A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients with Functional Mitral Regurgitatio
- Conditions
- repair of the mitral valve - a backflow of blood within the heart due to the failure of the mitral valve to close properly10046973
- Registration Number
- NL-OMON50054
- Lead Sponsor
- Boston Scientific Cooperation International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
IC1: Subject is 18 Years of age or older
IC2: Subject (or legal guardian) understands the trial requirements and the
treatment procedures and provides informed consent before any trial -specific
tests or procedures are performed
IC3: Subject has moderate to severe (3+) or severe (4+) functional mitral
regurgitation(a) confirmed by the echocardiography core lab.
IC4: Subject is symptomatic (NYHA Class II-IV) despite guidelines directed
medical therapy, including CRT if indicated
IC5. The local site heart team concurs that mitral valve surgery will not be
offered as a first-line treatment option
IC6. Subject is a candidate for annuloplasty based on the criteria below as
assessed by the investigative site (and confirmed by the Case Review
Committee):
• LVEF >= 25%
• LVEDD <= 65 mm
• Coaptation distance (i.e. tenting height) < 10 mm
• Absence of posterior wall aneurysm
(a): Assessment per the American Society of Echocardiography mitral
regurgitation grading criteria [24, 25]
Abbreviations: CRT=cardiac resynchronization therapy; LVEDD=left ventricular
end diastolic diameter; LVEF=left ventricular ejection fraction; NYHA=New York
Heart Association
EC1. Subject has severe calcification of the mitral annulus or leaflets, other
anatomic features that makes the patient 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 computed tomography) as
per the Instructions For Use).
EC2. Transfemoral venous and transseptal access determined not to be feasible
EC3. Subject is on the waiting list for a transplant or has had a prior heart
transplant
EC4. Subject has had a cerebrovascular accident (CVA) or transient ischemic
attack (TIA) within 30 days prior to study enrollment
EC5. Subject has had any percutaneous coronary, carotid, or other endovascular
intervention within 30 days prior to study enrollment
EC6. Subject has had carotid surgery within 30 days prior to study enrollment
EC7. Subject has had any open coronary or vascular surgery (other than carotid
surgery) within 3 months prior to study enrollment
EC8. Subject has had a cardiac resynchronization therapy (CRT) device
implantation within 3 months prior to study enrollment
EC9. Subject has untreated clinically significant coronary artery disease
requiring revascularization
EC10. Any planned cardiac surgery within the next 12 months
EC11. Need for emergent or urgent surgery for any reason
EC12. Subject has severe aortic valve stenosis and/or aortic valve
regurgitation
EC13. Subject has physical evidence of right-sided congestive heart failure
(CHF) plus echocardiographic evidence of moderate or severe right ventricular
dysfunction and/or severe tricuspid valve regurgitation
EC14. Subject has the presence of prosthetic heart valve in any position
EC15. Subject has renal insufficiency (eGFR <20 mL/min) and is not on dialysis
EC16. Subject has a life expectancy less than 12 months
EC17. Subjects in whom trans-esophageal ECHO/Doppler is contraindicated or in
which mitral regurgitation is not measurable by transthoracic echocardiogram
(TTE)
EC18: Subject has a prior history of atrial septal defect (ASD) closure or
patent foramen ovale (PFO) closure.
EC19: Subject has a fixed pulmonary artery systolic pressure >70 mmHg.
EC20: Subject has known hypersensitivity or contraindication to protocol
required procedural or post procedural medication (e.g., anticoagulation
therapy) or hypersensitivity to nickel or titanium
EC21. Subject has known hypersensitivity to contrast that cannot be adequately
premedicated
EC22. Female subject who is breast feeding or pregnant or planning to become
pregnant within the study period.
EC23. 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.
EC24. Subject has a history of endocarditis within 6 months of index procedure
or evidence of an active systemic infection or sepsis.
EC25. Subject has oxygen-dependent chronic obstructive pulmonary disease.
EC26. Subject has documented severe liver disease.
EC27. 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.
EC28. Subject has any evidence of intracardiac thrombus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary safety endpoint, measured in-hospital, is technical success:<br /><br>defined as successful delivery of the device in the correct anatomical position<br /><br>and withdrawal of the delivery system without conversion to surgery or<br /><br>in-hospital mortality.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Additional endpoints include clinical measures, functional measures, imaging<br /><br>parameters and device performance. For detailed list of endpoints, please refer<br /><br>to section 6.2 of the Protocol</p><br>