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

San Carlos Clinical Hospital

Status: Unknown

Conditions: Heart Valve Prosthesis; Aortic Stenosis; Hemodynamics

Treatments: Device: Conventional stented sutured aortic prosthesis; Device: Sutureless aortic bioprosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT03965065

19/153-R_P

Details and patient eligibility

About

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

Full 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

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

350 participants in 2 patient groups

Sutureless Aortic Valve Prosthesis

Experimental group

Description:

Patients receiving sutureless aortic valve prostheses

Treatment:

Device: Sutureless aortic bioprosthesis

Conventional Aortic Valve Prosthesis

Active Comparator group

Description:

Patients receiving conventional biological aortic prostheses

Treatment:

Device: Conventional stented sutured aortic prosthesis