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

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Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation. CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System SMT Embolic Deflection CE Mark Trial DEFLECT I Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight Nitinol Circular Blade Functional Assessment In TAVI: FAITAVI CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. 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Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis Evaluation of BAV in Different Hemodynamic Entities of Severe AS Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic Severe Aortic Stenosis Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Rehabilitation in Aortic Stenosis Patients Aortic Stenosis 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PCSK9 Inhibitors in the Progression of Aortic Stenosis Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis. 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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