Mitral Valve InsufficiencyNCT02607527
Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System
A study testing Mitral Valve IRIS Ring in people with Mitral Valve Insufficiency, run by Boston Scientific Corporation at 2 sites in 2 countries.
Trial summary
Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- Mitral Valve IRIS Ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 May 2017to 19 Dec 2019
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of symptomatic severe MR (effective regurgitant orifice (ERO) ≥0.2 cm2 for Secondary MR, ERO ≥0.4 cm2 for Primary MR)
- The New York Heart Association Functional Class II, III or ambulatory IV.
- Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50%
- Creatine Kinase-MB (CK-MB) obtained within prior 14 days < local laboratory -Upper Limit of Normal (ULN).
- Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by TTE obtained within 90 days Exclusion Criteria: -Untreated clinically significant coronary artery disease requiring revascularization.
- Presence of any of the following:
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- Estimated pulmonary artery systolic pressure (PASP) > 70 mmHg assessed by site based on echocardiography or right heart catheterization
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
- Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
- Hemodynamic instability requiring inotropic support or mechanical heart assistance.
- Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
- Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.
- Coronary artery bypass grafting (CABG) within 30 days prior to subject's consent.
- Percutaneous coronary intervention within 30 days prior to subject's consent.
- Tricuspid valve disease requiring surgery.
- Aortic valve disease requiring surgery or TAVI.
- Carotid surgery within 30 days prior to subject registration.
- Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac -Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30 days prior to subject registration.
- Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
- Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure.
- Status 1 heart transplant or prior orthotopic heart transplantation.
- Chronic Kidney Disease.
- Chronic Steroid Therapy.
- Cerebrovascular accident within 30 days prior to subject's consent.
- Severe symptomatic carotid stenosis (> 70% by ultrasound).Life expectancy < 12 months due to non-cardiac conditions.
- Active infections requiring current antibiotic therapy.
- Pregnant or planning pregnancy within next 12 months.
- Currently participating in an investigational drug or another device study.
- Severe organic lesions with mitral chords retraction, severely fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
- endocarditis or active endocarditis in the last 3 months.
- Heavily calcified annulus or leaflets, mitral valve stenosis.
- Congenital malformation with limited valvular tissue
- Patient requires mitral valve replacement
- Previously implanted prosthetic mitral valve or annuloplasty ring/band.
- Evidence of LV or LA thrombus, vegetation or mass
- Left Ventricular Ejection Fraction <20%
- Left Ventricular End Diastolic Diameter >65 mm
- Severe tricuspid regurgitation or severe RV dysfunction
- Condition that prevents transatrial access or transfemoral access
- Anatomical ineligibility to the investigational device
- Known hypersensitivity or contraindication to procedural or post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
Read the detailed description
Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
This trial is designed in accordance with the 2014 ACC/AHA guidelines for valvular heart disease, and the consensus statement of MVARC 2015.
Subjects will undergo transcatheter implantation of the Millipede IRIS implant.
- Conditions
- Mitral Valve Insufficiency
- Being tested
- Mitral Valve IRIS Ring
- 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 IRIS RingDevice
Transcatheter implantation of the IRIS
| Study group | Role | What they receive |
|---|---|---|
| Device Implantation | Other | Transcatheter IRIS placement Receives: Device: Mitral Valve IRIS Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Safety defined as incidence of adverse events
30 days defined as ability to implant, anchor and actuate without incidence of adverse events
Measured: Procedure through 30 days post procedure
Secondary outcomes (1)
Efficacy assessed by reduction in mitral regurgitation without significant mitral stenosis as measured by echo
Reduction in mitral regurgitation to optimal or acceptable levels without significant mitral stenosis post procedure (defined as discharge or 48 hrs whichever comes first) and EROA <1.5 cm2 with transmitral gradient <5mm Hg as compared to screening echo
Measured: Procedural through 48 hrs post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start8 May 2017
- Primary completion17 Jan 2019
- Study completion19 Dec 2019
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 Boston Scientific CorporationThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandre Abizaid, MD, Principal investigator, Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607527
- Sponsor's protocol ID
- CP-002, CP-003
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2015
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System
- ClinicalTrials.gov ID
- NCT02607527
- Acronym / sponsor ID
- CP-002, CP-003
- Conditions
- Mitral Valve Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 May 2017 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 18 Nov 2015 (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.
Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
Detailed description
Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
This trial is designed in accordance with the 2014 ACC/AHA guidelines for valvular heart disease, and the consensus statement of MVARC 2015.
Subjects will undergo transcatheter implantation of the Millipede IRIS implant.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Implantation | Other | Device: Mitral Valve IRIS RingTranscatheter IRIS placement |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (41 listed)
- Presence of symptomatic severe MR (effective regurgitant orifice (ERO) ≥0.2 cm2 for Secondary MR, ERO ≥0.4 cm2 for Primary MR)
- The New York Heart Association Functional Class II, III or ambulatory IV.
- Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50%
- Creatine Kinase-MB (CK-MB) obtained within prior 14 days < local laboratory -Upper Limit of Normal (ULN).
- Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by TTE obtained within 90 days Exclusion Criteria: -Untreated clinically significant coronary artery disease requiring revascularization.
Key exclusion criteria (0 listed)
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 IRIS RingTranscatheter implantation of the IRIS | Device | Device Implantation |
Primary outcome
Acute Safety defined as incidence of adverse events
Time frame: Procedure through 30 days post procedure
30 days defined as ability to implant, anchor and actuate without incidence of adverse events
1 secondary outcome
Efficacy assessed by reduction in mitral regurgitation without significant mitral stenosis as measured by echo
Time frame: Procedural through 48 hrs post procedure
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 24 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Alexandre Abizaid, MD principal investigator
Dante Pazzanese de Cardiologia
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitral Valve IRIS Ring in people with Mitral Valve Insufficiency, run by Boston Scientific Corporation 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 41 inclusion and 0 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 24 Oct 2024. 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 Brazil, Paraguay. 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?
Acute Safety defined as incidence of adverse events (time frame: Procedure through 30 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 24 Oct 2024.