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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sutureless Aortic Valve Prosthesis | Experimental | Patients receiving sutureless aortic valve prostheses |
|
| Conventional Aortic Valve Prosthesis | Active Comparator | Patients receiving conventional biological aortic prostheses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sutureless aortic bioprosthesis | Device | Patients will receive a sutureless aortic bioprosthesis |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel Carnero, MD, PhD | Contact | +34913303000 | 3691 | manuel.carnero@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Manuel Carnero, MD, PhD | Hospital Clinico San Carlos. Madrid. Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico San Carlos | Recruiting | Madrid | 28222 | Spain |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Block randomisation 1:1 of conventional Vs sutureless aortic bioprostheses.
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| Conventional stented sutured aortic prosthesis | Device | Patients will receive a stented sutured aortic prosthesis |
|
| 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 |
| D014694 |
| Ventricular Outflow Obstruction |