Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement

Overview

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

Full Title of Study: “Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement: a Randomised Multicenter Study (Madrid, Spain)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 30, 2020

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

  • Device: Sutureless aortic bioprosthesis
    • Patients will receive a sutureless aortic bioprosthesis
  • Device: Conventional stented sutured aortic prosthesis
    • Patients will receive a stented sutured aortic prosthesis

Arms, Groups and Cohorts

  • Experimental: Sutureless Aortic Valve Prosthesis
    • Patients receiving sutureless aortic valve prostheses
  • Active Comparator: Conventional Aortic Valve Prosthesis
    • Patients receiving conventional biological aortic prostheses

Clinical Trial Outcome Measures

Primary Measures

  • Differences in mid term trans prosthetic gradients
    • Time Frame: 6 month
    • The differences in mid term trans prosthetic gradients measured by trans thoracic echocardiogram 6 months after the procedure

Secondary Measures

  • Survival from Combined major adverse cardiovascular event
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital San Carlos, Madrid
  • Provider of Information About this Clinical Study
    • Principal Investigator: Manuel Carnero Alcazar, Adult Cardiac Surgeon, MD, PhD – Hospital San Carlos, Madrid
  • Overall Official(s)
    • Manuel Carnero, MD, PhD, Principal Investigator, Hospital Clinico San Carlos. Madrid. Spain
  • Overall Contact(s)
    • Manuel Carnero, MD, PhD, +34913303000, manuel.carnero@salud.madrid.org

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