Influence of Geriatric Functional State on the Outcome After TAVINCT03173079
Geriatric Assessment and Outcome in Patients Undergoing Transcatheter Aortic Valve Replacement
An observational study of Influence of Geriatric Functional State on the Outcome After TAVI and Possible Change in Geriatric Assessment After TAVI, run by Campus Bad Neustadt at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Influence of Geriatric Functional State on the Outcome After TAVI, Possible Change in Geriatric Assessment After TAVI
- What is being tested?
- pre- and postinterventional geriatric assessment in patients undergoing TAVI
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2017to 15 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: all-comers cohort
Who may be able to join
- all patients with indication for TAVI according to the current guidelines
Who cannot join
- no indication for TAVI, indication for cardiac surgery, mentally disabled patients, patients with endocarditis or life expectancy of less than 2 years
Trial locations and contacts
1 site in 1 country.
Germany1 site
Cardiovascular Center Bad Neustadt
Bad Neustadt an der Saale, Bavaria, 97616
About this study
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
- Influence of Geriatric Functional State on the Outcome After TAVI, Possible Change in Geriatric Assessment After TAVI
- Being tested
- pre- and postinterventional geriatric assessment in patients undergoing TAVI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre- and postinterventional geriatric assessment in patients undergoing TAVIOther
geriatric assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Live score in the "Minnesota living with heart failure questionnaire"
self reported quality of life
Measured: 6 month
frailty score
multimodal geriatric assessment including cognitive Status (MMST, clock test, Tinetti test, stand up and go-test)
Measured: 6 month
mortality after TAVI
phone call follow-up
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start15 Mar 2017
- Primary completion15 Mar 2019
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influence of Geriatric Functional State on the Outcome After TAVIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bad Neustadt
- Sponsor type
- University, hospital or other
- Collaborators
- Rhönklinikum AG
- Responsible party
- Principal investigator, Sebastian Barth, Campus Bad Neustadt
- Investigators
- Sebastian Barth, MD, Principal investigator, Cardiovascular Center Bad NeustadtKarsten Hamm, MD, Principal investigator, Cardiovascular Center Bad Neustadt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173079
- Sponsor's protocol ID
- CampusBN
- Status last verified
- Jan 2021
- First submitted
- 30 May 2017
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Assessment and Outcome in Patients Undergoing Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT03173079
- Acronym / sponsor ID
- CampusBN
- Conditions
- Influence of Geriatric Functional State on the Outcome After TAVI, Possible Change in Geriatric Assessment After TAVI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Campus Bad NeustadtUniversity, hospital or other
- Collaborators
- Rhönklinikum AG
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- all-comers cohort
Key inclusion criteria (1 listed)
- all patients with indication for TAVI according to the current guidelines
Key exclusion criteria (1 listed)
- no indication for TAVI, indication for cardiac surgery, mentally disabled patients, patients with endocarditis or life expectancy of less than 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre- and postinterventional geriatric assessment in patients undergoing TAVIgeriatric assessment | Other | – |
Primary outcome
Quality of Live score in the "Minnesota living with heart failure questionnaire"
Time frame: 6 month
self reported quality of life
frailty score
Time frame: 6 month
multimodal geriatric assessment including cognitive Status (MMST, clock test, Tinetti test, stand up and go-test)
mortality after TAVI
Time frame: 6 month
phone call follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Barth, MD principal investigator
Cardiovascular Center Bad Neustadt
Karsten Hamm, MD principal investigator
Cardiovascular Center Bad Neustadt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influence of Geriatric Functional State on the Outcome After TAVI and Possible Change in Geriatric Assessment After TAVI, run by Campus Bad Neustadt at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Live score in the "Minnesota living with heart failure questionnaire" (time frame: 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.