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OpenTrials
Completed

NCT Number: NCT03173079

Geriatric Assessment and Outcome in Patients Undergoing Transcatheter Aortic Valve Replacement

A geriatric assessment is becoming increasingly important in the treatment of patients with a percutaneous aortic valve replacement due to their comorbidities. The aim of this multimodal therapy concept is to examine the influence on the postoperative outcome. In addition to a comprehensive assessment of the individual frailty score, the subjective condition before and after TAVI is also evaluated using a standardized questionnaire ("Minnesota living with heart failure questionnaire").

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Key information

Conditions

Influence of Geriatric Functional State on the Outcome After TAVI Possible Change in Geriatric Assessment After TAVI

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiovascular Center Bad Neustadt

Bad Neustadt an der Saale, Bavaria, 97616, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • all patients with indication for TAVI according to the current guidelines

Exclusion criteria

  • no indication for TAVI, indication for cardiac surgery, mentally disabled patients, patients with endocarditis or life expectancy of less than 2 years

Treatment and study plan

pre- and postinterventional geriatric assessment in patients undergoing TAVI

Other

geriatric assessment

Primary outcomes

  1. Quality of Live score in the "Minnesota living with heart failure questionnaire"

    Time frame: 6 month

    self reported quality of life

  2. frailty score

    Time frame: 6 month

    multimodal geriatric assessment including cognitive Status (MMST, clock test, Tinetti test, stand up and go-test)

  3. mortality after TAVI

    Time frame: 6 month

    phone call follow-up

Sponsors and collaborators

Lead sponsor

Campus Bad Neustadt

Other

Collaborators

  • Rhönklinikum AG

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jun 1, 2017
Registry last updated
Feb 1, 2021

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.