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

February 19, 2020 updated by: Manuel Carnero Alcazar, Hospital San Carlos, Madrid

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 month
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
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Carlos, Madrid

Investigators

  • Principal Investigator: Manuel Carnero, MD, PhD, Hospital Clinico San Carlos. Madrid. Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 2, 2019

Primary Completion (ANTICIPATED)

May 30, 2020

Study Completion (ANTICIPATED)

May 30, 2020

Study Registration Dates

First Submitted

May 22, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (ACTUAL)

May 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/153-R_P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aortic Stenosis

Clinical Trials on Sutureless aortic bioprosthesis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe