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

Aortic Stenosis Clinical Trial

— COPERA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03965065
• Other study ID #: 19/153-R_P
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: February 2020
• Source: Hospital San Carlos, Madrid
• Contact: Manuel Carnero, MD, PhD
• Phone: +34913303000
• Email: manuel.carnero[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Heart Valve Prosthesis
• Hemodynamics

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 month
Secondary	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)	6 month
Secondary	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	6 month