Aortic Valve DiseaseNCT05912660

Health Status of Patients After Surgically Implanted Biological and TAVI: a Population-based Retrospective Analysis

An observational study of Aortic Valve Disease, run by Medical University of Vienna.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The overall project aim is to study outcomes following aortic valve replacement with surgically implanted bioprostheses or TAVI by retrieving data from the main social security carriers in Austria for the years 2010-2020. Read more about this study

Who is it for?: Ages 65 to 99 years
Conditions the study is for: Aortic Valve Disease
What is being tested?: Aortic Valve Replacement
Type of treatment: Medical device
How many people: 18,882 participants
Where: No sites listed yet
Study dates: 1 Jan 2010to 31 Dec 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 65 to 99 years
All sexes
No healthy volunteers
Older adult

Study population: All patients who underwent isolated aortic valve replacement in Austria (surgically implanted bioprostheses or TAVI) above 65 years of age with no other concomitant heart surgery and no coronary revascularization within 4 months before the index procedure were included.

Who may be able to join

isolated aortic valve replacement in Austria (surgically implanted bioprostheses or TAVI)

Who cannot join

below 65 years of age
coronary revascularization within 4 months before the index procedure
concomitant heart surgery

About this study

Conditions: Aortic Valve Disease
Being tested: Aortic Valve Replacement
Medical subject headings: Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aortic Valve ReplacementDevice
Aortic Valve Replacement (surgically or TAVI)

Study groups in NCT05912660
Study group	Role	What they receive
Aortic valve replacement with surgically implanted bioprostheses		Not described Receives: Device: Aortic Valve Replacement
Aortic valve replacement with TAVI		Not described Receives: Device: Aortic Valve Replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

all-cause mortality
all cause mortality after aortic valve replacement
Measured: 10 years

Secondary outcomes (4)

reoperation
incidence of reoperation after aortic valve replacement
Measured: 10 years
myocardial infaction
incidence of myocardial infaction after aortic valve replacement
Measured: 10 years
heart failure
incidence of heart failure after aortic valve replacement
Measured: 10 years
stroke
incidence of stroke after aortic valve replacement
Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201031 Dec 2020

First posted22 Jun 2023
Study start1 Jan 2010
Primary completion31 Dec 2020
Study completion31 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
More trials run by Medical University of ViennaThe sponsor's other registered studies.
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: Other
Time perspective: Retrospective
Enrolment: 18,882 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05912660
Sponsor's protocol ID: AUTHEARTVISIT - TAVI
Status last verified: Jun 2023
First submitted: 10 Jun 2023
Last updated: 22 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Valve Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Health Status of Patients After Surgically Implanted Biological and TAVI: a Population-based Retrospective Analysis
ClinicalTrials.gov ID: NCT05912660
Acronym / sponsor ID: AUTHEARTVISIT - TAVI
Conditions: Aortic Valve Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 18,882 participants (actual)
Lead sponsor: Medical University of ViennaUniversity, hospital or other
Collaborators: Sicknessfund Burgenland, Landesklinikum Sankt Polten
Study start: 1 Jan 2010 (actual)
Primary completion: 31 Dec 2020 (actual)
Study completion: 31 Dec 2020 (actual)
First posted: 22 Jun 2023 (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.

Study design

Observational model: Other
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Aortic valve replacement with surgically implanted bioprostheses	–	Device: Aortic Valve Replacement
Aortic valve replacement with TAVI	–	Device: Aortic Valve Replacement

Who may qualify

Ages: 65 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
Study population: All patients who underwent isolated aortic valve replacement in Austria (surgically implanted bioprostheses or TAVI) above 65 years of age with no other concomitant heart surgery and no coronary revascularization within 4 months before the index procedure were included.

Key inclusion criteria (1 listed)

isolated aortic valve replacement in Austria (surgically implanted bioprostheses or TAVI)

Key exclusion criteria (3 listed)

below 65 years of age
coronary revascularization within 4 months before the index procedure
concomitant heart surgery

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
Aortic Valve ReplacementAortic Valve Replacement (surgically or TAVI)	Device	Aortic valve replacement with TAVI, Aortic valve replacement with surgically implanted bioprostheses

Primary outcome

all-cause mortality
Time frame: 10 years
all cause mortality after aortic valve replacement

4 secondary outcomes

reoperation
Time frame: 10 years
myocardial infaction
Time frame: 10 years
heart failure
Time frame: 10 years
stroke
Time frame: 10 years

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 22 Jun 2023.
Individual participant dataSharing planned: No

Related trials for Aortic Valve Disease

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Disease, run by Medical University of Vienna.

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 3 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

all-cause mortality (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05912660.

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 22 Jun 2023.