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

March 18, 2024 updated by: Boston Scientific Corporation

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

Study Overview

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Tucson Medical Center Healthcare
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center/New York Presbyterian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mitral Valve Repair
All subjects will receive mitral valve repair using the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Index procedure exit from the catheterization laboratory
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
30 days post index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2019

Primary Completion (Actual)

December 17, 2021

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (Actual)

November 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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