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

Not Applicable

• Conditions: Heart Valve Prosthesis; Aortic Stenosis; Hemodynamics
• Interventions: Device: Sutureless aortic bioprosthesis; Device: Conventional stented sutured aortic prosthesis

• Registration Number: NCT03965065
• Lead Sponsor: Hospital San Carlos, Madrid

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

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-28
• Study Start: 2019-06-02
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20
• Primary Completion: 2020-05-30
• Study Completion: 2020-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sutureless Aortic Valve Prosthesis	Sutureless aortic bioprosthesis	Patients receiving sutureless aortic valve prostheses
Conventional Aortic Valve Prosthesis	Conventional stented sutured aortic prosthesis	Patients receiving conventional biological aortic prostheses

Primary Outcome Measures

Name	Time	Method
Differences in mid term trans prosthetic gradients	6 month	The differences in mid term trans prosthetic gradients measured by trans thoracic echocardiogram 6 months after the procedure

Secondary Outcome Measures

Name	Time	Method
Differences in quality if life according to the KCCQ12 questionnaire	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
Survival from Combined major adverse cardiovascular event	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)

Trial Locations

Locations (1)

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain