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

Aortic Valve Stenosis Clinical Trial

— IRIS AVR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03453567
• Other study ID #: AMCCV2018-04
• Status: Recruiting
• Start date: May 10, 2018
• Est. completion date: December 15, 2030

Study information

• Verified date: December 2023
• Source: Asan Medical Center
• Contact: Seung-jung Park, MD
• Email: sjpark[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 15, 2030
• Est. primary completion date: June 15, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Stenosis

Intervention

Procedure:
• Valve Replacement
Aortic valve replacement

Locations

Country	Name	City	State
Korea, Republic of	Sejong Hospital	Bucheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death		1 year
Secondary	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
Secondary	Myocardial infarction	Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years	5 years
Secondary	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
Secondary	Bleeding	Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years	5 years
Secondary	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
Secondary	Acute kidney injury	Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years	5 years
Secondary	Permanent pacemaker insertion	Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Structural valve deterioration	Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years	5 years
Secondary	NYHA class	New York Heart Association (NYHA) Functional Classification	30 days and 1 year
Secondary	The change of valve area	Aortic valve area measured by echocardiography (mm2)	30 days and 1 year
Secondary	New onset atrial fibrillation		30 days and 1 year