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

• Sponsor: Hospital San Carlos, Madrid (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03965065
• Collaborator: (none)
• Enrollment: 350
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.9
• Patients Per Site Per Month: 29.3

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Heart Valve Prosthesis; Aortic Stenosis; Hemodynamics	Device: Sutureless aortic bioprosthesis; Device: Conventional stented sutured aortic prosthesis	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Block randomisation 1:1 of conventional Vs sutureless aortic bioprostheses.Block randomisation 1:1 of conventional Vs sutureless aortic bioprostheses.
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement: a Randomised Multicenter Study (Madrid, Spain)
• Actual Study Start Date: Jun 2, 2019
• Anticipated Primary Completion Date: May 30, 2020
• Anticipated Study Completion Date: May 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sutureless Aortic Valve Prosthesis Patients receiving sutureless aortic valve prostheses	Device: Sutureless aortic bioprosthesis; Patients will receive a sutureless aortic bioprosthesis
Active Comparator: Conventional Aortic Valve Prosthesis Patients receiving conventional biological aortic prostheses	Device: Conventional stented sutured aortic prosthesis; Patients will receive a stented sutured aortic prosthesis

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clínico San Carlos	Madrid		Spain	28222

Sponsors and Collaborators

• Hospital San Carlos, Madrid

Investigators

• Principal Investigator: Manuel Carnero, MD, PhD, Hospital Clinico San Carlos. Madrid. Spain

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manuel Carnero Alcazar, Adult Cardiac Surgeon, MD, PhD, Hospital San Carlos, Madrid
• ClinicalTrials.gov Identifier: NCT03965065
• Other Study ID Numbers: 19/153-R_P
• First Posted: May 28, 2019
• Last Update Posted: Feb 20, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Manuel Carnero Alcazar, Adult Cardiac Surgeon, MD, PhD, Hospital San Carlos, Madrid: Aortic Stenosis; Heart Valve Prosthesis; Hemodynamics; Sutureless; Standard aortic valve prosthesis
• Additional relevant MeSH terms: Aortic Valve Stenosis

Study Results

No Results Posted as of Feb 20, 2020