Brief Title
Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement
Official Title
Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement: a Randomised Multicenter Study (Madrid, Spain)
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
Study Type
Interventional
Primary Outcome
Differences in mid term trans prosthetic gradients
Secondary Outcome
Survival from Combined major adverse cardiovascular event
Condition
Heart Valve Prosthesis
Intervention
Sutureless aortic bioprosthesis
Study Arms / Comparison Groups
Sutureless Aortic Valve Prosthesis
Description: Patients receiving sutureless aortic valve prostheses
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
350
Start Date
June 2, 2019
Completion Date
May 30, 2020
Primary Completion Date
May 30, 2020
Eligibility Criteria
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
Gender
All
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Manuel Carnero, MD, PhD, +34913303000, [email protected]
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT03965065
Organization ID
19/153-R_P
Responsible Party
Principal Investigator
Study Sponsor
Hospital San Carlos, Madrid
Study Sponsor
Manuel Carnero, MD, PhD, Principal Investigator, Hospital Clinico San Carlos. Madrid. Spain
Verification Date
February 2020