Geriatric Assessment and Outcome in Patients Undergoing Transcatheter Aortic Valve Replacement

Influence of Geriatric Functional State on the Outcome After TAVI Clinical Trial

Official title:

Geriatric Assessment and Outcome in Patients Undergoing Transcatheter Aortic Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03173079
• Other study ID #: CampusBN
• Status: Completed
• Start date: March 15, 2017
• Est. completion date: September 15, 2020

Study information

• Verified date: January 2021
• Source: Campus Bad Neustadt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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").

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 15, 2020
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• pre- and postinterventional geriatric assessment in patients undergoing TAVI
geriatric assessment

Locations

Country	Name	City	State
Germany	Cardiovascular Center Bad Neustadt	Bad Neustadt an der Saale	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Campus Bad Neustadt	Rhönklinikum AG

Country where clinical trial is conducted

Germany, 

Outcome

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