Mitral RegurgitationMiBANDNCT03600688
Edwards Cardioband European Post-Market Study, MiBAND
An observational study of Mitral Regurgitation and Mitral Insufficiency, run by Edwards Lifesciences at 17 sites in 3 countries.
Trial summary
To demonstrate reduction of MR with durable performance and im-provements in functional status Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Mitral Insufficiency, Mitral Repair
- What is being tested?
- Edwards Cardioband System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 6 Jun 2018to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic patients with mitral regurgitation (MR).
Main Inclusion Criteria:
- Age ≥ 18 years;
- MR (≥ 2+ by echocardiography);
- Patient is eligible to receive the Edwards Cardioband Mitral System
Main Exclusion Criteria:
- Active bacterial endocarditis
- Severe organic lesions with retracted chordae or congenital mal-formations with lack of valvular tissue
- Heavily calcified annulus or leaflets
- Patients in whom transesophageal echocardiography is contraindicated
- Patients who cannot tolerate an anticoagulation/antiplatelet regimen
- Patients with known severe reaction to contrast agents that cannot be adequately pre-medicated.
- Pre-existing prosthetic heart valve or annuloplasty in the Mitral position
- Life expectancy of less than twelve months
- Patient is pregnant or lactating
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
Germany11 sites
Herz- und Diabeteszentrum NRW Bad Oeynhausen
Bad Oeynhausen
Berlin Charité - Campus Benjamin Franklin
Berlin
Universitätsklinikum Bonn
Bonn
Herzzentrum UniKlinik Köln
Cologne
Herzzentrum Universitästklinik Dresden
Dresden
Düsseldorf University Hospital
Düsseldorf
Goethe-University Frankfurt - Surgery Center
Frankfurt am Main
Universitätsmedizin Göttingen
Göttingen
Asklepios Klinik St Georg
Hamburg
Universtitätsmedizin Mainz
Mainz
Universitätsklinikum Münster
Münster
Italy5 sites
Policlinico Vittorio-Emanuelle
Catania
Ospedale del Cuore G. Pasquinucci - Fondazione Toscana Gabreile Monasterio
Massa
Ospedale San Raffaele
Milan
Azienda Ospedaliera Universitaria Pisana
Pisa
Policlinico San Donato
San Donato Milanese
About this study
Official title: Transcatheter Repair of Mitral Regurgitation With Cardioband System Post Market Study:A European Prospective, Multicenter Study to Assess Transcatheter Mitral Valve Repair With Edwards Cardioband System in Patients With Symptomatic MR
To demonstrate reduction of MR with durable performance and im-provements in functional status
Read the detailed description
MiBAND is a prospective, single arm, European post-market study to assess the safety and efficacy of the Edwards Cardioband system. Patients will be followed up at 30D, 6months, 1, 2 and 3 years.
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Repair, Mitral Valve, Annuloplasty, Edwards Cardioband
- Being tested
- Edwards Cardioband System
- 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.
Edwards Cardioband SystemDevice
Transcatheter mitral valve repair
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Success at discharge
Reduction in Severity of Mitral Regurgitation at discharge
Measured: Hospital discharge; approximately 2-8 days post-procedure
Secondary outcomes (4)
Procedure Success
Reduction in Severity of Mitral Regurgitation
Measured: 30 days, 6months, 1, 2 and 3 years
Major Adverse Events Rate
Rate of Major Adverse Events
Measured: 30 days, 6months, 1, 2 and 3 years
Change in Quality Of Life-KCCQ
Improvements in Quality Of Life as assessed by KCCQ
Measured: 30 days, 6 months, 1, 2 and 3 years
Change in Quality Of Life-EQ-5D-5L
Improvements in Quality Of Life as assessed by EQ-5D-5L
Measured: 30 days, 6 months, 1, 2 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start6 Jun 2018
- Primary completion30 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Baldus, MD, Principal investigator, Herzzentrum UniKlinik Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600688
- Sponsor's protocol ID
- 2017-10
- Acronym
- MiBAND
- Status last verified
- Jan 2023
- First submitted
- 15 Jun 2018
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Repair of Mitral Regurgitation With Cardioband System Post Market Study:A European Prospective, Multicenter Study to Assess Transcatheter Mitral Valve Repair With Edwards Cardioband System in Patients With Symptomatic MR
- ClinicalTrials.gov ID
- NCT03600688
- Acronym / sponsor ID
- MiBAND / 2017-10
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Repair, Mitral Valve, Annuloplasty, Edwards Cardioband
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Jul 2018 (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.
To demonstrate reduction of MR with durable performance and im-provements in functional status
Detailed description
MiBAND is a prospective, single arm, European post-market study to assess the safety and efficacy of the Edwards Cardioband system. Patients will be followed up at 30D, 6months, 1, 2 and 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic patients with mitral regurgitation (MR).
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 |
|---|---|---|
| Edwards Cardioband SystemTranscatheter mitral valve repair | Device | – |
Primary outcome
Procedure Success at discharge
Time frame: Hospital discharge; approximately 2-8 days post-procedure
Reduction in Severity of Mitral Regurgitation at discharge
4 secondary outcomes
Procedure Success
Time frame: 30 days, 6months, 1, 2 and 3 years
Major Adverse Events Rate
Time frame: 30 days, 6months, 1, 2 and 3 years
Change in Quality Of Life-KCCQ
Time frame: 30 days, 6 months, 1, 2 and 3 years
Change in Quality Of Life-EQ-5D-5L
Time frame: 30 days, 6 months, 1, 2 and 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
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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.
Stephan Baldus, MD principal investigator
Herzzentrum UniKlinik Köln
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation and Mitral Insufficiency, run by Edwards Lifesciences at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Italy, Switzerland. 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?
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?
Procedure Success at discharge (time frame: Hospital discharge; approximately 2-8 days post-procedure). 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 26 Jan 2023.