AVJ-514 Japan Trial

Exclusion Criteria

• •1. LVEF is \< 30%
• •2. Leaflet anatomy which may preclude AVJ-514 implantation, proper positioning on the leaflets or sufficient reduction in MR by the AVJ-514 based. This evaluation is based on TEE evaluation of the mitral valve within 180 days prior to subject registration and includes:
• •* Insufficient mobile leaflet available for grasping with the AVJ-514 device
• •* Lack of both primary and secondary chordal support in the grasping area
• •* Evidence of significant calcification in the grasping area
• •* Presence of a significant cleft in the grasping area
• •3. Life expectancy \< 1 year due to associated non-cardiac co-morbid conditions
• •4. Need for emergent or urgent surgery for any reason
• •5. Prior open heart mitral valve leaflet surgery or any currently implanted prosthetic mitral valve or any prior transcatheter mitral valve procedure.
• •6. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• •7. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated).
• •8. Untreated clinically significant coronary artery disease requiring revascularization or significant myocardial ischemia or evidence of an acute myocardial infarction in the prior 90 days of registration.
• •9. Cerebrovascular accident within 180 days prior to registration
• •10. Severe symptomatic carotid stenosis (\> 70% by ultrasound)
• •11. Any cardiac surgery within 180 days prior to registration
• •12. Percutaneous coronary intervention (PCI) within the last 30 days prior to registration
• •13. 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.
• •14. Transcatheter aortic valve replacement (TAVR) within the last 30 days prior to registration.
• •15. Severe tricuspid regurgitation or aortic valve disease requiring surgical treatment.
• •16. In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or presence of ipsilateral deep vein thrombosis (DVT).
• •17. Hemodynamic instability defined as systolic pressure \< 90 mmHg without afterload reduction drug or cardiogenic shock or intra-aortic balloon pump.
• •18. History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
• •19. 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.
• •20. Intravenous drug abuse or suspected inability to adhere to follow-up.
• •21. Patients in whom TEE is contraindicated.
• •22. A known hypersensitivity or contraindication to study or procedure medications which cannot be adequately managed medically.
• •23. 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.
• •24. Subject intends to participate in any other investigational or invasive clinical study within a period of 1 year following the AVJ-514 procedure.
• •25. 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).
• •26. 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.
• •27. In the opinion of the anesthesiologist, general anesthesia is contraindicated.
• •28. Pregnant or planning pregnancy within next 1 year.