Mitral Valve InsufficiencyMITRALNCT00727012
Multicenter International Trial Ring AnnulopLasty
A study testing mitral valve repair (SJM® Rigid Saddle Ring) in people with Mitral Valve Insufficiency, run by Abbott Medical Devices at 1 site in Germany.
Trial summary
This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- mitral valve repair (SJM® Rigid Saddle Ring)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Nov 2010
- 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
- Patient requiring a mitral valve repair due to mitral degenerative or functional disease (Note: Patients that underwent concomitant procedures, e.g. coronary artery bypass grafting, are eligible for this study);
- Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements;
- Patients are at least 18 years old.
Who cannot join
- Patient requires replacement of the aortic, tricuspid or pulmonary valve or has a pre-existing prosthetic valve;
- Patient is pregnant or nursing;
- Patient has active endocarditis;
- Patient is actively participating in another study of an investigational drug or device;
- Patients unavailable to follow-up visit (abroad residents, patients affected by neurological disorders...);
- Patients who are intravenous drug abusers, alcohol abusers, prison inmates or unable to give informed consent;
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- Patients with a major non-cardiac evolving disease;
- Patients with a life expectancy less than 1 year;
- Patients are known to be noncompliant or are unlikely to complete the study;
- Any case in which mitral annuloplasty rings are not indicated;
Trial locations and contacts
1 site in 1 country.
About this study
This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included. The primary objective of the study is to demonstrate the effectiveness of the SJM® Rigid Saddle Ring when used in mitral valve repair procedures.
- Conditions
- Mitral Valve Insufficiency
- Being tested
- mitral valve repair (SJM® Rigid Saddle Ring)
- Keywords
- mitral valve, heart valve, valve repair, valve disorder, valve disease, cardiac surgery
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve repair (SJM® Rigid Saddle Ring)Device
mitral valve repair due to mitral degenerative or functional disease
| Study group | Role | What they receive |
|---|---|---|
| SJM® Rigid Saddle Ring | Other | The SJM® Rigid Saddle Ring is an annuloplasty ring comprised of a titanium core surrounded by a double-velour, polyester fabric sewing cuff. Receives: Device: mitral valve repair (SJM® Rigid Saddle Ring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ERO (Effective Regurgitant Orifice) in cm2 calculated with PISA method at 6 months and at patient discharge compared to baseline (pre-operative).
Measured: 6 months
NYHA class
Measured: 6 months
Secondary outcomes (1)
adverse events rates
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 posted1 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Raffaele De Simone, Prof. Dr., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727012
- Sponsor's protocol ID
- CS06003RG
- Acronym
- MITRAL
- Status last verified
- Feb 2019
- First submitted
- 29 Jul 2008
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter International Trial Ring AnnulopLasty
- ClinicalTrials.gov ID
- NCT00727012
- Acronym / sponsor ID
- MITRAL / CS06003RG
- Conditions
- Mitral Valve Insufficiency
- Keywords
- mitral valve, heart valve, valve repair, valve disorder, valve disease, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 1 Aug 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.
This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included. The primary objective of the study is to demonstrate the effectiveness of the SJM® Rigid Saddle Ring when used in mitral valve repair procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SJM® Rigid Saddle Ring | Other | Device: mitral valve repair (SJM® Rigid Saddle Ring)The SJM® Rigid Saddle Ring is an annuloplasty ring comprised of a titanium core surrounded by a double-velour, polyester fabric sewing cuff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient requiring a mitral valve repair due to mitral degenerative or functional disease (Note: Patients that underwent concomitant procedures, e.g. coronary artery bypass grafting, are eligible for this study);
- Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements;
- Patients are at least 18 years old.
Key exclusion criteria (10 listed)
- Patient requires replacement of the aortic, tricuspid or pulmonary valve or has a pre-existing prosthetic valve;
- Patient is pregnant or nursing;
- Patient has active endocarditis;
- Patient is actively participating in another study of an investigational drug or device;
- Patients unavailable to follow-up visit (abroad residents, patients affected by neurological disorders...);
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 |
|---|---|---|
| mitral valve repair (SJM® Rigid Saddle Ring)mitral valve repair due to mitral degenerative or functional disease | Device | SJM® Rigid Saddle Ring |
Primary outcome
Change in ERO (Effective Regurgitant Orifice) in cm2 calculated with PISA method at 6 months and at patient discharge compared to baseline (pre-operative).
Time frame: 6 months
NYHA class
Time frame: 6 months
1 secondary outcome
adverse events rates
Time frame: 6 months
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 4 Feb 2019.
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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.
Raffaele De Simone, Prof. Dr. principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mitral valve repair (SJM® Rigid Saddle Ring) in people with Mitral Valve Insufficiency, run by Abbott Medical Devices at 1 site in Germany.
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 10 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 4 Feb 2019. 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 Germany. 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?
Change in ERO (Effective Regurgitant Orifice) in cm2 calculated with PISA method at 6 months and at patient discharge compared to baseline (pre-operative). (time frame: 6 months). 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?
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 4 Feb 2019.