CGA-TAVI Registry to Evaluate the Predictive Value of a CGA in Predicting TAVI Outcomes (CGA-TAVI)
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|ClinicalTrials.gov Identifier: NCT01991444|
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : April 5, 2017
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
|Condition or disease||Intervention/treatment|
|Aortic Valve Stenosis||Other: TAVI|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||72 participants|
|Target Follow-Up Duration:||12 Months|
|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.|
|Actual Study Start Date :||February 2014|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||February 2017|
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.
no Intervention planned, Observation only
- Comprehensive geriatric assessment [ Time Frame: Baseline and 3 months ]
Demonstrate CGA changes within 3 months after TAVI
The CGA is an array of several different assessments with regard to frailty, comorbidities, administrative data (Silver code), Quality of life etc. Every Patient will undergo a CGA at baseline and 3 months after TAVI. Data will be analyzed to determine changes in CGA results.
- predictive Value of CGA Tavi [ Time Frame: baseline ]Establish predictive value of CGA (MPI, SPPB, SilverCode) in TAVI patients for all-cause hospitalization, TAVI related hospitalization, nursing home admission
- Score development [ Time Frame: after 3 months ]Development of a comprehensive score for the assessment of TAVI patient prognosis (identifying variables from the MPI, SPPB and SilverCode that account for 80% of the predictive power of the complete set)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991444
|Montreal, Canada, H2X 0A9|
|University Medical Center|
|Academisch Medisch Center|
|Principal Investigator:||Andrea Ungar, MD||Geriatric Cardiology and Medicine - U. of Florence|