CGA-TAVI Registry to Evaluate the Predictive Value of a CGA in Predicting TAVI Outcomes
NCT ID: NCT01991444
Last Updated: 2017-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
72 participants
OBSERVATIONAL
2014-02-28
2017-02-28
Brief Summary
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It will be evaluated which parts of the comprehensive geriatric assessment (CGA) are best suited to predict the therapeutic success of a heart valve Implantation in elderly ( \> 80 years) Patient. Possible participants are all Patient of 80 years or above for whom the implantation of a Edwards Sapien XT aortic valve is planned
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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TAVI patients of > 79 years
All patients undergoing transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve in participating sites.
Routine data about the intervention (transcatheter valve Implantation) will be collected. In addition, data describing the geriatric status of the patient, including a patient questionnaire evaluating his/her Quality of life will be collected.
TAVI
no Intervention planned, Observation only
Interventions
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TAVI
no Intervention planned, Observation only
Eligibility Criteria
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Inclusion Criteria
* Compliance with the indications of the instructions for use
* Age of at least 80 years
* Written informed consent
Exclusion Criteria
* No possibility for a follow-up
80 Years
ALL
No
Sponsors
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Institut für Pharmakologie und Präventive Medizin
NETWORK
Responsible Party
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Principal Investigators
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Andrea Ungar, MD
Role: PRINCIPAL_INVESTIGATOR
Geriatric Cardiology and Medicine - U. of Florence
Locations
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CRCHUM Montréal
Montreal, , Canada
University Medical Center
Florence, , Italy
Academisch Medisch Center
Amsterdam, , Netherlands
Countries
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References
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Ungar A, Mannarino G, van der Velde N, Baan J, Thibodeau MP, Masson JB, Santoro G, van Mourik M, Jansen S, Deutsch C, Bramlage P, Kurucova J, Thoenes M, Maggi S, Schoenenberger AW. Comprehensive geriatric assessment in patients undergoing transcatheter aortic valve implantation - results from the CGA-TAVI multicentre registry. BMC Cardiovasc Disord. 2018 Jan 4;18(1):1. doi: 10.1186/s12872-017-0740-x.
Other Identifiers
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DRKS00005436
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1149-9951
Identifier Type: -
Identifier Source: org_study_id
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