AVJ-514 Japan Trial

Inclusion Criteria

Subjects must meet all of the following inclusion criteria:

• Age 20 years or older.
• Symptomatic moderate-to-severe (3+) or severe MR (4+) chronic Degenerative Mitral Regurgitation (DMR) or Functional Mitral Regurgitation (FMR) determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within180 days prior to subject registration, with MR severity based principally on the TTE study and confirmed by the Echocardiography Core Laboratory (ECL). The ECL may request a TEE.
• Left Ventricular Ejection Fraction (LVEF) is ≥ 30％ within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI). Note: The method must provide a quantitative readout (not a visual assessment).
• New York Heart Association (NYHA) classification is class II, class III, or ambulatory class IV.
• Subject is deemed difficult for mitral valve surgery due to either Society of Thoracic Surgery (STS) surgical mortality risk for mitral valve replacement of ≥ 8% OR due to the presence of one of the following risk factors:
• Porcelain aorta or mobile ascending aortic atheroma
• Post-radiation mediastinum
• Previous mediastinitis
• Functional MR with LVEF 70% by ultrasound)
• Any cardiac surgery within 180 days prior to registration
• Percutaneous coronary intervention (PCI) within the last 30 days prior to registration
• Implant of Cardiac Resynchronization Therapy (CRT), Cardiac Resynchronization Therapy with Cardioverter Defibrillator (CRT-D) pacemaker or Implantable Cardioverter Defibrillator (ICD)within the last 30 days prior to registration.
• Transcatheter aortic valve replacement (TAVR) within the last 30 days prior to registration.
• Severe tricuspid regurgitation or aortic valve disease requiring surgical treatment.
• In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or presence of ipsilateral deep vein thrombosis (DVT).
• Hemodynamic instability defined as systolic pressure < 90 mmHg without afterload reduction drug or cardiogenic shock or intra-aortic balloon pump.
• History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
• Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll at least 14 days after discontinuation of antibiotics). Patients must be free from infection prior to treatment. Any required dental work should be completed a minimum of 21 days prior to treatment.
• Intravenous drug abuse or suspected inability to adhere to follow-up.
• Patients in whom TEE is contraindicated.
• A known hypersensitivity or contraindication to study or procedure medications which cannot be adequately managed medically.
• In the judgment of the Investigator, subjects 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.
• Subject intends to participate in any other investigational or invasive clinical study within a period of 1 year following the AVJ-514 procedure.
• 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).
• In the opinion of the investigator or designee, subject is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
• In the opinion of the anesthesiologist, general anesthesia is contraindicated.
• Pregnant or planning pregnancy within next 1 year.