Clinical trial NCT03965065: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Valve Prosthesis
Aortic Stenosis
Hemodynamics
Keywords: Aortic Stenosis
Heart Valve Prosthesis
Hemodynamics
Sutureless
Standard aortic valve prosthesis
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block randomisation 1:1 of conventional Vs sutureless aortic bioprostheses.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Differences in mid term trans prosthetic gradients
timeFrame: 6 month
Secondary outcomes:
measure: Survival from Combined major adverse cardiovascular event
timeFrame: 6 month
measure: Differences in quality if life according to the KCCQ12 questionnaire
timeFrame: 6 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
affiliation: Hospital Clinico San Carlos. Madrid. Spain
name: Manuel Carnero, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: