NCT03965065

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Hospital San Carlos, Madrid · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Heart Valve Prosthesis
• Aortic Stenosis
• Hemodynamics

Interventions

Type	Name	Description
DEVICE	Sutureless aortic bioprosthesis	Patients will receive a sutureless aortic bioprosthesis
DEVICE	Conventional stented sutured aortic prosthesis	Patients will receive a stented sutured aortic prosthesis

Timeline

• Start date: 2019-06-02
• Primary completion: 2020-05-30
• Completion: 2020-05-30
• First posted: 2019-05-28
• Last updated: 2020-02-20

Locations

1 site across 1 country: Spain