Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation (EVA-G-TAVI)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Symptomatic Aortic Stenosis

Treatments: Procedure: TAVR

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02424370

NI11069

Details and patient eligibility

About

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

Full 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

Enrollment: 515 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Exclusion criteria: