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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

515 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-09

Study Completion Date

2020-01-23

Brief Summary

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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

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Detailed Description

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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

Conditions

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Symptomatic Aortic Stenosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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TAVR

Percutaneous aortic valve replacement

Intervention Type PROCEDURE

Other Intervention Names

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Trans-aortic Valve Replacement

Eligibility Criteria

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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.

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No