Mitral Valve Replacement
Conditions
Brief summary
This study is to collect preliminary chronic information on performance and safety of the ReValve System.
Interventions
DEVICEReValve System
Mitral Valve Replacement Device
Sponsors
ReValve Solutions Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Symptomatic functional and/or degenerative MR (≥2+) due to ischemic and non-ischemic cardiomyopathy etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 60 days and transesophageal echocardiogram (TEE) obtained within 90 days prior to subject registration, with MR severity based principally on the TTE study. * New York Heart Association (NYHA) Functional Class II, III or ambulatory IV. * 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 CT. * Age greater than 18 years. * Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject consent. Key
Exclusion criteria
* Untreated clinically significant coronary artery disease requiring revascularization. * Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months. * Status 1 heart transplant or prior orthotopic heart transplantation. * Cerebrovascular accident within 30 days prior to subject's consent. * Pregnant or planning pregnancy within next 12 months. * Currently participating in an investigational drug or another device study. * Evidence of LV or LA thrombus, vegetation or mass * Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Procedure | The Technical Success, is defined as the successful delivery of the ReValve Palmetto Valve and withdrawal of the delivery system |
Countries
Brazil
Outcome results
None listed