The objective of this study is to evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in patients with functional mitral regurgitation.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary safety endpoint, measured in-hospital, is technical success:
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.
Secondary outcome
Additional endpoints include clinical measures, functional measures, imaging
parameters and device performance. For detailed list of endpoints, please refer
to section 6.2 of the Protocol
Background summary
The Millipede Annuloplasty Ring System is a novel transcatheter, fully
adjustable, complete annuloplasty repair device for the treatment of mitral
regurgitation. The device is designed to mimic a widely used surgical
intervention with a percutaneous therapy. As such, it potentially offers a less
invasive and safer treatment for mitral regurgitation in comparison to surgery.
Millipede conducted a series of acute and chronic animal studies to evaluate
the feasibility and safety of the Millipede System in support of initiating
early clinical studies.
These clinical studies demonstrated that the Millipede device can be safely
implanted in humans with a subsequent reduction in the mitral regurgitation
grade. The Millipede Transcatheter Annuloplasty Ring System IB contains a
detailed summary of these clinical studies.
Study objective
The objective of this study is to evaluate the feasibility and safety of the
Millipede Transcatheter Annuloplasty Ring System in patients with functional
mitral regurgitation.
Study design
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.
Intervention
Not applicable
Study burden and risks
Risk associated with Millipede system are listed in the Instructions For Use,
Investigator*s Brochure, Protocol and Informed Consent Form.
Additional risks may exist. Risks can be minimized through compliance with the
protocol, performing procedures in the appropriate hospital environment,
adherence to subject selection criteria, close monitoring of the subject*s
physiologic status during research procedures and/or follow-ups and by promptly
supplying BSC with all pertinent information required by this protocol.
Data will be monitored as they are submitted to sponsor. Qualified employees at
sponsor, or a designee under contract, will conduct monitoring visits at the
initiation of the study and at interim intervals described in the monitoring
plan throughout the course of the study to evaluate protocol compliance and
determine if there are any issues that could affect the safety or welfare of
any subject in the study.
Transcatheter mitral valve repair (TMVr) may offer certain advantages when
compared to surgical repair of the mitral valve. Known benefits of a minimally
invasive procedure and reduced risk related to open heart surgery may include
shorter overall hospital stay, reduced blood loss and more rapid recovery
Le Val Saint-Quentin 2 rue René Caudron
Voisins le Bretonneux, France 78960
FR
Le Val Saint-Quentin 2 rue René Caudron
Voisins le Bretonneux, France 78960
FR
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04147884 |
| CCMO | NL74260.078.20 |