Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement
NCT ID: NCT03965065
Last Updated: 2020-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
350 participants
INTERVENTIONAL
2019-06-02
2020-05-30
Brief Summary
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* 6 -month hemodynamic performance.
* 6 month clinical outcomes including all cause mortality, stroke, myocardial infarction, valve reoperation and major/life threatening bleeding
* Cost effectiveness
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sutureless Aortic Valve Prosthesis
Patients receiving sutureless aortic valve prostheses
Sutureless aortic bioprosthesis
Patients will receive a sutureless aortic bioprosthesis
Conventional Aortic Valve Prosthesis
Patients receiving conventional biological aortic prostheses
Conventional stented sutured aortic prosthesis
Patients will receive a stented sutured aortic prosthesis
Interventions
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Sutureless aortic bioprosthesis
Patients will receive a sutureless aortic bioprosthesis
Conventional stented sutured aortic prosthesis
Patients will receive a stented sutured aortic prosthesis
Eligibility Criteria
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Inclusion Criteria
* Pure aortic stenosis or combined aortic stenosis/regurgitation
* Aortic annulus \>18 mm and \< 27 mm
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Hospital San Carlos, Madrid
OTHER
Responsible Party
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Manuel Carnero Alcazar
Adult Cardiac Surgeon, MD, PhD
Principal Investigators
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Manuel Carnero, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinico San Carlos. Madrid. Spain
Locations
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Hospital Clínico San Carlos
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19/153-R_P
Identifier Type: -
Identifier Source: org_study_id
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