CGA-TAVI Registry to Evaluate the Predictive Value of a CGA in Predicting TAVI Outcomes

NCT ID: NCT01991444

Last Updated: 2017-04-05

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

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-02-28

Brief Summary

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Registry study to evaluate the predictive value of a comprehensive geriatric assessment with regard to the outcome of a transcatheter aortic valve Implantation.

It will be evaluated which parts of the comprehensive geriatric assessment (CGA) are best suited to predict the therapeutic success of a heart valve Implantation in elderly ( \> 80 years) Patient. Possible participants are all Patient of 80 years or above for whom the implantation of a Edwards Sapien XT aortic valve is planned

Detailed Description

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Transcatheter Aortic Valve Implantation Registry with Comprehensive Geriatric Assessment

Conditions

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Aortic Valve Stenosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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TAVI patients of > 79 years

All patients undergoing transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve in participating sites.

Routine data about the intervention (transcatheter valve Implantation) will be collected. In addition, data describing the geriatric status of the patient, including a patient questionnaire evaluating his/her Quality of life will be collected.

TAVI

Intervention Type OTHER

no Intervention planned, Observation only

Interventions

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TAVI

no Intervention planned, Observation only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Scheduled TAVI using Edwards SAPIEN XT Transcatheter Heart Valve
* Compliance with the indications of the instructions for use
* Age of at least 80 years
* Written informed consent

Exclusion Criteria

* Presence of contraindications as to the Instructions for Use
* No possibility for a follow-up
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut für Pharmakologie und Präventive Medizin

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Ungar, MD

Role: PRINCIPAL_INVESTIGATOR

Geriatric Cardiology and Medicine - U. of Florence

Locations

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CRCHUM Montréal

Montreal, , Canada

Site Status

University Medical Center

Florence, , Italy

Site Status

Academisch Medisch Center

Amsterdam, , Netherlands

Site Status

Countries

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Canada Italy Netherlands

References

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Ungar A, Mannarino G, van der Velde N, Baan J, Thibodeau MP, Masson JB, Santoro G, van Mourik M, Jansen S, Deutsch C, Bramlage P, Kurucova J, Thoenes M, Maggi S, Schoenenberger AW. Comprehensive geriatric assessment in patients undergoing transcatheter aortic valve implantation - results from the CGA-TAVI multicentre registry. BMC Cardiovasc Disord. 2018 Jan 4;18(1):1. doi: 10.1186/s12872-017-0740-x.

Reference Type DERIVED
PMID: 29301486 (View on PubMed)

Other Identifiers

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DRKS00005436

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1149-9951

Identifier Type: -

Identifier Source: org_study_id

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