Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965065
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Manuel Carnero Alcazar, Hospital San Carlos, Madrid

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

Condition or disease Intervention/treatment Phase
Heart Valve Prosthesis Aortic Stenosis Hemodynamics Device: Sutureless aortic bioprosthesis Device: Conventional stented sutured aortic prosthesis Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Block randomisation 1:1 of conventional Vs sutureless aortic bioprostheses.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement: a Randomised Multicenter Study (Madrid, Spain)
Actual Study Start Date : June 2, 2019
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020


Arm Intervention/treatment
Experimental: Sutureless Aortic Valve Prosthesis
Patients receiving sutureless aortic valve prostheses
Device: Sutureless aortic bioprosthesis
Patients will receive a sutureless aortic bioprosthesis

Active Comparator: Conventional Aortic Valve Prosthesis
Patients receiving conventional biological aortic prostheses
Device: Conventional stented sutured aortic prosthesis
Patients will receive a stented sutured aortic prosthesis




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965065


Contacts
Layout table for location contacts
Contact: Manuel Carnero, MD, PhD +34913303000 ext 3691 manuel.carnero@salud.madrid.org

Locations
Layout table for location information
Spain
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28222
Contact: Manuel Carnero, MD, PhD    +34913303000 ext 3691    manuel.carnero@salud.madrid.org   
Sponsors and Collaborators
Hospital San Carlos, Madrid
Investigators
Layout table for investigator information
Principal Investigator: Manuel Carnero, MD, PhD Hospital Clinico San Carlos. Madrid. Spain
Layout table for additonal information
Responsible Party: Manuel Carnero Alcazar, Adult Cardiac Surgeon, MD, PhD, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT03965065    
Other Study ID Numbers: 19/153-R_P
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Manuel Carnero Alcazar, Hospital San Carlos, Madrid:
Aortic Stenosis
Heart Valve Prosthesis
Hemodynamics
Sutureless
Standard aortic valve prosthesis
Additional relevant MeSH terms:
Layout table for MeSH terms
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction