Registry Study to Evaluate the Predictive Value of a Comprehensive Geriatric Assessment With Regard to the Outcome of a Transcatheter Aortic Valve Implantation.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
- Enrollment
- 72
- Locations
- 3
- Primary Endpoint
- Comprehensive geriatric assessment
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Score development(after 3 months)
- predictive Value of CGA Tavi(baseline)