Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement
COPERA
1 other identifier
interventional
350
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2019
CompletedFirst Posted
Study publicly available on registry
May 28, 2019
CompletedStudy Start
First participant enrolled
June 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2020
CompletedFebruary 20, 2020
February 1, 2020
12 months
May 22, 2019
February 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Survival from Combined major adverse cardiovascular event
6 month
Differences in quality if life according to the KCCQ12 questionnaire
6 month
Study Arms (2)
Sutureless Aortic Valve Prosthesis
EXPERIMENTALPatients receiving sutureless aortic valve prostheses
Conventional Aortic Valve Prosthesis
ACTIVE COMPARATORPatients receiving conventional biological aortic prostheses
Interventions
Patients will receive a sutureless aortic bioprosthesis
Patients will receive a stented sutured aortic prosthesis
Eligibility Criteria
You may qualify if:
- Patients older than 18
- Pure aortic stenosis or combined aortic stenosis/regurgitation
- Aortic annulus \>18 mm and \< 27 mm
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínico San Carlos
Madrid, 28222, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manuel Carnero, MD, PhD
Hospital Clinico San Carlos. Madrid. Spain
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adult Cardiac Surgeon, MD, PhD
Study Record Dates
First Submitted
May 22, 2019
First Posted
May 28, 2019
Study Start
June 2, 2019
Primary Completion
May 30, 2020
Study Completion
May 30, 2020
Last Updated
February 20, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share