Cardiac Valve ReplacementNCT03346044
Medtronic's MOSAIC Bioprosthesis Versus Baxter Carpentier-Edwards SAV Porcine Valve
A study testing Carpentier-Edwards SAV bioprostheses and Medtronic Mosaic bioprostheses in people with Cardiac Valve Replacement, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
The study compares the clinical performance of the Mosaic valve with that of the Baxter valve (Carpentier-Edwards) which is widely used throughout the UK and is considered to be the "bench mark". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Valve Replacement
- What is being tested?
- Carpentier-Edwards SAV bioprostheses and Medtronic Mosaic bioprostheses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2001to 12 Jan 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who require isolated or combined aortic or mitral valve replacement with or without coronary artery bypass grafting
- Patients requesting anticoagulation-free therapy
- Patients who are able to provide informed consent
Who cannot join
- Concomitant procedures other than coronary artery bypass grafting
- Presence of illness other than valve disease that would substantially increase the likelihood of death within one year
- Patients unlikely to be available for long term follow-up activities
- Patients indicated for receiving a mechanical prosthesis
- Patients refusing or not able to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Plymouth Hospitals NHS Trust
Plymouth, Devon, PL6 8BX
About this study
Official title: Medtronic's MOSAIC Bioprosthesis Versus Baxter Carpentier-Edwards SAV Porcine Valve: A Longterm Prospective Randomized Clinical Evaluation
The study compares the clinical performance of the Mosaic valve with that of the Baxter valve (Carpentier-Edwards) which is widely used throughout the UK and is considered to be the "bench mark".
Specific objectives will be to determine structural failure and valve explantation rates, thromboembolic events and mortality rates for each valve.
Haemodynamic assessments will also be made using echocardiography to measure gradients across the valves and changes in left ventricular function and wall thickness.
Read the detailed description
The bioprostheses (xenografts) to be used in this study are third generation valves derived from porcine aortic valves. The chief advantage over mechanical prostheses is that they do not require lifelong anticoagulation with warfarin with its attendant risks of haemorrhage if the patient becomes over anticoagulated, or thromboembolism if anticoagulation is inadequate. However their disadvantage is that they are prone to calcification and mechanical failure over time. Because of this, bioprosthetic valves are usually reserved for older patients in whom the chance of repeat surgery is reduced.
The Medtronic Mosaic stented bioprosthesis has been recently introduced. The Mosaic bioprosthesis utilizes Physiological Fixation (root fixation with zero pressure differential across the valve leaflets). This allows valves to maintain their natural leaflet structure and root geometry. The Mosaic bioprosthesis uses the AOA anti-mineralisation treatment. Developed in collaboration with Biomedical Design, Inc., AOA has been shown in multiple animal studies to be an effective treatment in preventing leaflet calcification.
Baxter currently produces the Carpentier Edwards SAV porcine bioprosthesis that has abundant long-term follow-up data and is widely used. Low pressure fixation (less than 1.5mmHg) and anti-mineralisation treatment with FET 80TM are used in its preparation. The stent (which supports the cusps) has been designed to allow for the wider opening angle of the softer leaflets.
These features aim to improve on the haemodynamic performance of earlier generation valves and offer the potential for increased durability. Early results look promising with excellent haemodynamic parameters and remarkably low rates of structural failure.
If zero pressure fixation and anti-mineralisation treatment can be shown to increase the longevity of the bioprosthetic valve, the age criteria for implantation will undoubtedly be lowered allowing a younger cohort of patients to benefit from anticoagulation-free therapy and freedom from associated morbidities.
- Conditions
- Cardiac Valve Replacement
- Being tested
- Carpentier-Edwards SAV bioprostheses, Medtronic Mosaic bioprostheses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carpentier-Edwards SAV bioprosthesesDevice
Performance of these bioprostheses
Medtronic Mosaic bioprosthesesDevice
| Study group | Role | What they receive |
|---|---|---|
| Carpentier-Edwards SAV bioprostheses | Active comparator | Not described Receives: Device: Carpentier-Edwards SAV bioprostheses |
| Medtronic Mosaic bioprostheses | Active comparator | Not described Receives: Device: Medtronic Mosaic bioprostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Early mortality was defined as death occurring within 30 days of implantation if the patient was discharged from hospital or at any time after implantation if the patient was not discharged from hospital. Hospital-to-hospital transfer was not considered as discharge. Late mortality was defined as all deaths that occurred after 30 days of implant, if the patient was discharged from hospital.
