Back to results

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

Primary Purpose

Heart Valve Prosthesis, Aortic Stenosis, Hemodynamics

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Sutureless aortic bioprosthesis

Conventional stented sutured aortic prosthesis

About this trial

This is an interventional treatment trial for Heart Valve Prosthesis focused on measuring Aortic Stenosis, Heart Valve Prosthesis, Hemodynamics, Sutureless, Standard aortic valve prosthesis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Clínico San CarlosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sutureless Aortic Valve Prosthesis

Conventional Aortic Valve Prosthesis

Arm Description

Patients receiving sutureless aortic valve prostheses

Patients receiving conventional biological aortic prostheses

Outcomes

Primary Outcome Measures

Differences in mid term trans prosthetic gradients

The differences in mid term trans prosthetic gradients measured by trans thoracic echocardiogram 6 months after the procedure

Secondary Outcome Measures

Survival from Combined major adverse cardiovascular event

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

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

Full Information

NCT ID

NCT03965065

First Posted

May 22, 2019

Last Updated

February 19, 2020

Sponsor

Hospital San Carlos, Madrid

1. Study Identification

Unique Protocol Identification Number

NCT03965065

Brief Title

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

Acronym

COPERA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 2, 2019 (Actual)

Primary Completion Date

May 30, 2020 (Anticipated)

Study Completion Date

May 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital San Carlos, Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Valve Prosthesis, Aortic Stenosis, Hemodynamics

Keywords

Aortic Stenosis, Heart Valve Prosthesis, Hemodynamics, Sutureless, Standard aortic valve prosthesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Block randomisation 1:1 of conventional Vs sutureless aortic bioprostheses.

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sutureless Aortic Valve Prosthesis

Arm Type

Experimental

Arm Description

Patients receiving sutureless aortic valve prostheses

Arm Title

Conventional Aortic Valve Prosthesis

Arm Type

Active Comparator

Arm Description

Patients receiving conventional biological aortic prostheses

Intervention Type

Device

Intervention Name(s)

Sutureless aortic bioprosthesis

Intervention Description

Patients will receive a sutureless aortic bioprosthesis

Intervention Type

Device

Intervention Name(s)

Conventional stented sutured aortic prosthesis

Intervention Description

Patients will receive a stented sutured aortic prosthesis

Primary Outcome Measure Information:

Title

Differences in mid term trans prosthetic gradients

Description

The differences in mid term trans prosthetic gradients measured by trans thoracic echocardiogram 6 months after the procedure

Time Frame

6 month

Secondary Outcome Measure Information:

Title

Survival from Combined major adverse cardiovascular event

Description

Time Frame

6 month

Title

Differences in quality if life according to the KCCQ12 questionnaire

Description

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Manuel Carnero, MD, PhD

Phone

+34913303000

Ext

3691

manuel.carnero@salud.madrid.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manuel Carnero, MD, PhD

Organizational Affiliation

Hospital Clinico San Carlos. Madrid. Spain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Clínico San Carlos

City

Madrid

ZIP/Postal Code

28222

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Manuel Carnero, MD, PhD

Phone

+34913303000

Ext

3691

manuel.carnero@salud.madrid.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs