Aortic Valve ReplacementNCT06782620

Association Between Surgical Aortic Valve Replacement and Long-term Outcomes in 50 to 65-year-olds

An observational study of Aortic Valve Replacement, run by Medical University of Vienna at 1 site in Austria.

Completed

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

Trial summary

The goal of this observational study o is to compare outcomes after either biological or mechanical aortic valve replacement. The main question it aims to answer: Is survival better after mechanical aortic valve replacement compared to biological aortic valve replacement? Are there less complications and reoperations… Read more about this study

Who is it for?: Ages 50 to 65 years
Conditions the study is for: Aortic Valve Replacement
How many people: 3,761 participants
Where: 1 siteAustria
Study dates: 1 Jan 2020to 31 Dec 2024
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 50 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: * age between 50 and 65 years * st. p. isolated biological or mechanical aortic valve replacement

Who may be able to join

age between 50 and 65 years
st. p. isolated biological or mechanical aortic valve replacement

Who cannot join

transcatheter aortic valve implantation (TAVI; MEL codes DB025, DB026, DB021, or XN010) as index procedure
age <50 or >65 years
concomitant heart surgery or additional procedures during the index operation
patients receiving a coronary artery stent (MEL codes DD050 or DD060) within four months before AVR

Trial locations and contacts

1 site in 1 country.

Austria1 site

Medical University of Vienna
Vienna, State of Vienna, 1090

Other trials in Austria

About this study

Official title: Association Between Surgical Aortic Valve Replacement and Long-term Outcomes in 50 to 65-year-olds: Results of the AUTHEARTVISIT Study

The goal of this observational study o is to compare outcomes after either biological or mechanical aortic valve replacement. The main question it aims to answer:

Is survival better after mechanical aortic valve replacement compared to biological aortic valve replacement? Are there less complications and reoperations after mechanical aortic valve replacement compared to biological aortic valve replacement? We perform a retrospective Data Collection of anonymized Austrian health insurance data.

Read the detailed description

Objectives: In recent years, age recommendations for the utilization of biological prostheses rather than mechanical prostheses for surgical aortic valve replacement (sAVR) have been significantly reduced. This study evaluated survival rates, major adverse cardiac events (MACEs), and reoperation risks following surgical (sM-AVR) and biological (sB-AVR) AVR, with the aim of providing data to inform optimal prosthesis selection for middle-aged patients between 50 and 65 years.

Methods: A population-based cohort study was conducted using data from the Austrian Health System from 2010 to 2020. Patients undergoing isolated sAVR (n=3761) were categorized into sM-AVR (n=1018) and sB-AVR (n=2743) groups. Propensity score matching (PSM) was applied to balance covariates. The primary endpoint was all-cause mortality. The secondary endpoints included MACEs, reoperation, stroke, bleeding, and post-reoperation survival. Outcomes were assessed using Cox regression and Kaplan-Meier analyses.

Conditions: Aortic Valve Replacement
Keywords: aortic valve replacement, mechanical AVR, biological AVR

What participants receive

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

Study groups in NCT06782620
Study group	Role	What they receive
sB-AVR		Patients with biological Aortic valve replacement
sM-AVR		Patients with mechanical Aortic valve replacement

What is being measured

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

Survival
overall Survival
Measured: up to 12 years

Secondary outcomes (7)

reoperation-free survival
reoperation-free survival after either biological or mechanical AVR
Measured: up to 12 years
reoperation
reoperation after either biological or mechanical AVR
Measured: up to 12 years
MACEs
MACEs after either biological or mechanical AVR
Measured: up to 12 years
heart failure
heart failure after either biological or mechanical AVR
Measured: up to 12 years
embolic stroke or ICH
embolic stroke or ICH after either biological or mechanical AVR
Measured: up to 12 years
myocardial infarction
myocardial infarction after either biological or mechanical AVR
Measured: up to 12 years
non-embolic bleeding
non-embolic bleeding after either biological or mechanical AVR
Measured: up to 12 years

Timeline

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

1 Jan 202031 Dec 2024

First posted20 Jan 2025
Study start1 Jan 2020
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Aortic Valve ReplacementStudies 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: Case-control
Time perspective: Retrospective
Enrolment: 3,761 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06782620
Sponsor's protocol ID: GS1-EK-4/722-2021
Status last verified: Jan 2025
First submitted: 13 Jan 2025
Last updated: 20 Jan 2025
Results posted: No
Data monitoring committee: No
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?

See locations

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
Active, not recruiting
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
Aortic Valve Stenosis
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
Active, not recruiting
JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases

All Aortic Valve Replacement trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Association Between Surgical Aortic Valve Replacement and Long-term Outcomes in 50 to 65-year-olds: Results of the AUTHEARTVISIT Study
ClinicalTrials.gov ID: NCT06782620
Acronym / sponsor ID: GS1-EK-4/722-2021
Conditions: Aortic Valve Replacement
Keywords: aortic valve replacement, mechanical AVR, biological AVR
Study type: Observational
Recruitment status: Completed
Enrolment: 3,761 participants (actual)
Lead sponsor: Medical University of ViennaUniversity, hospital or other
Study start: 1 Jan 2020 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 20 Jan 2025 (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.

The goal of this observational study o is to compare outcomes after either biological or mechanical aortic valve replacement. The main question it aims to answer:

Detailed description

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
sB-AVR	–	–Patients with biological Aortic valve replacement
sM-AVR	–	–Patients with mechanical Aortic valve replacement

Who may qualify

Ages: 50 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: * age between 50 and 65 years * st. p. isolated biological or mechanical aortic valve replacement

Key inclusion criteria (2 listed)

age between 50 and 65 years
st. p. isolated biological or mechanical aortic valve replacement

Key exclusion criteria (4 listed)

transcatheter aortic valve implantation (TAVI; MEL codes DB025, DB026, DB021, or XN010) as index procedure
age <50 or >65 years
concomitant heart surgery or additional procedures during the index operation
patients receiving a coronary artery stent (MEL codes DD050 or DD060) within four months before AVR

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Survival
Time frame: up to 12 years
overall Survival

7 secondary outcomes

reoperation-free survival
Time frame: up to 12 years
reoperation
Time frame: up to 12 years
MACEs
Time frame: up to 12 years
heart failure
Time frame: up to 12 years
embolic stroke or ICH
Time frame: up to 12 years
myocardial infarction
Time frame: up to 12 years
non-embolic bleeding
Time frame: up to 12 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 20 Jan 2025.
Individual participant dataSharing planned: No

Related trials for Aortic Valve Replacement

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
Active, not recruiting
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
Aortic Valve Stenosis
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
Active, not recruiting
JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases

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.

Hendrik J Ankersmit, Univ. Prof. Dr. principal investigator

Medical University of Vienna

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 Aortic Valve Replacement, run by Medical University of Vienna at 1 site in Austria.

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 2 inclusion and 4 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 20 Jan 2025. 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 Austria. 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?

Survival (time frame: up to 12 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 NCT06782620.

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 20 Jan 2025.