Mitral Valve InsufficiencyPhase 4NCT01074671
CG Future® Annuloplasty Ring/Band Clinical Trial
A Phase 4 study testing CG Future Annuloplasty Ring/Band in people with Mitral Valve Insufficiency, run by Medtronic Cardiac Rhythm and Heart Failure at 8 sites in 5 countries.
Trial summary
The primary goal of the study is to document the number of patients that are successfully implanted and benefit from the implantation of both a CG Future Annuloplasty ring or a band. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- CG Future Annuloplasty Ring/Band
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Jun 2009to Sep 2011
- Phase
- Phase 4
- 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
Who may be able to join
- Signed and dated the Patient Informed Consent (PIC);
- Indicated to have a surgical repair for a given degree of moderate to severe mitral valve regurgitation;
- Willing to return to the implanting hospital for a 9 month follow-up visit
Who cannot join
- Unwilling or inability to sign the PIC;
- Already participating in another investigational device study, if this would create bias and jeopardize scientific appropriate assessment of the current study endpoints;
- Life expectancy of less than one year;
- Pregnant or desire to be pregnant within 12 months of the study treatment;
- Less than 18 years and more than 85 years of age.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Belgium3 sites
Cliniques Universitaires Saint Luc
Brussels, 1200
UZ Gent
Ghent, 9000
Virga Jesse Hospital
Hasselt, B-3500
Germany2 sites
Technische Universitat Dresden
Dresden, D-01307
Albertinen Krankenhaus Hamburg
Hamburg, 22457
About this study
Official title: Colvin-Galloway Future® Annuloplasty Ring/Band Clinical Trial: Interventional Multi-center Prospective Clinical Outcome Study
The primary goal of the study is to document the number of patients that are successfully implanted and benefit from the implantation of both a CG Future Annuloplasty ring or a band.
- Conditions
- Mitral Valve Insufficiency
- Being tested
- CG Future Annuloplasty Ring/Band
- 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.
CG Future Annuloplasty Ring/BandDevice
Also called Colvin Galloway Future Annuloplasty Ring, Colvin Galloway Future Annuloplasty Band, CG Future Annuloplasty Ring, CG Future Annuloplasty Band
A CG Future Annuloplasty Ring or Band will be implanted, following standard care
| Study group | Role | What they receive |
|---|---|---|
| No control arm | Other | There is no control arm as part of the study design. Receives: Device: CG Future Annuloplasty Ring/Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the patient population for which a CG Future Annuloplasty Ring or Band is chosen to repair the mitral valve insufficiency
Measured: Within 3 months prior to implantation
The percentage of patients that are chronically relieved from mitral valve insufficiency
Measured: Within 3 months prior to implantation and at 9 month follow-up
The level of mitral valve regurgitation
Measured: Within 3 months prior to implantation and at 9 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startJun 2009
- 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 Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- D C Iliopoulos, Prof, Principal investigator, Athens Medical Center, GreeceM Hendrikx, Dr, Principal investigator, Virga Jesse Hospital, Hasselt, BelgiumK François, Dr, Principal investigator, University Hospital, GhentG El Khoury, Dr, Principal investigator, Cliniques Universitaires Saint Luc, Brussels, BelgiumK Widenka, Dr, Principal investigator, Szpital Wojewódzki Nr 2 w Rzeszowie, PolandR. Haaverstad, Prof., Principal investigator, Haukeland Universitetssykehus, Bergen, NorwayK Matschke, Dr., Principal investigator, Technische Universitat Dresden, GermanyF Riess, Dr., Principal investigator, Albertinen Krankenhaus Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074671
- Sponsor's protocol ID
- BRC-CS-2009-06
- Status last verified
- Oct 2015
- First submitted
- 26 Jan 2010
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colvin-Galloway Future® Annuloplasty Ring/Band Clinical Trial: Interventional Multi-center Prospective Clinical Outcome Study
- ClinicalTrials.gov ID
- NCT01074671
- Acronym / sponsor ID
- BRC-CS-2009-06
- Conditions
- Mitral Valve Insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 24 Feb 2010 (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 primary goal of the study is to document the number of patients that are successfully implanted and benefit from the implantation of both a CG Future Annuloplasty ring or a band.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No control arm | Other | Device: CG Future Annuloplasty Ring/BandThere is no control arm as part of the study design. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed and dated the Patient Informed Consent (PIC);
- Indicated to have a surgical repair for a given degree of moderate to severe mitral valve regurgitation;
- Willing to return to the implanting hospital for a 9 month follow-up visit
Key exclusion criteria (5 listed)
- Unwilling or inability to sign the PIC;
- Already participating in another investigational device study, if this would create bias and jeopardize scientific appropriate assessment of the current study endpoints;
- Life expectancy of less than one year;
- Pregnant or desire to be pregnant within 12 months of the study treatment;
- Less than 18 years and more than 85 years of age.
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 |
|---|---|---|
| CG Future Annuloplasty Ring/BandAlso: Colvin Galloway Future Annuloplasty Ring, Colvin Galloway Future Annuloplasty Band, CG Future Annuloplasty Ring, CG Future Annuloplasty BandA CG Future Annuloplasty Ring or Band will be implanted, following standard care | Device | No control arm |
Primary outcome
Identification of the patient population for which a CG Future Annuloplasty Ring or Band is chosen to repair the mitral valve insufficiency
Time frame: Within 3 months prior to implantation
The percentage of patients that are chronically relieved from mitral valve insufficiency
Time frame: Within 3 months prior to implantation and at 9 month follow-up
The level of mitral valve regurgitation
Time frame: Within 3 months prior to implantation and at 9 month follow-up
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 29 Oct 2015.
- Related InfoLink provided by the sponsor.
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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.
D C Iliopoulos, Prof principal investigator
Athens Medical Center, Greece
M Hendrikx, Dr principal investigator
Virga Jesse Hospital, Hasselt, Belgium
K François, Dr principal investigator
University Hospital, Ghent
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CG Future Annuloplasty Ring/Band in people with Mitral Valve Insufficiency, run by Medtronic Cardiac Rhythm and Heart Failure at 8 sites in 5 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 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, Germany, Greece, Norway, Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Identification of the patient population for which a CG Future Annuloplasty Ring or Band is chosen to repair the mitral valve insufficiency (time frame: Within 3 months prior to implantation). The study lists 3 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 29 Oct 2015.