Mitral RegurgitationMITRAFITNCT01617720
MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)
An observational study of Mitral Regurgitation, run by Edwards Lifesciences at 2 sites in 2 countries.
Trial summary
This Study is designed to observe the clinical outcomes of patients requiring mitral repair that were treated with the CE certified Cardinal System. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mitral Regurgitation
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2012to Jun 2016
- Phase
- Observational
- 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
Study population: Patients who are candidate for mitral valve repair, with our without concomitant procedures.
Who may be able to join
- Age > 18 years
- Patient is a candidate for mitral valve repair, with our without concomitant procedures.
- Subject is willing to give informed consent for collection of his/her clinical data.
Who cannot join
- Severe organic lesions with retracted chordae
- Congenital malformations with lack of valvular tissue
- Severe valvular calcifications
- Evolving bacterial endocarditis
- Known Sensitivity to Nickel or Chromium
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: MITRAFIT Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)
This Study is designed to observe the clinical outcomes of patients requiring mitral repair that were treated with the CE certified Cardinal System.
- Conditions
- Mitral Regurgitation
- Keywords
- mitral, valve, annuloplasty, mitral regurgitation
- Medical subject headings
- Mitral Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
• Ability of the Cardinal ring to reduce mitral valve regurgitation
Measured: 30 day
• Percentage of patients in whom the size of the ring is adjusted
Measured: 6 months
• Technical feasibility of adjustment.
The ability of the surgeon to adjust the Cardinal ring when required, will be measured on a scale of 1-3 (1- successfull, 3- unsuccessful)
Measured: 6 months
• The occurrence of serious device related adverse events in all patients.
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 posted12 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2016
- Study completionJun 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 Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ottavio Alfieri, Prof, MD, Principal investigator, Hospital San Raffaele, Milan, ItalyNicolas Doll, Prof, MD, Principal investigator, SANA Herzchirurgie Stuttgart , GermanyEhud Raanani, Prof, MD, Principal investigator, Sheba Medical CenterPatrik Nataf, Prof, MD, Principal investigator, Bichat HospitalVolkmar Falk, Prof, MD, Principal investigator, Zurich University, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617720
- Sponsor's protocol ID
- VC1-2
- Acronym
- MITRAFIT
- Status last verified
- Oct 2021
- First submitted
- 7 Jun 2012
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Publications
Sundermann SH, Czesla M, Kempfert J, Walther T, Nataf P, Raanani E, Jacobs S, Alfieri O, Maisano F, Falk V. Results of mitral valve repair with an adjustable annuloplasty ring 2 years after implantation. Heart Vessels. 2017 Jul;32(7):843-849. doi: 10.1007/s00380-016-0934-7. Epub 2016 Dec 23.
PubMed 28012074
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MITRAFIT Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)
- ClinicalTrials.gov ID
- NCT01617720
- Acronym / sponsor ID
- MITRAFIT / VC1-2
- Conditions
- Mitral Regurgitation
- Keywords
- mitral, valve, annuloplasty, mitral regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Jun 2012 (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 Study is designed to observe the clinical outcomes of patients requiring mitral repair that were treated with the CE certified Cardinal System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are candidate for mitral valve repair, with our without concomitant procedures.
Key inclusion criteria (3 listed)
- Age > 18 years
- Patient is a candidate for mitral valve repair, with our without concomitant procedures.
- Subject is willing to give informed consent for collection of his/her clinical data.
Key exclusion criteria (5 listed)
- Severe organic lesions with retracted chordae
- Congenital malformations with lack of valvular tissue
- Severe valvular calcifications
- Evolving bacterial endocarditis
- Known Sensitivity to Nickel or Chromium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• Ability of the Cardinal ring to reduce mitral valve regurgitation
Time frame: 30 day
• Percentage of patients in whom the size of the ring is adjusted
Time frame: 6 months
• Technical feasibility of adjustment.
Time frame: 6 months
The ability of the surgeon to adjust the Cardinal ring when required, will be measured on a scale of 1-3 (1- successfull, 3- unsuccessful)
• The occurrence of serious device related adverse events in all patients.
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 5 Nov 2021.
- Background: PubMed 28012074Sundermann SH, Czesla M, Kempfert J, Walther T, Nataf P, Raanani E, Jacobs S, Alfieri O, Maisano F, Falk V. Results of mitral valve repair with an adjustable annuloplasty ring 2 years after implantation. Heart Vessels. 2017 Jul;32(7):843-849. doi: 10.1007/s00380-016-0934-7. Epub 2016 Dec 23.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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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.
Ottavio Alfieri, Prof, MD principal investigator
Hospital San Raffaele, Milan, Italy
Nicolas Doll, Prof, MD principal investigator
SANA Herzchirurgie Stuttgart , Germany
Ehud Raanani, Prof, MD principal investigator
Sheba Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation, run by Edwards Lifesciences at 2 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 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 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Italy. 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?
• Ability of the Cardinal ring to reduce mitral valve regurgitation (time frame: 30 day). The study lists 4 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 NCT01617720, 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 5 Nov 2021.