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Aortic Valve DiseaseIRIS AVRNCT03453567

Evaluation of Effectiveness and Safety of Aortic Valve Replacement in Routine Clinical Practice

An observational study of Aortic Valve Disease and Aortic Valve Stenosis, run by Seung-Jung Park at 3 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study evaluated effectiveness and safety of aortic valve replacement in real-world clinical practice. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Aortic Valve Disease, Aortic Valve Stenosis
What is being tested?
Valve Replacement
Type of treatment
Surgery or procedure
How many people
900 participants
Where
3 sitesSouth Korea
Study dates
10 May 2018to 15 Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with aortic valve replacement

Who may be able to join

  • Age 19 and more
  • Patient with aortic valve replacement

Who cannot join

  • Combined with mitral stenosis requiring surgery or aorta stenosis
  • Acute bacterial endocarditis within 1 month of valve replacement

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Sejong Hospital

    Bucheon-si

  • Asan Medical Center

    Seoul

  • Pusan National University Yangsan Hospital

    Yangsan

Other trials in South Korea

About this study

Official title: Evaluation of Effectiveness and Safety of Aortic Valve Replacement in Routine Clinical Practice; A Multicenter, Prospective Observational Study

This study evaluated effectiveness and safety of aortic valve replacement in real-world clinical practice.

Being tested
Valve Replacement
Keywords
TAVR, SAVR, TAVI, Conventional AVR, Sutureless AVR
Medical subject headings
Aortic Valve Disease, Aortic Valve Stenosis

What participants receive

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

  • Valve ReplacementProcedure or surgery

    Aortic valve replacement

Study groups in NCT03453567
Study groupRoleWhat they receive
TAVRTranscatheter Aortic Valve Replacement
Receives: Procedure: Valve Replacement
Sutureless AVRSutureless Aortic Valve Replacement
Receives: Procedure: Valve Replacement
Conventional AVRConventional Aortic Valve Replacement
Receives: Procedure: Valve Replacement

What is being measured

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

  1. All-cause death

    Measured: 1 year

Secondary outcomes (14)

  1. Cardiovascular mortality

    1. Death due to proximate cardiac cause B. Death caused by noncoronary vascular condition C. All procedure-related/surgery-related death D. All valve-related death E. Sudden or unwitnessed death F. Death of unknown cause

    Either Discharge or 30-day, at the earliest time point

    1-,6-, and 12-months, and 3-,5-years

    Measured: 5 years

  2. Myocardial infarction

    Either Discharge or 30-day, at the earliest time point

    1-,6-, and 12-months, and 3-,5-years

    Measured: 5 years

  3. All stroke and transient ischemic attack

    Either Discharge or 30-day, at the earliest time point

    1-,6-, and 12-months, and 3-,5-years

    Measured: 5 years

  4. Bleeding

    Either Discharge or 30-day, at the earliest time point

    1-,6-, and 12-months, and 3-,5-years

    Measured: 5 years

  5. Access site complication

    Operation site complication Vascular access site and access-related complication

    Either Discharge or 30-day, at the earliest time point

    1-,6-, and 12-months, and 3-,5-years

    Measured: 5 years

  6. Acute kidney injury

    Either Discharge or 30-day, at the earliest time point

    1-,6-, and 12-months, and 3-,5-years

    Measured: 5 years

  7. Permanent pacemaker insertion

    Either Discharge or 30-day, at the earliest time point

    1-,6-, and 12-months, and 3-,5-years

    Measured: 5 years

  8. TAVR-related complication

    1. Conversion to open surgery B. Coronary obstruction C. Mitral valve apparatus damage or dysfunction D. Cardiac tamponade E. Endocarditis F. Valve thrombosis G. Valve malpositioning H. TAV-in-TAV deployment

    Either Discharge or 30-day, at the earliest time point

    1-,6-, and 12-months, and 3-,5-years

    Measured: 5 years

  9. Prosthetic valve dysfunction

    1. Prosthetic aortic valve stenosis B. Prosthesis-patient mismatch C. Prosthetic aortic valve regurgitation

    Either Discharge or 30-day, at the earliest time point

    1-,6-, and 12-months, and 3-,5-years

    Measured: 5 years

  10. Composite event

    1. Device success B. Early safety (30 days)
    • Death, stroke, life-threatening bleeding, acute kidney injury, coronary stenosis requiring intervention, significant vascular complication, valve dysfunction requiring intervention C. Clinical efficacy (30 days)
    • Death, stroke, deteriorating heart failure or valve function requiring hospitalization, NYHA III or IV dyspnea, valve dysfunction

    Either Discharge or 30-day, at the earliest time point

    1-,6-, and 12-months, and 3-,5-years

    Measured: 5 years

  11. Structural valve deterioration

    Either Discharge or 30-day, at the earliest time point

    1-,6-, and 12-months, and 3-,5-years

    Measured: 5 years

  12. NYHA class

    New York Heart Association (NYHA) Functional Classification

    Measured: 30 days and 1 year

  13. The change of valve area

    Aortic valve area measured by echocardiography (mm2)

    Measured: 30 days and 1 year

  14. New onset atrial fibrillation

    Measured: 30 days and 1 year

Timeline

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

  1. First posted5 Mar 2018
  2. Study start10 May 2018
  3. Primary completion15 Jun 2030 (estimated)
  4. Study completion15 Dec 2030 (estimated)

Resources

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
900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03453567
Sponsor's protocol ID
AMCCV2018-04
Acronym
IRIS AVR
Status last verified
Dec 2025
First submitted
27 Feb 2018
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Disease and Aortic Valve Stenosis, run by Seung-Jung Park at 3 sites in South Korea.

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 2 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: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. 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?

This study is still under way. Results are not available in the source record yet.

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 death (time frame: 1 year). 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 NCT03453567.

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 2 Jan 2026.

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