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

NCT04147884 | Active Not Recruiting DMC FDA Device

• 1 other identifier: S2436
• Study Type: interventional
• Target: 4
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Mitral Regurgitation Functional; Mitral Valve Disease; Cardiovascular Diseases

Keywords

Functional Mitral Regurgitation; Mitral Repair

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  30 days post index procedure

Study Arms (1)

Mitral Valve Repair

EXPERIMENTAL

All subjects will receive mitral valve repair using the Millipede System

Device: Millipede Transcatheter Annuloplasty Ring System (Millipede System)

Interventions

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.

Mitral Valve Repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (4)

Tucson Medical Center Healthcare

Tucson, Arizona, 85712, United States

Location

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Robert Gooley, MBBS, PhD

  Monash Health

  PRINCIPAL INVESTIGATOR

• Nicolas Van Mieghem, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Susheel K Kodali, MD

  New York-Presbyterian/Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: November 13, 2019
• Primary Completion: December 17, 2021
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (3); AU (1)