Mitral Regurgitation FunctionalNCT04147884
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
A study testing Millipede Transcatheter Annuloplasty Ring System (Millipede System) in people with Mitral Regurgitation Functional and Mitral Valve Disease, run by Boston Scientific Corporation at 4 sites in 2 countries.
Trial summary
To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation Functional, Mitral Valve Disease, Cardiovascular Diseases
- What is being tested?
- Millipede Transcatheter Annuloplasty Ring System (Millipede System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 13 Nov 2019to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subject is 18 years of age or older
- Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
- Subject has moderate to severe (3+) or severe (4+) functional mitral regurgitation confirmed by echocardiography core lab
- Subject is symptomatic (NYHA Class II-IV) despite guideline directed medical therapy, including CRT if indicated
- The local site heart team concurs that mitral valve surgery will not be offered as a first-line treatment option
- Subject is a candidate for annuloplasty based on the criteria below as assessed by the investigative site (and confirmed by the Case Review Committee [CRC]):
- Left Ventricular Ejection Fraction (LVEF) ≥ 25% Left Ventricular End Diastolic Diameter (LVEDD) ≤ 65 mm Coaptation distance (i.e. tenting height) < 10 mm Absence of posterior wall aneurysm
Who cannot join
- Subject has severe calcification of the mitral annulus or leaflets or other anatomic features that make the subject unsuitable for annuloplasty with the Millipede System in the judgment of the treating physician or subject does not have suitable mitral annular diameter (determined by CT) as per the Instructions for Use
- Transfemoral venous and transseptal access determined not to be feasible
- Subject is on the waiting list for a transplant or has had a prior heart transplant
- Subject has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 30 days prior to study enrollment
- Subject has had any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to study enrollment
- Subject has had carotid surgery within 30 days prior to study enrollment
Show all 28Show fewer
- Subject has had any open coronary or vascular surgery (other than carotid surgery) within 3 months prior to study enrollment
- Subject has had a cardiac resynchronization therapy (CRT) device implantation within 3 months prior to study enrollment
- Subject has untreated clinically significant coronary artery disease requiring revascularization
- Any planned cardiac surgery within the next 12 months
- Need for emergent or urgent surgery for any reason
- Subject has severe aortic valve stenosis and/or aortic valve regurgitation
- Subject has physical evidence of right-sided congestive heart failure (CHF) with echocardiographic evidence of moderate or severe right ventricular dysfunction and/or severe tricuspid valve regurgitation
- Subject has the presence of prosthetic heart valve in any position
- Subject has renal insufficiency (eGFR <20mL/min) and is not on dialysis
- Subject has a life expectancy less than 12 months
- Subjects in whom trans-esophageal echocardiography-Doppler assessment is contraindicated or in which mitral regurgitation is not measurable by Transthoracic Echocardiography (TTE)
- Subject has a prior history of atrial septal defect (ASD) closure or patient foramen ovale (PFO) closure
- Subject has fixed pulmonary artery systolic pressure > 70 mmHG
- Subject has known hypersensitivity or contraindication to protocol required procedural or post procedural medication (e.g., anticoagulation therapy) or hypersensitivity to nickel or titanium
- Subject has known hypersensitivity to contrast that cannot be adequately premedicated
- Female subject who is breast feeding or is pregnant and planning to become pregnant within the study period
- Subject is participating in another investigational drug or device study that has not reached its primary endpoint or subject intends to participate in another investigational device clinical trial within 12 months after index procedure
- Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis
- Subject has oxygen-dependent chronic obstructive pulmonary disease
- Subject has documented severe liver disease
- Subject has Hgb <8 g/dL, platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3
- Subject has any evidence of intracardiac thrombus
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032
Montefiore Medical Center
The Bronx, New York, 10467
Tucson Medical Center Healthcare
Tucson, Arizona, 85712
About this study
Official title: A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation: (Millipede Feasibility Study)
To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation
Read the detailed description
The Millipede Feasibility Study is a prospective, open-label, single-arm study to assess the safety and feasibility/performance of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation. The study will include subjects with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) despite guideline directed medical therapy in whom the local hearth team determines that surgery is not an option for mitral valve repair. Clinical follow-up will be required in hospital, 30 days, 90 days, 6 months, 12 months, and then annually through 5 years post-procedure. Subjects who have any part of the Millipede Transcatheter Annuloplasty Ring System introduced into the body but who do not end up with an implant will be followed through 30 days.
- Being tested
- Millipede Transcatheter Annuloplasty Ring System (Millipede System)
- Keywords
- Functional Mitral Regurgitation, Mitral Repair
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Millipede Transcatheter Annuloplasty Ring System (Millipede System)Device
The Millipede Transcatheter Annuloplasty Ring System is a repair device used for treating mitral valve regurgitation (MR). The system consists of several components: a transcatheter annuloplasty ring (implant) which remains in the body and a delivery system and intracardiac echocardiography catheter (imaging device) used to deliver the implant to the mitral valve.
| Study group | Role | What they receive |
|---|---|---|
| Mitral Valve Repair | Experimental | All subjects will receive mitral valve repair using the Millipede System Receives: Device: Millipede Transcatheter Annuloplasty Ring System (Millipede System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Technical Success Endpoint
Technical Success (measured at exit from the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC ). All of the following must be present:
Absence of procedural mortality; and Successful access, delivery and retrieval of the device delivery system; and Successful deployment and correct positioning of the first intended device; and Freedom from emergency surgery or reintervention related to the device or access procedure.
