Aortic Valve DiseaseNCT00705913
Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna
A study testing Mitroflow Aortic Pericardial Heart Valve (CarboMedics) and Carpentier-Edwards Magna Tissue Valve in people with Aortic Valve Disease, run by Sorin Group USA, Inc. at 12 sites in 2 countries.
Trial summary
The purpose of this study is to compare sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Mitroflow Aortic Pericardial Heart Valve (CarboMedics) and Carpentier-Edwards Magna Tissue Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Jun 2008to Sep 2011
- 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 are indicated for implant with a bioprosthetic valve in the aortic position according to the current practice for valve selection at the center.
Who cannot join
- Less than 18 years of age
- Emergency Surgery
- Pre-existing valve prothesis in the aortic position
- Aortic root replacements or enlargements
- Active endocarditis
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States10 sites
The Ohio State University Medical Center
Columbus, Ohio, 43210
Duke University Hospital
Durham, North Carolina, 27705
St. Luke's Medical Center
Kansas City, Kansas, 64111
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Peninsula Regional Medical Center
Salisbury, Maryland, 21801
Sharp Memorial Hospital
San Diego, California, 92123
St. John's Medical Research Inst.
Springfield, Missouri, 65807
Pepin Heart Hospital
Tampa, Florida, 33613
Montefiore Medical Center
The Bronx, New York, 10467
Canada2 sites
Hopital Laval
Sainte-Foy, Quebec, G1V 6G5
St.Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: A Randomized Study to Compare Sizing, Implant Techniques and Hemodynamic Performance Between the Mitroflow and the Carpentier-Edwards Magna Pericardial Tissue Valves in the Aortic Position
The purpose of this study is to compare sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.
Read the detailed description
Comparisons of valve types are often made according to labeled valve sizes. There is growing evidence that in the majority of cases the actual sizer and valve dimensions vary from the labeled diameters, which may not be related to any hemodynamically meaningful dimension. The disagreement between the true valve dimensions and the labeled valve size may render comparisons based on labeled size meaningless
- Conditions
- Aortic Valve Disease
- Being tested
- Mitroflow Aortic Pericardial Heart Valve (CarboMedics), Carpentier-Edwards Magna Tissue Valve
- Keywords
- aortic valve, heart valve, valve replacement, valve disease
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitroflow Aortic Pericardial Heart Valve (CarboMedics)Device
Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Pericardial valve as compared to the Edwards Magna valve
Carpentier-Edwards Magna Tissue ValveDevice
Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Valve as compared to the Edwards Magna valve
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Mitroflow Aortic Pericardial Heart Valve (CarboMedics) Receives: Device: Mitroflow Aortic Pericardial Heart Valve (CarboMedics) |
| 2 | Active comparator | Not described Receives: Device: Carpentier-Edwards Magna Tissue Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate lower pressure gradients relative to aortic annulus
Measured: 6 months
Secondary outcomes (1)
Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate higher ratio of EOA to the aortic annulus area.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorin Group USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705913
- Sponsor's protocol ID
- MRVSS-02
- Status last verified
- Nov 2011
- First submitted
- 18 Jun 2008
- Last updated
- 9 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Compare Sizing, Implant Techniques and Hemodynamic Performance Between the Mitroflow and the Carpentier-Edwards Magna Pericardial Tissue Valves in the Aortic Position
- ClinicalTrials.gov ID
- NCT00705913
- Acronym / sponsor ID
- MRVSS-02
- Conditions
- Aortic Valve Disease
- Keywords
- aortic valve, heart valve, valve replacement, valve disease
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Sorin Group USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Jun 2008 (estimated)
- 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 purpose of this study is to compare sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.
Detailed description
Comparisons of valve types are often made according to labeled valve sizes. There is growing evidence that in the majority of cases the actual sizer and valve dimensions vary from the labeled diameters, which may not be related to any hemodynamically meaningful dimension. The disagreement between the true valve dimensions and the labeled valve size may render comparisons based on labeled size meaningless
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Mitroflow Aortic Pericardial Heart Valve (CarboMedics)Mitroflow Aortic Pericardial Heart Valve (CarboMedics) |
| 2 | Active comparator | Device: Carpentier-Edwards Magna Tissue Valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are indicated for implant with a bioprosthetic valve in the aortic position according to the current practice for valve selection at the center.
Key exclusion criteria (5 listed)
- Less than 18 years of age
- Emergency Surgery
- Pre-existing valve prothesis in the aortic position
- Aortic root replacements or enlargements
- Active endocarditis
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 |
|---|---|---|
| Mitroflow Aortic Pericardial Heart Valve (CarboMedics)Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Pericardial valve as compared to the Edwards Magna valve | Device | 1 |
| Carpentier-Edwards Magna Tissue ValveStudy to compare sizing, implant techniques and hemodynamics of the Mitroflow Valve as compared to the Edwards Magna valve | Device | 2 |
Primary outcome
Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate lower pressure gradients relative to aortic annulus
Time frame: 6 months
1 secondary outcome
Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate higher ratio of EOA to the aortic annulus area.
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitroflow Aortic Pericardial Heart Valve (CarboMedics) and Carpentier-Edwards Magna Tissue Valve in people with Aortic Valve Disease, run by Sorin Group USA, Inc. at 12 sites in 2 countries.
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 1 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: stopped early, as of the sponsor's last update on 9 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. 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 was stopped early. Results are not available in the source record.
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?
Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate lower pressure gradients relative to aortic annulus (time frame: 6 months). 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 9 Jan 2012.