Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation

Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation. Multicenter Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02424370

Acronym

EVA-G-TAVI

Enrollment

515

Registered

2015-04-23

Start date

2015-12-09

Completion date

2020-01-23

Last updated

2020-10-12

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

Conditions

Symptomatic Aortic Stenosis

Keywords

Aortic stenosis, TAVR, Frailty, Elderly

Brief summary

Transcutaneous trans-aortic valve replacement (TAVR) is now a common procedure to treat symptomatic aortic stenosis. Although as effective and safe as surgical aortic valve replacement, it is still restricted to high surgical risk patient who are frail. The aim of the TAVI-EVA is to identify geriatric biomarkers that may help to predict survival and functional recovery after TAVR

Detailed description

Primary objective: identify geriatric biomarkers associated with vital/functional status after TAVR. Primary outcome measure is altered functional status at six month follow-up defined as an absolute decrease of 15 points of the Barthel Index. Secondary outcome measures are: Barthel index and survival at 6, 9 and 12 months follow-up. QOL during follow-up

Interventions

PROCEDURETAVR

Percutaneous aortic valve replacement

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

75 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥75 * Symptomatic aortic stenosis * Prior geriatric evaluation * Patient who agreed to answer the telephone follow-up to 6, 9 and 12 months * Patient given his non-opposition to using his data * Patient affiliated to the French social security.

Design outcomes

Primary

Measure	Time frame
Maintaining or improving the level of functional independence, defined as a score of Barthel index at 6 months	at 6 months

Secondary

Measure	Time frame	Description
Survival rate at 6 months, 9 months, 12 months	at 6, 9 and 12 months	—
Survival time after TAVI during the study	up to 30 months	—
Score of Barthel	at 6, 9 and 12 months	Maintaining of the same Score
Maintain or improve the quality of life score at 6 months, defined as a score of SF-12 scale at 6 months	at 6 months	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026