Brief Title
CGA-TAVI Registry to Evaluate the Predictive Value of a CGA in Predicting TAVI Outcomes
Official Title
Registry Study to Evaluate the Predictive Value of a Comprehensive Geriatric Assessment With Regard to the Outcome of a Transcatheter Aortic Valve Implantation.
Brief Summary
Registry study to evaluate the predictive value of a comprehensive geriatric assessment with regard to the outcome of a transcatheter aortic valve Implantation. 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
Detailed Description
Transcatheter Aortic Valve Implantation Registry with Comprehensive Geriatric Assessment
Study Type
Observational [Patient Registry]
Primary Outcome
Comprehensive geriatric assessment
Secondary Outcome
predictive Value of CGA Tavi
Condition
Aortic Valve Stenosis
Intervention
TAVI
Study Arms / Comparison Groups
TAVI patients of > 79 years
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
72
Start Date
February 2014
Completion Date
February 2017
Primary Completion Date
December 2016
Eligibility Criteria
Inclusion Criteria: - Scheduled TAVI using Edwards SAPIEN XT Transcatheter Heart Valve - Compliance with the indications of the instructions for use - Age of at least 80 years - Written informed consent Exclusion Criteria: - Presence of contraindications as to the Instructions for Use - No possibility for a follow-up
Gender
All
Ages
80 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Andrea Ungar, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01991444
Organization ID
U1111-1149-9951
Secondary IDs
DRKS00005436
Responsible Party
Sponsor
Study Sponsor
Institut für Pharmakologie und Präventive Medizin
Study Sponsor
Andrea Ungar, MD, Principal Investigator, Geriatric Cardiology and Medicine - U. of Florence
Verification Date
April 2017