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OpenTrials
Completed

NCT Number: NCT02424370

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

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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Key information

Conditions

Symptomatic Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Frailty Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Outflow Obstruction

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de Cardiologie-GH Pitié Salpétirère

Paris, Île-de-France Region, 75013, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAVR

Procedure

Percutaneous aortic valve replacement

Other names: Trans-aortic Valve Replacement

Primary outcomes

  1. Maintaining or improving the level of functional independence, defined as a score of Barthel index at 6 months

    Time frame: at 6 months

Secondary outcomes

  1. Score of Barthel

    Time frame: at 6, 9 and 12 months

    Maintaining of the same Score

  2. Maintain or improve the quality of life score at 6 months, defined as a score of SF-12 scale at 6 months

    Time frame: at 6 months

  3. Survival rate at 6 months, 9 months, 12 months

    Time frame: at 6, 9 and 12 months

  4. Survival time after TAVI during the study

    Time frame: up to 30 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: EVA-G-TAVI

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Apr 23, 2015
Registry last updated
Oct 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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