A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation

Running, not enrolling · Not applicable

Conditions studied: Mitral Regurgitation Functional, Mitral Valve Disease, Cardiovascular Diseases

In brief

To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation

Key facts

Study ID: NCT04147884
Run by: Boston Scientific Corporation
People needed: 4
Starts: 2019-11-13
Expected to finish: 2026-11-01
Last updated by the study team: 2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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
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

Where it is running

Tucson Medical Center Healthcare — Tucson, Arizona, United States
Columbia University Medical Center/New York Presbyterian Hospital — New York, New York, United States
Montefiore Medical Center — The Bronx, New York, United States
Monash Health — Clayton, Victoria, Australia

Full record on ClinicalTrials.gov

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