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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04147884




Registration number
NCT04147884
Ethics application status
Date submitted
30/10/2019
Date registered
1/11/2019

Titles & IDs
Public title
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Scientific 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)
Secondary ID [1] 0 0
S2436
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitral Regurgitation Functional 0 0
Mitral Valve Disease 0 0
Cardiovascular Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Millipede Transcatheter Annuloplasty Ring System (Millipede System)

Experimental: Mitral Valve Repair - All subjects will receive mitral valve repair using the Millipede System


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Technical Success Endpoint
Timepoint [1] 0 0
Index procedure exit from the catheterization laboratory
Primary outcome [2] 0 0
Primary Safety Endpoint
Timepoint [2] 0 0
30 days post index procedure

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
New York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Gooley, MBBS, PhD
Address 0 0
Monash Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
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)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04147884