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

Symptomatic Aortic Stenosis Clinical Trial

— EVA-G-TAVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424370
• Other study ID #: NI11069
• Status: Completed
• Start date: December 9, 2015
• Est. completion date: January 23, 2020

Study information

• Verified date: March 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: January 23, 2020
• Est. primary completion date: September 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Symptomatic Aortic Stenosis

Intervention

Procedure:
• TAVR
Percutaneous aortic valve replacement

Locations

Country	Name	City	State
France	Institut de Cardiologie-GH Pitié Salpétirère	Paris	Ile De France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Medtronic

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintaining or improving the level of functional independence, defined as a score of Barthel index at 6 months		at 6 months
Secondary	Score of Barthel	Maintaining of the same Score	at 6, 9 and 12 months
Secondary	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
Secondary	Survival rate at 6 months, 9 months, 12 months		at 6, 9 and 12 months
Secondary	Survival time after TAVI during the study		up to 30 months