NCT02424370

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
515

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

December 9, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2020

Completed
Last Updated

October 12, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

April 20, 2015

Last Update Submit

October 9, 2020

Conditions

Symptomatic Aortic Stenosis

Keywords

Aortic stenosisTAVRFrailtyElderly

Outcome Measures

Primary Outcomes (1)

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

    at 6 months

Secondary Outcomes (4)

  • Score of Barthel

    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

    at 6 months

  • 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

Interventions

TAVRPROCEDURE

Percutaneous aortic valve replacement

Also known as: Trans-aortic Valve Replacement

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

person aged over 75 years with indication for implantation of TAVI

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cardiologie-GH Pitié Salpétirère

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

Location

MeSH Terms

Conditions

Aortic Valve StenosisFrailty

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joël BELMIN, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Jean Philippe COLLET, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 23, 2015

Study Start

December 9, 2015

Primary Completion

September 18, 2018

Study Completion

January 23, 2020

Last Updated

October 12, 2020

Record last verified: 2020-03

Locations

FR(1)