Burden Comorbidities and Transcatheter Aortic Valve Implantation

NCT ID: NCT01761357

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-12-31

Brief Summary

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The aim of the study is to determine whether the burden of comorbidities measured by CIRS-G (Cumulative Illness Rate Scale) is associated with a non-amelioration of the health related quality of life measured by questionnaire called "SF-36", six months after a transcatheter aortic valve replacement in older patients. During the comprehensive geriatric assessment realized before the valve implantation, the following data are recorded and their impact of the health related quality of life will also be analysed: comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.

Detailed Description

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Conditions

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Symptomatic Severe Aortic Valve Stenosis in Older Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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answering to questionnaires of quality of live

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients aged 75 years and older
* Patients referred for a transcatheter aortic valve implantation
* Patients who have a comprehensive geriatric assessment realized during the three months before the valve implantation
* Patients who provide informed written consent

Exclusion Criteria

* Patients who refuse the study
* Patients with a legal guardian
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Angers Universitary Hospital

Angers, , France

Site Status

Nantes Universitary Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC12_0387

Identifier Type: -

Identifier Source: org_study_id

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