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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS00005436 | Other Identifier | Deutsches Register fĂ¼r Klinische Studien |
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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
Transcatheter Aortic Valve Implantation Registry with Comprehensive Geriatric Assessment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVI | Other | no Intervention planned, Observation only |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comprehensive geriatric assessment | 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. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| predictive Value of CGA Tavi | Establish predictive value of CGA (MPI, SPPB, SilverCode) in TAVI patients for all-cause hospitalization, TAVI related hospitalization, nursing home admission | baseline |
| Score development |
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Inclusion Criteria:
Exclusion Criteria:
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All patients undergoing transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve in participating sites.
Routine data about the invervention (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.
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Ungar, MD | Geriatric Cardiology and Medicine - U. of Florence | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRCHUM Montréal | Montreal | H2X 0A9 | Canada | |||
| University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29301486 | Derived | 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. |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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)
| after 3 months |
| Florence |
| Italy |
| Academisch Medisch Center | Amsterdam | Netherlands |
| D014694 |
| Ventricular Outflow Obstruction |