MitrAl ValvE RepaIr Clinical Trial (MAVERIC Trial) - United States (MAVERIC US)

This is an interventional treatment trial for Mitral Valve Insufficiency Read More

Inclusion Criteria:

Candidates must meet ALL of the following criteria to be enrolled in the study.

• Is ambulatory, able and willing to comply with the study protocol and has provided written informed consent
• Age 21-85, inclusive
• Trans-septal catheterization is determined to be feasible by the treating physician
• NYHA class II-IV heart failure of any etiology
• Symptomatic with MR grade ≥ 2+
• LVEF < 40%
• LVEDD > 50 mm and ≤ 75 mm
• No anticipated change in patient's cardiac medication regimen anticipated throughout the course of the study.
• In the opinion of the investigator and heart surgery team, the patient is not an appropriate candidate for surgery, and the use of the ARTO System is technically feasible

Exclusion Criteria:

Candidates will be excluded from enrollment in the study if ANY of the following conditions apply.

• In the opinion of the Investigator, the femoral vein and internal jugular vein cannot accommodate a 16 F catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral DVT is present
• Significant structural abnormality of the mitral valve (e.g., flail, prolapse, leaflet calcification)
• Significant mitral annular calcification
• Hemodynamic instability (systolic pressure < 90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump)
• Prior mitral valve surgery or valvuloplasty or any currently implanted prosthetic valve or VAD
• History of, or active, rheumatic heart disease
• History of Atrial Septal Defects (ASD), whether repaired or not
• History of previously repaired PFO or PFO associated with clinical symptoms (e.g., cerebral ischemia) within 6 months of the planned investigational procedure
• In the opinion of the investigator, an atrial septal aneurysm is present that may interfere with transseptal crossing
• Serum creatinine > 2.5 mg/dL or dialysis dependent
• No access to coronary sinus and/or great cardiac vein
• Platelet count < 100 x 103 cells/mm3
• Evidence of active infection (fever with temperature > 38°C and/or WBC > 15,000) or endocarditis
• Echocardiographic evidence of mass intracardiac thrombus
• Patients on prescribed dual antiplatelet therapy (asprin + any P2Y12 inhibitor) that cannot be discontinued.
• Percutaneous coronary intervention or surgery anticipated within the 6 month follow up period following the investigational procedure
• Biventricular pacing initiated or anticipated within 6 months of the planned investigational procedure
• Evidence of an acute myocardial infarction within 12 weeks of the planned investigational procedure
• Stroke or TIA within 6 months of the planned investigational procedure
• GI bleeding within 6 months of the planned investigational procedure
• Intravenous drug abuse or suspected inability to adhere to follow-up
• Patients in whom TTE, TEE or ICE is contraindicated
• Contraindication to CT scan
• A known hypersensitivity or contraindication to study or procedure medications (specifically aspirin, clopidogrel and heparin) that cannot be adequately managed medically
• A known allergy or hypersensitivity to nickel
• A known need for any other cardiac surgery including surgery for coronary artery disease, atrial fibrillation, pulmonic, aortic or tricuspid valve disease
• In the judgment of the Investigator, patients in whom the presence of a permanent pacemaker or pacing leads would interfere with placement of the test device or the placement of the test device would disrupt the leads
• Irreversible bleeding disorder, history of bleeding diathesis or coagulopathy or refuses blood transfusion
• Evidence of disease or condition expected to compromise survival (< 1 year) or ability to complete follow-up assessments
• Pregnant or breastfeeding women
• Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. [Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials]
• Patient not a candidate for emergent surgical bailout in case of need