A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation: (Millipede Feasibility Study)
Overview
- Phase
- Not Applicable
- Intervention
- Millipede Transcatheter Annuloplasty Ring System (Millipede System)
- Conditions
- Mitral Regurgitation Functional
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 4
- Locations
- 8
- Primary Endpoint
- Primary Technical Success Endpoint
- Status
- Active, not recruiting
- Last Updated
- 4 days ago
Overview
Brief Summary
To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Mitral Valve Repair
All subjects will receive mitral valve repair using the Millipede System
Intervention: Millipede Transcatheter Annuloplasty Ring System (Millipede System)
Outcomes
Primary Outcomes
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.
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