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

Sponsor
Seung-Jung Park (Other)
Overall Status
Recruiting
CT.gov ID
NCT03453567
Collaborator
CardioVascular Research Foundation, Korea (Other)
900
Enrollment
3
Locations
115.2
Anticipated Duration (Months)
300
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Valve Replacement

Study Design

Study Type:
Observational
Anticipated 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
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Dec 15, 2027

Arms and Interventions

ArmIntervention/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

Primary Outcome Measures

  1. All-cause death [1 year]

Secondary Outcome Measures

  1. Cardiovascular mortality [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 [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 [5 years]

    Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years

  4. Bleeding [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 [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 [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 [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 [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 [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 [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 [5 years]

    Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years

  12. NYHA class [30 days and 1 year]

    New York Heart Association (NYHA) Functional Classification

  13. The change of valve area [30 days and 1 year]

    Aortic valve area measured by echocardiography (mm2)

  14. New onset atrial fibrillation [30 days and 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1Sejong HospitalBucheonKorea, Republic of
2Asan Medical CenterSeoulKorea, Republic of
3Pusan National University Yangsan HospitalYangsanKorea, Republic of

Sponsors and Collaborators

  • Seung-Jung Park
  • CardioVascular Research Foundation, Korea

Investigators

  • Principal Investigator: Suk-Jung Choo, MD, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seung-Jung Park, Professor, Division of Cardiology, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT03453567
Other Study ID Numbers:
  • AMCCV2018-04
First Posted:
Mar 5, 2018
Last Update Posted:
Jun 23, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seung-Jung Park, Professor, Division of Cardiology, Asan Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2021