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NCT Number: NCT03453567

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sejong Hospital, Bucheon-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valve replacement

Procedure

Aortic valve replacement

Primary outcomes

  1. All-cause death

    Time frame: 1 year

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. NYHA class

    Time frame: 30 days and 1 year

    New York Heart Association (NYHA) Functional Classification

  13. The change of valve area

    Time frame: 30 days and 1 year

    Aortic valve area measured by echocardiography (mm2)

  14. New onset atrial fibrillation

    Time frame: 30 days and 1 year

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

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

Acronym: IRIS AVR

Important dates

Study start
2018
Primary completion
2030
Study completion
2030
First posted
Mar 5, 2018
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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