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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04147884
Recruitment Status : Recruiting
First Posted : November 1, 2019
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE October 30, 2019
First Posted Date  ICMJE November 1, 2019
Last Update Posted Date September 17, 2020
Actual Study Start Date  ICMJE November 13, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2019)
Technical Success [ Time Frame: Discharge or 7 days post-procedure, whichever comes ]
Technical Success is defined as successful delivery of the device in the correct anatomical position and withdrawal of the delivery system without conversion to surgery or in-hospital mortality
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Official Title  ICMJE A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation: (Millipede Feasibility Study)
Brief Summary To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System (Millipede System) in patients with functional mitral regurgitation
Detailed Description The Millipede Feasibility Study is a prospective, open-label, single-arm study to assess the safety and feasibility of the Millipede Transcatheter Annuloplasty Ring System in patients 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Mitral Regurgitation Functional
  • Mitral Valve Disease
  • Cardiovascular Diseases
Intervention  ICMJE Device: 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.
Study Arms  ICMJE Experimental: Mitral Valve Repair
All subjects will receive mitral valve repair using the Millipede System
Intervention: Device: Millipede Transcatheter Annuloplasty Ring System (Millipede System)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Subject is symptomatic (NYHA Class II-IV) despite guideline directed medical therapy, including CRT if indicated
  • The local site heart team concurs that surgery will not be offered as a treatment option
  • Subject is a candidate for annuloplasty based on the criteria below as assessed by the investigative site:

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, mitral annular diameter >43 mm in any dimension or other anatomic features which make the patient unsuitable for annuloplasty with the Millipede System in the judgment of the treating physician
  • 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 requiring dialysis
  • Subject has a life expectancy less than 12 months
  • Subjects in whom trans-esophageal ECHO/Doppler is contraindicated or in which mitral regurgitation is not measurable by Transthoracic Echocardiography (TTE)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Blessie Concepcion 800-876-9960 Blessie.Concepcion@bsci.com
Contact: Alison Osattin 800-876-9960 alison.osattin@bsci.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04147884
Other Study ID Numbers  ICMJE S2436
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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)
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Gooley, MBBS Monash Health
PRS Account Boston Scientific Corporation
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP