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

October 9, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

515

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile De France
      • Paris, Ile De France, France, 75013
        • Institut de Cardiologie-GH Pitié Salpétirère

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

person aged over 75 years with indication for implantation of TAVI

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of Barthel
Time Frame: at 6, 9 and 12 months
Maintaining of the same Score
at 6, 9 and 12 months
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
at 6 months
Survival rate at 6 months, 9 months, 12 months
Time Frame: at 6, 9 and 12 months
at 6, 9 and 12 months
Survival time after TAVI during the study
Time Frame: up to 30 months
up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Medtronic

Investigators

  • Principal Investigator: Joël BELMIN, MD,PhD, Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Jean Philippe COLLET, MD,PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2015

Primary Completion (Actual)

September 18, 2018

Study Completion (Actual)

January 23, 2020

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimate)

April 23, 2015

Study Record Updates

Last Update Posted (Actual)

October 12, 2020

Last Update Submitted That Met QC Criteria

October 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI11069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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