Geriatric Evaluation to Predict Mortality and Functional... | NCT02424370

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

NCT02424370

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Oct 12, 2020Actual

Enrollment

515Actual

Phase

Not provided

Conditions

Symptomatic Aortic Stenosis

Interventions

TAVR

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2015Actual

Primary Completion Date

Sep 18, 2018Actual

Completion Date

Jan 23, 2020Actual

First Submitted Date

Apr 20, 2015

First Submission Date that Met QC Criteria

Apr 22, 2015

First Posted Date

Apr 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2020

Last Update Posted Date

Oct 12, 2020Actual

Name	Class
Medtronic	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

515Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAVR	Procedure	Percutaneous aortic valve replacement		Trans-aortic Valve Replacement

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Score of Barthel	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		at 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

person aged over 75 years with indication for implantation of TAVI

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joël BELMIN, MD,PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator
Jean Philippe COLLET, MD,PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut de Cardiologie-GH Pitié Salpétirère		Paris	Île-de-France Region	75013	France

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis
D000073496	Frailty

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided