Heart Valve ProsthesisCOPERANCT03965065
Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement
A study testing Sutureless aortic bioprosthesis and Conventional stented sutured aortic prosthesis in people with Heart Valve Prosthesis and Aortic Stenosis, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Valve Prosthesis, Aortic Stenosis, Hemodynamics
- What is being tested?
- Sutureless aortic bioprosthesis and Conventional stented sutured aortic prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jun 2019to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18
- Pure aortic stenosis or combined aortic stenosis/regurgitation
- Aortic annulus >18 mm and < 27 mm
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico San Carlos
Madrid, 28222
Manuel Carnero, MD, PhD, +34913303000 ext. 3691, manuel.carnero@salud.madrid.org
About this study
Official title: Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement: a Randomised Multicenter Study (Madrid, Spain)
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
Read the 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
- Being tested
- Sutureless aortic bioprosthesis, Conventional stented sutured aortic prosthesis
- Keywords
- Aortic Stenosis, Heart Valve Prosthesis, Hemodynamics, Sutureless, Standard aortic valve prosthesis
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sutureless aortic bioprosthesisDevice
Patients will receive a sutureless aortic bioprosthesis
Conventional stented sutured aortic prosthesisDevice
Patients will receive a stented sutured aortic prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Sutureless Aortic Valve Prosthesis | Experimental | Patients receiving sutureless aortic valve prostheses Receives: Device: Sutureless aortic bioprosthesis |
| Conventional Aortic Valve Prosthesis | Active comparator | Patients receiving conventional biological aortic prostheses Receives: Device: Conventional stented sutured aortic prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 month
Secondary outcomes (2)
Survival from Combined major adverse cardiovascular event
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)
Measured: 6 month
Differences in quality if life according to the KCCQ12 questionnaire
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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start2 Jun 2019
- Primary completion30 May 2020 (estimated)
- Study completion30 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve ProsthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Block randomisation 1:1 of conventional Vs sutureless aortic bioprostheses.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Carnero Alcazar, Hospital San Carlos, Madrid
- Investigators
- Manuel Carnero, MD, PhD, Principal investigator, Hospital Clinico San Carlos. Madrid. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965065
- Sponsor's protocol ID
- 19/153-R_P
- Acronym
- COPERA
- Status last verified
- Feb 2020
- First submitted
- 22 May 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement: a Randomised Multicenter Study (Madrid, Spain)
- ClinicalTrials.gov ID
- NCT03965065
- Acronym / sponsor ID
- COPERA / 19/153-R_P
- Conditions
- Heart Valve Prosthesis, Aortic Stenosis, Hemodynamics
- Keywords
- Aortic Stenosis, Heart Valve Prosthesis, Hemodynamics, Sutureless, Standard aortic valve prosthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- 2 Jun 2019 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Block randomisation 1:1 of conventional Vs sutureless aortic bioprostheses.
| Arm | Type | Receives |
|---|---|---|
| Sutureless Aortic Valve Prosthesis | Experimental | Device: Sutureless aortic bioprosthesisPatients receiving sutureless aortic valve prostheses |
| Conventional Aortic Valve Prosthesis | Active comparator | Device: Conventional stented sutured aortic prosthesisPatients receiving conventional biological aortic prostheses |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18
- Pure aortic stenosis or combined aortic stenosis/regurgitation
- Aortic annulus >18 mm and < 27 mm
Key exclusion criteria (8 listed)
- Pregnancy
- Willing to receive some other prosthesis
- Concomitant surgery of the ascending aorta or left ventricle outflow tract
- Endocarditis
- Emergency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sutureless aortic bioprosthesisPatients will receive a sutureless aortic bioprosthesis | Device | Sutureless Aortic Valve Prosthesis |
| Conventional stented sutured aortic prosthesisPatients will receive a stented sutured aortic prosthesis | Device | Conventional Aortic Valve Prosthesis |
Primary outcome
Differences in mid term trans prosthetic gradients
Time frame: 6 month
The differences in mid term trans prosthetic gradients measured by trans thoracic echocardiogram 6 months after the procedure
2 secondary outcomes
Survival from Combined major adverse cardiovascular event
Time frame: 6 month
Differences in quality if life according to the KCCQ12 questionnaire
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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REVIVE-FR Registry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Carnero, MD, PhD principal investigator
Hospital Clinico San Carlos. Madrid. Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sutureless aortic bioprosthesis and Conventional stented sutured aortic prosthesis in people with Heart Valve Prosthesis and Aortic Stenosis, run by Hospital San Carlos, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel Carnero, MD, PhD (+34913303000 ext. 3691, manuel.carnero@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in mid term trans prosthetic gradients (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.