Geriatric Assessment and Outcome in Patients Undergoing Transcatheter Aortic Valve Replacement

January 27, 2021 updated by: Sebastian Barth, Campus Bad Neustadt
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").

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Bad Neustadt an der Saale, Bavaria, Germany, 97616
        • Cardiovascular Center Bad Neustadt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all-comers cohort

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Live score in the "Minnesota living with heart failure questionnaire"
Time Frame: 6 month
self reported quality of life
6 month
frailty score
Time Frame: 6 month
multimodal geriatric assessment including cognitive Status (MMST, clock test, Tinetti test, stand up and go-test)
6 month
mortality after TAVI
Time Frame: 6 month
phone call follow-up
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bad Neustadt

Collaborators

Rhönklinikum AG

Investigators

  • Principal Investigator: Sebastian Barth, MD, Cardiovascular Center Bad Neustadt
  • Principal Investigator: Karsten Hamm, MD, Cardiovascular Center Bad Neustadt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2017

Primary Completion (Actual)

March 15, 2019

Study Completion (Actual)

September 15, 2020

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

May 31, 2017

First Posted (Actual)

June 1, 2017

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • CampusBN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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