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

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

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

Conditions
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Aortic Valve Disease, Aortic Valve Stenosis

Intervention / Treatment
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* Procedure: Valve Replacement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAVR<br>Transcatheter Aortic Valve Replacement | Procedure: Valve Replacement<br>* Aortic valve replacement<br>|
| Sutureless AVR<br>Sutureless Aortic Valve Replacement | Procedure: Valve Replacement<br>* Aortic valve replacement<br>|
| Conventional AVR<br>Conventional Aortic Valve Replacement | Procedure: Valve Replacement<br>* Aortic valve replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVR, SAVR, TAVI, Conventional AVR, Sutureless AVR