Twelve TMVR Implant: Implantation of the Twelve TMVR System -Apical

Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System: Implant of Intrepid valve -Transfemoral

PILOT

PILOT

EFS

EFS

PILOT

EFS

PILOT

PILOT

EFS

Data not collected for EFS participants

PILOT

EFS

STS-PROM= Society of Thoracic Surgeons Predictive Risk of Mortality

STS-PROM score is a tool developed by the Society of Thoracic Surgeons to estimate a patients risk of death after cardiac surgery. The model incorporates a range of factors such as patient demographics, comorbidities, physiological data and procedure information that influence a patient risk.

PILOT

STS-PROM= Society of Thoracic Surgeons Predictive Risk of Mortality

STS-PROM score is a tool developed by the Society of Thoracic Surgeons to estimate a patients risk of death after cardiac surgery. The model incorporates a range of factors such as patient demographics, comorbidities, physiological data and procedure information that influence a patient risk.

EFS

PILOT One subject had a serum creatinine level deemed below the plausible lower threshold by our medical expert (<0.4 mg/dL) and was therefore excluded from the analysis.

EFS

NYHA is measured by the patients physical activity limitations and places the patients in one of four classes.

NYHA Class I is measured by no limitations of physical activity. NYHA Class II is measured by slight limitations of physical activity. NYHA Class III is measured by marked limitation of physical activity. NYHA Class IV is measured by symptoms of heart failure at rest. Any physical activity causes discomfort.

PILOT

NYHA is measured by the patients physical activity limitations and places the patients in one of four classes.

NYHA Class I is measured by no limitations of physical activity. NYHA Class II is measured by slight limitations of physical activity. NYHA Class III is measured by marked limitation of physical activity. NYHA Class IV is measured by symptoms of heart failure at rest. Any physical activity causes discomfort.

EFS

PILOT

EFS

PILOT

EFS

Mitral Regurgitation is blood flowing backward through the mitral valve.

Primary Mitral Regurgitation is measured by a problem with the mitral valve apparatus itself.

Secondary Mitral regurgitation is measured by an enlarged or weakened left side of the heart that pulls the valve leaflets apart and prevents them from closing. The mitral valve structure is normal.

PILOT One subject did not have either Core lab nor Site reported MR Etiology

Mitral Regurgitation is blood flowing backward through the mitral valve.

Primary Mitral Regurgitation is measured by a problem with the mitral valve apparatus itself.

Secondary Mitral regurgitation is measured by an enlarged or weakened left side of the heart that pulls the valve leaflets apart and prevents them from closing. The mitral valve structure is normal.

EFS

PILOT

EFS

PILOT

Twelve TMVR Implant: Implantation of the Twelve TMVR System -Apical (N=95)

Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System: Implant of Intrepid valve -Transfemoral (N=33)