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

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: Recruiting
• Conditions: Aortic Valve Stenosis; Aortic Valve Disease
• Intervention / Treatment: Procedure: Valve Replacement

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Jung-hee Ham, RN; Phone Number: +82230104728; Email: cvcrc5@amc.seoul.kr
• Study Contact Backup: Name: Seung-jung Park, MD; Email: sjpark@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Recruiting
    • Sejong Hospital
    • Contact: Hee-moon Lee, MD; Email: rhythmists@gmail.com
    • Principal Investigator: Hee-moon Lee, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Seung-jung Park, MD; Email: sjpark@amc.seoul.kr
    • Principal Investigator: Seung-jung Park, MD
  • Yangsan, Korea, Republic of
    • Recruiting
    • Pusan National University Yangsan Hospital
    • Contact: Hyoung-gon Je, MD; Email: jehg7332@gmail.com
    • Principal Investigator: Hyoung-gon Je, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause death	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular mortality	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	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	Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years	5 years
Bleeding	Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years	5 years
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	5 years
Acute kidney injury	Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years	5 years
Permanent pacemaker insertion	Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years	5 years
TAVR-related complication	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	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	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	Either Discharge or 30-day, at the earliest time point 1-,6-, and 12-months, and 3-,5-years	5 years
NYHA class	New York Heart Association (NYHA) Functional Classification	30 days and 1 year
The change of valve area	Aortic valve area measured by echocardiography (mm2)	30 days and 1 year
New onset atrial fibrillation		30 days and 1 year

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea
• Investigators: Principal Investigator: Suk-Jung Choo, MD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2018
• Primary Completion (Estimated): June 15, 2030
• Study Completion (Estimated): December 15, 2030

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: TAVI; TAVR; SAVR; Conventional AVR; Sutureless AVR
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Disease
• Other Study ID 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