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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03453567
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : June 23, 2021
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study evaluated effectiveness and safety of aortic valve replacement in real-world clinical practice.

Condition or disease Intervention/treatment
Aortic Valve Disease Aortic Valve Stenosis Procedure: Valve Replacement

Study Design
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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Effectiveness and Safety of Aortic Valve Replacement in Routine Clinical Practice; A Multicenter, Prospective Observational Study
Actual Study Start Date : May 10, 2018
Estimated Primary Completion Date : June 15, 2023
Estimated Study Completion Date : December 15, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. All-cause death [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with aortic valve replacement
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453567


Contacts
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Contact: Seung-jung Park, MD sjpark@amc.seoul.kr
Contact: Jung-hee Ham, RN +82230104728 cvcrc5@amc.seoul.kr

Locations
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Korea, Republic of
Sejong Hospital Recruiting
Bucheon, Korea, Republic of
Contact: Hee-moon Lee, MD       rhythmists@gmail.com   
Principal Investigator: Hee-moon Lee, MD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-jung Park, MD       sjpark@amc.seoul.kr   
Principal Investigator: Seung-jung Park, MD         
Pusan National University Yangsan Hospital Recruiting
Yangsan, Korea, Republic of
Contact: Hyoung-gon Je, MD       jehg7332@gmail.com   
Principal Investigator: Hyoung-gon Je, MD         
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
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Principal Investigator: Suk-Jung Choo, MD Asan Medical Center
More Information
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Responsible Party: Seung-Jung Park, Professor, Division of Cardiology, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03453567    
Other Study ID Numbers: AMCCV2018-04
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seung-Jung Park, Asan Medical Center:
TAVR
SAVR
TAVI
Conventional AVR
Sutureless AVR
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction