NCT02424370

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 515 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Symptomatic Aortic Stenosis

Interventions

Type	Name	Description
PROCEDURE	TAVR	Percutaneous aortic valve replacement

Timeline

• Start date: 2015-12-09
• Primary completion: 2018-09-18
• Completion: 2020-01-23
• First posted: 2015-04-23
• Last updated: 2020-10-12

Locations

1 site across 1 country: France