Aortic Stenosis, Heart Valve Prosthesis, Hemodynamics
Conditions
Keywords
Aortic Stenosis, Heart Valve Prosthesis, Hemodynamics, Sutureless, Standard aortic valve prosthesis
Brief summary
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
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
Interventions
DEVICESutureless aortic bioprosthesis
Patients will receive a sutureless aortic bioprosthesis
DEVICEConventional stented sutured aortic prosthesis
Patients will receive a stented sutured aortic prosthesis
Sponsors
Hospital San Carlos, Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Block randomisation 1:1 of conventional Vs sutureless aortic bioprostheses.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in mid term trans prosthetic gradients | 6 month | The differences in mid term trans prosthetic gradients measured by trans thoracic echocardiogram 6 months after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival from Combined major adverse cardiovascular event | 6 month | 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) |
| Differences in quality if life according to the KCCQ12 questionnaire | 6 month | 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 |
Countries
Spain
Contacts
Primary ContactManuel Carnero, MD, PhD
Outcome results
None listed