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Completed

NCT Number: NCT01991444

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

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

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CRCHUM Montréal, Montreal, Canada

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About this study

Transcatheter Aortic Valve Implantation Registry with Comprehensive Geriatric Assessment

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAVI

Other

no Intervention planned, Observation only

Primary outcomes

  1. Comprehensive geriatric assessment

    Time frame: Baseline and 3 months

    Demonstrate CGA changes within 3 months after TAVI

    The CGA is an array of several different assessments with regard to frailty, comorbidities, administrative data (Silver code), Quality of life etc. Every Patient will undergo a CGA at baseline and 3 months after TAVI. Data will be analyzed to determine changes in CGA results.

Secondary outcomes

  1. predictive Value of CGA Tavi

    Time frame: baseline

    Establish predictive value of CGA (MPI, SPPB, SilverCode) in TAVI patients for all-cause hospitalization, TAVI related hospitalization, nursing home admission

  2. Score development

    Time frame: after 3 months

    Development of a comprehensive score for the assessment of TAVI patient prognosis (identifying variables from the MPI, SPPB and SilverCode that account for 80% of the predictive power of the complete set)

Sponsors and collaborators

Lead sponsor

Institut für Pharmakologie und Präventive Medizin

Network

Registry information

Official study title

Registry Study to Evaluate the Predictive Value of a Comprehensive Geriatric Assessment With Regard to the Outcome of a Transcatheter Aortic Valve Implantation.

Acronym: CGA-TAVI

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Nov 25, 2013
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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