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

Registry Study to Evaluate the Predictive Value of a Comprehensive Geriatric Assessment With Regard to the Outcome of a Transcatheter Aortic Valve Implantation.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01991444

Acronym

CGA-TAVI

Enrollment

Registered

2013-11-25

Start date

2014-02-28

Completion date

2017-02-28

Last updated

2017-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

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

Interventions

OTHERTAVI

no Intervention planned, Observation only

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

80 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Comprehensive geriatric assessment	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

Measure	Time frame	Description
predictive Value of CGA Tavi	baseline	Establish predictive value of CGA (MPI, SPPB, SilverCode) in TAVI patients for all-cause hospitalization, TAVI related hospitalization, nursing home admission
Score development	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)

Countries

Canada, Italy, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026