## Protocol Section
### Identification Module
**NCT ID:** NCT03173079

**Brief Title:** Geriatric Assessment and Outcome in Patients Undergoing Transcatheter Aortic Valve Replacement

**Official Title:** Geriatric Assessment and Outcome in Patients Undergoing Transcatheter Aortic Valve Replacement

#### Organization Study ID Info
**ID:** CampusBN
#### Organization
**Class:** OTHER
**Full Name:** Campus Bad Neustadt
### Status Module
#### Completion Date
**Date:** 2020-09-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-02-01

**Type:** ACTUAL

**Last Update Submit Date:** 2021-01-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-03-15

**Type:** ACTUAL

#### Start Date
**Date:** 2017-03-15

**Type:** ACTUAL

**Status Verified Date:** 2021-01

#### Study First Post Date
**Date:** 2017-06-01
**Type:** ACTUAL
**Study First Submit Date:** 2017-05-30
**Study First Submit QC Date:** 2017-05-31
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Rhönklinikum AG

#### Lead Sponsor

**Class:** OTHER

**Name:** Campus Bad Neustadt

#### Responsible Party

**Investigator Affiliation:** Campus Bad Neustadt

**Investigator Full Name:** Sebastian Barth

**Investigator Title:** PI

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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").

### Conditions Module

**Conditions:**

- Influence of Geriatric Functional State on the Outcome After TAVI

- Possible Change in Geriatric Assessment After TAVI

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 220

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** geriatric assessment

**Name:** pre- and postinterventional geriatric assessment in patients undergoing TAVI

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** self reported quality of life

**Measure:** Quality of Live score in the "Minnesota living with heart failure questionnaire"

**Time Frame:** 6 month

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

**Measure:** frailty score

**Time Frame:** 6 month

**Description:** phone call follow-up

**Measure:** mortality after TAVI

**Time Frame:** 6 month

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 70 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

**Study Population:** all-comers cohort

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bad Neustadt an der Saale

**Country:** Germany

**Facility:** Cardiovascular Center Bad Neustadt

**State:** Bavaria

**Zip:** 97616

#### Overall Officials

**Official 1:**

**Affiliation:** Cardiovascular Center Bad Neustadt

**Name:** Sebastian Barth, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Cardiovascular Center Bad Neustadt

**Name:** Karsten Hamm, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