The reporting of mortality and morbidity follows the guidelines of the Society of Thoracic Surgeons (STS), the American Association of Thoracic Surgeons (AATS) and the European Association for Cardiothoracic Surgery (EACTS). () Edmunds LH, Clark R, Cohn L, et al. Guidelines for Reporting Morbidity and MortalityAfter Cardiac Valvular Operations. Ann Thorac Surg 1996;62:932-5)
Measured: 10 years
Freedom from structural valve deterioration (SVD)
Defined as re-operation and thromboembolic events. Valve-related complications were defined as thromboembolism, structural valve dysfunction, non-structural valve dysfunction and prosthetic valve endocarditis.
Measured: 10 years
Secondary outcomes (2)
Haemodynamic performance (mmHg)
Transvalvular gradients measured in mmHg
Measured: 10 years
Left ventricular (LV) mass regression (grams)
Evidence of left ventricular mass regression measured in grams
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Jan 2001
- Primary completion2 Feb 2006
- Study completion12 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Valve ReplacementStudies 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
- A comparative single centre study of two porcine bioprostheses indicated for the surgical treatment of heart valve diseases. The study will compare two equal sized patient groups using either the Medtronic Mosaic and Carpentier-Edwards SAV bioprostheses.
- Masking
- None (open label)
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Jonathan Unsworth-White, University Hospital Plymouth NHS Trust
- Investigators
- Jonathan Unsworth-White, BSc FRCS, Principal investigator, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346044
- Sponsor's protocol ID
- 1301
- Status last verified
- Nov 2017
- First submitted
- 8 Sep 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zibdeh O, Bugg I, Patel S, Twine G, Unsworth-White J. Randomized trial of the Carpentier-Edwards supra-annular prosthesis versus the Medtronic Mosaic aortic prosthesis: 10-year results. Eur J Cardiothorac Surg. 2018 Aug 1;54(2):281-287. doi: 10.1093/ejcts/ezx512.
PubMed 29401266
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medtronic's MOSAIC Bioprosthesis Versus Baxter Carpentier-Edwards SAV Porcine Valve: A Longterm Prospective Randomized Clinical Evaluation
- ClinicalTrials.gov ID
- NCT03346044
- Acronym / sponsor ID
- 1301
- Conditions
- Cardiac Valve Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 428 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- 1 Jan 2001 (actual)
- Primary completion
- 2 Feb 2006 (actual)
- Study completion
- 12 Jan 2016 (actual)
- First posted
- 17 Nov 2017 (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.
The study compares the clinical performance of the Mosaic valve with that of the Baxter valve (Carpentier-Edwards) which is widely used throughout the UK and is considered to be the "bench mark".
Specific objectives will be to determine structural failure and valve explantation rates, thromboembolic events and mortality rates for each valve.
Haemodynamic assessments will also be made using echocardiography to measure gradients across the valves and changes in left ventricular function and wall thickness.
Detailed description
The bioprostheses (xenografts) to be used in this study are third generation valves derived from porcine aortic valves. The chief advantage over mechanical prostheses is that they do not require lifelong anticoagulation with warfarin with its attendant risks of haemorrhage if the patient becomes over anticoagulated, or thromboembolism if anticoagulation is inadequate. However their disadvantage is that they are prone to calcification and mechanical failure over time. Because of this, bioprosthetic valves are usually reserved for older patients in whom the chance of repeat surgery is reduced.
The Medtronic Mosaic stented bioprosthesis has been recently introduced. The Mosaic bioprosthesis utilizes Physiological Fixation (root fixation with zero pressure differential across the valve leaflets). This allows valves to maintain their natural leaflet structure and root geometry. The Mosaic bioprosthesis uses the AOA anti-mineralisation treatment. Developed in collaboration with Biomedical Design, Inc., AOA has been shown in multiple animal studies to be an effective treatment in preventing leaflet calcification.
