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出境医 / 临床实验 / Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement (COPERA)
Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement (COPERA)
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 | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 350 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 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 : | June 2, 2019 |
| Estimated Primary Completion Date : | May 30, 2020 |
| Estimated 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 :
- 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
Secondary Outcome Measures :
- Survival from Combined major adverse cardiovascular event [ Time Frame: 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)
- Differences in quality if life according to the KCCQ12 questionnaire [ Time Frame: 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
| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts
| Contact: Manuel Carnero, MD, PhD | +34913303000 ext 3691 | manuel.carnero@salud.madrid.org |
Locations
| Spain | |
| Hospital Clínico San Carlos | Recruiting |
| Madrid, Spain, 28222 | |
| Contact: Manuel Carnero, MD, PhD +34913303000 ext 3691 manuel.carnero@salud.madrid.org | |
Sponsors and Collaborators
Hospital San Carlos, Madrid
Investigators
| Principal Investigator: | Manuel Carnero, MD, PhD | Hospital Clinico San Carlos. Madrid. Spain |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 22, 2019 | ||||||
| First Posted Date ICMJE | May 28, 2019 | ||||||
| Last Update Posted Date | February 20, 2020 | ||||||
| Actual Study Start Date ICMJE | June 2, 2019 | ||||||
| Estimated Primary Completion Date | May 30, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement | ||||||
| Official Title ICMJE | Comparison of Sutureless Vs. Standard Biological Prostheses for Surgical Aortic Valve Replacement: a Randomised Multicenter Study (Madrid, Spain) | ||||||
| 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:
|
||||||
| 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 |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Block randomisation 1:1 of conventional Vs sutureless aortic bioprostheses. Masking: Double (Investigator, Outcomes Assessor)Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE |
350 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | May 30, 2020 | ||||||
| Estimated Primary Completion Date | May 30, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Spain | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03965065 | ||||||
| Other Study ID Numbers ICMJE | 19/153-R_P | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Manuel Carnero Alcazar, Hospital San Carlos, Madrid | ||||||
| Study Sponsor ICMJE | Hospital San Carlos, Madrid | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Hospital San Carlos, Madrid | ||||||
| Verification Date | February 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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