Aortic Valve DiseaseNCT05627973

Health Status of < 50 Year Old Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2020)

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 either mechanical valves or bioprostheses by retrieving data from the main social security carriers in Austria for the years 2010-2020 in under 50 year old patients. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Aortic Valve Disease
What is being tested?: Aortic Valve Replacement
Type of treatment: Medical device
How many people: 991 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 18 to 50 years
All sexes
No healthy volunteers
Adult

Study population: All patients who underwent isolated surgical aortic valve replacement in Austria above 18 years and below 50 years of age with no other concomitant heart surgery were included.

Who may be able to join

isolated surgical aortic valve replacement in Austria

Who cannot join

below 18 years of age
above 50 years of age
concomitant heart surgery

About this study

Read the detailed description

The purpose of this research project is to evaluate mortality (primary outcome) and incidence of heart attack, stroke, reoperation and first diagnosis of heart insufficiency, MACE (secondary outcomes) after aortic valve replacement in under 50 year olds. We aim to compare those outcomes between mechanical valves and bioprostheses.

Data will be retrieved from the main social security carriers in Austria (covering 98% of its population) from 2010-2020.

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
Surgical replacement of aortic valves

Study groups in NCT05627973
Study group	Role	What they receive
Aortic valve replacement with mechanical valves		Not described Receives: Device: Aortic Valve Replacement
Aortic valve replacement with bioprostheses		Not described Receives: Device: Aortic Valve Replacement

What is being measured

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

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

Secondary outcomes (5)

reoperation
incidence of reoperation after aortic valve replacement
Measured: 10 years
stroke
incidence of stroke after aortic valve replacement
Measured: 10 years
heart attack
incidence of heart attack after aortic valve replacement
Measured: 10 years
heart insufficiency
incidence of heart insufficiency after aortic valve replacement
Measured: 10 years
MACE
incidence of MACE 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 posted28 Nov 2022
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: 991 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05627973
Sponsor's protocol ID: AUTHEARTVISIT < 50
Status last verified: Nov 2022
First submitted: 16 Nov 2022
Last updated: 28 Nov 2022
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 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Health Status of < 50 Year Old Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2020)
ClinicalTrials.gov ID: NCT05627973
Acronym / sponsor ID: AUTHEARTVISIT < 50
Conditions: Aortic Valve Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 991 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: 28 Nov 2022 (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.

Detailed description

Data will be retrieved from the main social security carriers in Austria (covering 98% of its population) from 2010-2020.

Study design

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

Arm	Type	Receives
Aortic valve replacement with mechanical valves	–	Device: Aortic Valve Replacement
Aortic valve replacement with bioprostheses	–	Device: Aortic Valve Replacement

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult
Study population: All patients who underwent isolated surgical aortic valve replacement in Austria above 18 years and below 50 years of age with no other concomitant heart surgery were included.

Key inclusion criteria (1 listed)

isolated surgical aortic valve replacement in Austria

Key exclusion criteria (3 listed)

below 18 years of age
above 50 years of age
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 ReplacementSurgical replacement of aortic valves	Device	Aortic valve replacement with bioprostheses, Aortic valve replacement with mechanical valves

Primary outcome

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

5 secondary outcomes

reoperation
Time frame: 10 years
stroke
Time frame: 10 years
heart attack
Time frame: 10 years
heart insufficiency
Time frame: 10 years
MACE
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 28 Nov 2022.
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 28 Nov 2022. 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?

Overall 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 NCT05627973.

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 28 Nov 2022.