Baxter currently produces the Carpentier Edwards SAV porcine bioprosthesis that has abundant long-term follow-up data and is widely used. Low pressure fixation (less than 1.5mmHg) and anti-mineralisation treatment with FET 80TM are used in its preparation. The stent (which supports the cusps) has been designed to allow for the wider opening angle of the softer leaflets.
These features aim to improve on the haemodynamic performance of earlier generation valves and offer the potential for increased durability. Early results look promising with excellent haemodynamic parameters and remarkably low rates of structural failure.
If zero pressure fixation and anti-mineralisation treatment can be shown to increase the longevity of the bioprosthetic valve, the age criteria for implantation will undoubtedly be lowered allowing a younger cohort of patients to benefit from anticoagulation-free therapy and freedom from associated morbidities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A comparative single centre study of two porcine bioprostheses indicated for the surgical treatment of heart valve diseases. The study will compare two equal sized patient groups using either the Medtronic Mosaic and Carpentier-Edwards SAV bioprostheses.
| Arm | Type | Receives |
|---|---|---|
| Carpentier-Edwards SAV bioprostheses | Active comparator | Device: Carpentier-Edwards SAV bioprostheses |
| Medtronic Mosaic bioprostheses | Active comparator | Device: Medtronic Mosaic bioprostheses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who require isolated or combined aortic or mitral valve replacement with or without coronary artery bypass grafting
- Patients requesting anticoagulation-free therapy
- Patients who are able to provide informed consent
Key exclusion criteria (5 listed)
- Concomitant procedures other than coronary artery bypass grafting
- Presence of illness other than valve disease that would substantially increase the likelihood of death within one year
- Patients unlikely to be available for long term follow-up activities
- Patients indicated for receiving a mechanical prosthesis
- Patients refusing or not able to provide informed consent
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 |
|---|---|---|
| Carpentier-Edwards SAV bioprosthesesPerformance of these bioprostheses | Device | Carpentier-Edwards SAV bioprostheses |
| Medtronic Mosaic bioprostheses | Device | Medtronic Mosaic bioprostheses |
Primary outcome
Mortality
Time frame: 10 years
Early mortality was defined as death occurring within 30 days of implantation if the patient was discharged from hospital or at any time after implantation if the patient was not discharged from hospital. Hospital-to-hospital transfer was not considered as discharge. Late mortality was defined as all deaths that occurred after 30 days of implant, if the patient was discharged from hospital. The reporting of mortality and morbidity follows the guidelines of the Society of Thoracic Surgeons (STS), the American Association of Thoracic Surgeons (AATS) and the European Association for Cardiothoracic Surgery (EACTS). () Edmunds LH, Clark R, Cohn L, et al. Guidelines for Reporting Morbidity and MortalityAfter Cardiac Valvular Operations. Ann Thorac Surg 1996;62:932-5)
Freedom from structural valve deterioration (SVD)
Time frame: 10 years
Defined as re-operation and thromboembolic events. Valve-related complications were defined as thromboembolism, structural valve dysfunction, non-structural valve dysfunction and prosthetic valve endocarditis.
2 secondary outcomes
Haemodynamic performance (mmHg)
Time frame: 10 years
Left ventricular (LV) mass regression (grams)
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 29401266Zibdeh O, Bugg I, Patel S, Twine G, Unsworth-White J. Randomized trial of the Carpentier-Edwards supra-annular prosthesis versus the Medtronic Mosaic aortic prosthesis: 10-year results. Eur J Cardiothorac Surg. 2018 Aug 1;54(2):281-287. doi: 10.1093/ejcts/ezx512.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Valve Replacement
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
RecruitingObservational study
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
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.
Jonathan Unsworth-White, BSc FRCS principal investigator
University Hospital Plymouth NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carpentier-Edwards SAV bioprostheses and Medtronic Mosaic bioprostheses in people with Cardiac Valve Replacement, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
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 5 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: finished, as of the sponsor's last update on 17 Nov 2017. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03346044, which also lists 1 linked publication.
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 17 Nov 2017.