Evaluation of Effectiveness and Safety of Aortic Valve Replacement in Routine Clinical Practice (IRIS AVR)

December 28, 2025 updated by: Seung-Jung Park

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • South Korea
      • Bucheon-si, South Korea
        • Sejong Hospital
      • Seoul, South Korea
        • Asan Medical Center
      • Yangsan, South Korea
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with aortic valve replacement

Description

Inclusion Criteria:

  • Age 19 and more
  • Patient with aortic valve replacement

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
TAVR
Transcatheter Aortic Valve Replacement
Procedure: Valve Replacement
Aortic valve replacement
Sutureless AVR
Sutureless Aortic Valve Replacement
Procedure: Valve Replacement
Aortic valve replacement
Conventional AVR
Conventional Aortic Valve Replacement
Procedure: Valve Replacement
Aortic valve replacement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
All-cause death
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiovascular mortality
Time Frame: 5 years

A. 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
5 years
Myocardial infarction
Time Frame: 5 years

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

1-,6-, and 12-months, and 3-,5-years
5 years
All stroke and transient ischemic attack
Time Frame: 5 years

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

1-,6-, and 12-months, and 3-,5-years
5 years
Bleeding
Time Frame: 5 years

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

1-,6-, and 12-months, and 3-,5-years
5 years
Access site complication
Time Frame: 5 years

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
5 years
Acute kidney injury
Time Frame: 5 years

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

1-,6-, and 12-months, and 3-,5-years
5 years
Permanent pacemaker insertion
Time Frame: 5 years

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

1-,6-, and 12-months, and 3-,5-years
5 years
TAVR-related complication
Time Frame: 5 years

A. 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
5 years
Prosthetic valve dysfunction
Time Frame: 5 years

A. 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
5 years
Composite event
Time Frame: 5 years

A. 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
5 years
Structural valve deterioration
Time Frame: 5 years

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

1-,6-, and 12-months, and 3-,5-years
5 years
NYHA class
Time Frame: 30 days and 1 year
New York Heart Association (NYHA) Functional Classification
30 days and 1 year
The change of valve area
Time Frame: 30 days and 1 year
Aortic valve area measured by echocardiography (mm2)
30 days and 1 year
New onset atrial fibrillation
Time Frame: 30 days and 1 year
30 days and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seung-Jung Park

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CardioVascular Research Foundation, Korea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Suk-Jung Choo, MD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AMCCV2018-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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