Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement

Study Overview
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Brief Summary
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Multicenter randomised study which aims to compare sutureless Vs. standard bio- prostheses (1:1) among patients undergoing surgical aortic valve replacement in terms of: 6 -month hemodynamic performance. 6 month clinical outcomes including all cause mortality, stroke, myocardial infarction, valve reoperation and major/life threatening bleeding Cost effectiveness

Detailed Description
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This study is aimed to compare clinical and hemodynamic performance of conventional sutured stented bio-prostheses among patients undergoing a surgical aortic valve replacement. The prostheses are not pre specified to be provided by a specific manufacturer, so that any bio prosthesis but transcatheter and scentless aortic valves can be implanted. The estimated sample size is 350 patients. They will be randomised 1:1 to any of the two arms of the study (standard Vs. sutureless prostheses). The randomisation will be stratified according to the need for a concomitant coronary artery bypass grafting procedure. Six hospitals in Madrid (Spain) will take part in the study. The period of recruitment will start as soon as June 2019 and is supposed to finish by June 2020 or earlier. The main outcomes of the study will be measured 6 months after the aortic valve implantation

Official Title
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Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement: a Randomised Multicenter Study (Madrid, Spain)

Conditions
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Heart Valve Prosthesis, Aortic Stenosis, Hemodynamics

Intervention / Treatment
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* Device: Sutureless aortic bioprosthesis
* Device: Conventional stented sutured aortic prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 Pure aortic stenosis or combined aortic stenosis/regurgitation Aortic annulus >18 mm and < 27 mm Exclusion Criteria: Pregnancy Willing to receive some other prosthesis Concomitant surgery of the ascending aorta or left ventricle outflow tract Endocarditis Emergency Some other concomitant procedure Participation in any other study Previous surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Block randomisation 1:1 of conventional Vs sutureless aortic bioprostheses.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sutureless Aortic Valve Prosthesis<br>Patients receiving sutureless aortic valve prostheses | Device: Sutureless aortic bioprosthesis<br>* Patients will receive a sutureless aortic bioprosthesis<br>|
| Active Comparator: Conventional Aortic Valve Prosthesis<br>Patients receiving conventional biological aortic prostheses | Device: Conventional stented sutured aortic prosthesis<br>* Patients will receive a stented sutured aortic prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in mid term trans prosthetic gradients | The differences in mid term trans prosthetic gradients measured by trans thoracic echocardiogram 6 months after the procedure | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival from Combined major adverse cardiovascular event | Comparison of survival free from a combined event including: all cause mortality, major stroke (mRS>1), Myocardial Infarction (according to VARC-II criteria), Valve re operation of any case, major or life-threatening bleeding (VARC 2 definition) | 6 month | 
| Differences in quality if life according to the KCCQ12 questionnaire | Quality of life will be compared between the two groups using the Kansas City Cardiomyopathy Questionnaire (KCCQ12). The response options of the items are Likert scales of 1 to 5, 6 or 7 points and the score has a theoretical range of 0 to 100, with 100 being the best | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Stenosis, Heart Valve Prosthesis, Hemodynamics, Sutureless, Standard aortic valve prosthesis