Overview
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in transcatheter mitral valve repair.
Description
The objectives of this clinical study are to collect data on the safety of the Edwards PASCAL Transcatheter Valve Repair System in transcatheter mitral valve repair and on the effectiveness of the Edwards PASCAL System in improving MR and improving functional status and quality of life in a post market setting.
Eligibility
Inclusion Criteria:
- Age greater than or equal to 18 years
- Patient is determined to require percutaneous reconstruction of an insufficient mitral valve (MR greater than or equal to 2+ ) by a Heart Team who assesses patient risk and anatomic suitability.
- Patient is eligible to receive the PASCAL device per the current approved indications for use.
- Minimum 6 minutes walk test of 150m. This criteria applies only to patients presenting with primarily functional mitral valve regurgitation.
- Patient is willing and able to attend all follow up visits and to perform all tests.
Exclusion Criteria:
- Patient in whom a transesophageal echocardiography is contraindicated or screening transesophageal echocardiography is unsuccessful
- Leaflet anatomy which may preclude PASCAL device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- LVEDD > 8.0 cm determined by transthoracic echocardiography within 60 days prior to submission
- Contraindication to transseptal catheterization
- Presence of an occluded or thrombosed Inferior vena cava filter that would interfere with the delivery catheter, or ipsilateral deep vein thrombosis is present.
- Mitral valve area (MVA) < 4.0 cm as measured by planimetry (If MVA by planimetry is not measurable, PHT measurement is acceptable)
- Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator