The PALMETTO Study

This study will evaluate the safety and performance of the ReValve System for the treatment of patients with clinically significant symptomatic primary orsecondary mitral regurgitation who are at high, but not prohibitive, surgical risk for mitral valvesurgery and, who are deemed anatomically or technically unsuitable for transcatheter edge-to-edgerepair (TEER) by the multidisciplinary heart team (MDHT).

• ReValve System (Device): ReValve System Mitral Valve Replacement Procedure

Primary outcomes

• Primary Efficacy Endpoint [30 Days]: Procedural Success according to MVARC criteria All of the following must be present: Device Success: Absence of procedural mortality or stroke; proper placement and positioning of the device; freedom from unplanned surgical/interventional procedures related to device/access; and continued intended safety and performance. Absence of major device or procedure related serious adverse events: Death; stroke; life-threatening bleeding (MVARC scale); major vascular complications; major cardiac structural complications; Stage 2 or 3 acute kidney injury (includes new dialysis); myocardial infarction or coronary ischemia requiring PCI or CABG; severe hypotension, heart failure, or respiratory failure requiring IV pressors, mechanical heart failure treatments, or intubation ≥48 h; or any study valve dysfunction, migration, or thrombosis requiring surgery or repeat intervention.

Sex: All, ages: 18 Years to any

Key Inclusion Criteria:

* Age greater than 18 years
* Mitral regurgitation ≥ 3+ documented by echo
* Symptomatic New York Heart Association (NYHA) Functional Class II-IVa despite optimal medical therapy for at least 30 days

Key Exclusion Criteria:

* Severe tricuspid valve pathology with > moderate tricuspid regurgitation.
* Greater than moderate RV dysfunction
* Significant aortic valve regurgitation greater than moderate and or stenosis greater than moderate
* Prior cardiac surgery or intervention, within 6 months that would prohibit the implant of the Palmetto Valve as determined by the screening committee
* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
* Pregnant or planning pregnancy within next 12 months
* Currently participating in an investigational drug or another device study
* Known hypersensitivity or contraindication to iodinated contrast media, aspirin, heparin, bivalirudin, or warfarin, where no adequate alternative therapy is available to support the required intraprocedural anticoagulation and the minimum six-month post-procedural anticoagulation regimen
* Pre-existing hemodynamically significant pericardial effusion requiring intervention at the discretion of the multidisciplinary heart team