Measured: Index procedure exit from the catheterization laboratory
Primary Safety Endpoint
The composite (aggregate) of the following implant-related and/or delivery-related serious adverse events (SAEs) at 30 days post index procedure (based on MVARC definitions and adjudicated by an independent clinical events committee). The unit of outcome measure is % (n/N):
- Mortality: all-cause
- Stroke: disabling and non-disabling; Bleeding: life-threatening based MVARC scale
- Major access site vascular complications
- Major cardiac structural complications due to access-related issues
- Acute kidney injury (AKI; ≤7 days post index procedure): based on the Acute Kidney Injury Network (AKIN) --System Stage 3 (including renal replacement therapy) or Stage 2
- Myocardial infarction (MI; periprocedural [≤48 hours] or spontaneous [>48 hours])
- Coronary ischemia requiring percutaneous coronary intervention (PCI) or coronary artery bypass graft
- Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
Measured: 30 days post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start13 Nov 2019
- Primary completion17 Dec 2021
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Regurgitation FunctionalStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Gooley, MBBS, PhD, Principal investigator, Monash HealthNicolas Van Mieghem, MD, PhD, Principal investigator, Erasmus Medical CenterSusheel K Kodali, MD, Principal investigator, New York-Presbyterian/Columbia University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147884
- Sponsor's protocol ID
- S2436
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2019
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation: (Millipede Feasibility Study)
- ClinicalTrials.gov ID
- NCT04147884
- Acronym / sponsor ID
- S2436
- Keywords
- Functional Mitral Regurgitation, Mitral Repair
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 1 Nov 2019 (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 evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation
Detailed description
The Millipede Feasibility Study is a prospective, open-label, single-arm study to assess the safety and feasibility/performance of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation. The study will include subjects with functional mitral regurgitation classified as moderate to severe (3+) or severe (4+) that are symptomatic (NYHA Class II-IV) despite guideline directed medical therapy in whom the local hearth team determines that surgery is not an option for mitral valve repair. Clinical follow-up will be required in hospital, 30 days, 90 days, 6 months, 12 months, and then annually through 5 years post-procedure. Subjects who have any part of the Millipede Transcatheter Annuloplasty Ring System introduced into the body but who do not end up with an implant will be followed through 30 days.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitral Valve Repair | Experimental | Device: Millipede Transcatheter Annuloplasty Ring System (Millipede System)All subjects will receive mitral valve repair using the Millipede System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is 18 years of age or older
- Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
- Subject has moderate to severe (3+) or severe (4+) functional mitral regurgitation confirmed by echocardiography core lab
- Subject is symptomatic (NYHA Class II-IV) despite guideline directed medical therapy, including CRT if indicated
- The local site heart team concurs that mitral valve surgery will not be offered as a first-line treatment option
Key exclusion criteria (28 listed)
- Subject has severe calcification of the mitral annulus or leaflets or other anatomic features that make the subject unsuitable for annuloplasty with the Millipede System in the judgment of the treating physician or subject does not have suitable mitral annular diameter (determined by CT) as per the Instructions for Use
- Transfemoral venous and transseptal access determined not to be feasible
- Subject is on the waiting list for a transplant or has had a prior heart transplant
- Subject has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 30 days prior to study enrollment
- Subject has had any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to study enrollment
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 |
|---|---|---|
| Millipede Transcatheter Annuloplasty Ring System (Millipede System)The Millipede Transcatheter Annuloplasty Ring System is a repair device used for treating mitral valve regurgitation (MR). The system consists of several components: a transcatheter annuloplasty ring (implant) which remains in the body and a delivery system and intracardiac echocardiography catheter (imaging device) used to deliver the implant to the mitral valve. | Device | Mitral Valve Repair |
Primary outcome
Primary Technical Success Endpoint
Time frame: Index procedure exit from the catheterization laboratory
Technical Success (measured at exit from the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC ). All of the following must be present: Absence of procedural mortality; and Successful access, delivery and retrieval of the device delivery system; and Successful deployment and correct positioning of the first intended device; and Freedom from emergency surgery or reintervention related to the device or access procedure.
Primary Safety Endpoint
Time frame: 30 days post index procedure
The composite (aggregate) of the following implant-related and/or delivery-related serious adverse events (SAEs) at 30 days post index procedure (based on MVARC definitions and adjudicated by an independent clinical events committee). The unit of outcome measure is % (n/N): * Mortality: all-cause * Stroke: disabling and non-disabling; Bleeding: life-threatening based MVARC scale * Major access site vascular complications * Major cardiac structural complications due to access-related issues * Acute kidney injury (AKI; ≤7 days post index procedure): based on the Acute Kidney Injury Network (AKIN) --System Stage 3 (including renal replacement therapy) or Stage 2 * Myocardial infarction (MI; periprocedural [≤48 hours] or spontaneous [>48 hours]) * Coronary ischemia requiring percutaneous coronary intervention (PCI) or coronary artery bypass graft * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided. The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)
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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.
Robert Gooley, MBBS, PhD principal investigator
Monash Health
Nicolas Van Mieghem, MD, PhD principal investigator
Erasmus Medical Center
Susheel K Kodali, MD principal investigator
New York-Presbyterian/Columbia University Medical Center
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Millipede Transcatheter Annuloplasty Ring System (Millipede System) in people with Mitral Regurgitation Functional and Mitral Valve Disease, run by Boston Scientific Corporation at 4 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 7 inclusion and 28 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: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Primary Technical Success Endpoint (time frame: Index procedure exit from the catheterization laboratory). 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 23 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.