NCT03173079

Brief Summary

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").

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

May 30, 2017

Last Update Submit

January 27, 2021

Conditions

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

Outcome Measures

Primary Outcomes (3)

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

    self reported quality of life

    6 month

  • frailty score

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

    6 month

  • mortality after TAVI

    phone call follow-up

    6 month

Interventions

pre- and postinterventional geriatric assessment in patients undergoing TAVIOTHER

geriatric assessment

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all-comers cohort

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Center Bad Neustadt

Bad Neustadt an der Saale, Bavaria, 97616, Germany

Location

MeSH Terms

Interventions

Lead

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetals

Study Officials

  • Sebastian Barth, MD

    Cardiovascular Center Bad Neustadt

    PRINCIPAL INVESTIGATOR

  • Karsten Hamm, MD

    Cardiovascular Center Bad Neustadt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 1, 2017

Study Start

March 15, 2017

Primary Completion

March 15, 2019

Study Completion

September 15, 2020

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

DE(1)