CGA-TAVI Registry to Evaluate the Predictive Value of a CGA in Predicting TAVI Outcomes

N/ACompletedNCT01991444

Institut für Pharmakologie und Präventive Medizin72 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aortic Valve Stenosis

Interventions

TAVIOTHER

no Intervention planned, Observation only

Eligibility

Sex: ALLMin age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

CRCHUM Montréal

Montreal, Canada

University Medical Center

Florence, Italy

Academisch Medisch Center

Amsterdam, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 3 months

Secondary Outcomes

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

Time frame: baseline

Score development

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)

Time frame: after 3 months

Data from ClinicalTrials.gov

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