Link

https://clinicaltrials.gov/ct2/show/NCT01991444

Keywords

Versions (1)
  1. 6/26/17 6/26/17 -
Uploaded on

June 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Aortic Valve Stenosis NCT01991444 DRKS00005436

English

Eligibility Aortic Valve Stenosis NCT01991444 DRKS00005436

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Scheduled TAVI using Edwards SAPIEN XT Transcatheter Heart Valve
Description

TAVI

Data type

boolean

Alias
UMLS CUI [1]
C3702416
Compliance with the indications of the instructions for use
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Age of at least 80 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
Presence of contraindications as to the Instructions for Use
Description

Contraindication

Data type

boolean

Alias
UMLS CUI [1]
C1301624
No possibility for a follow-up
Description

Follow-Up

Data type

boolean

Alias
UMLS CUI [1]
C1522577
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Similar models

Eligibility Aortic Valve Stenosis NCT01991444 DRKS00005436

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
TAVI
Item
Scheduled TAVI using Edwards SAPIEN XT Transcatheter Heart Valve
boolean
C3702416 (UMLS CUI [1])
Compliance
Item
Compliance with the indications of the instructions for use
boolean
C1321605 (UMLS CUI [1])
Age
Item
Age of at least 80 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Contraindication
Item
Presence of contraindications as to the Instructions for Use
boolean
C1301624 (UMLS CUI [1])
Follow-Up
Item
No possibility for a follow-up
boolean
C1522577 (UMLS CUI [1])
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