Edwards Lifesciences
This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair procedure using the PASCAL Precision system.
This is a prospectively designed, retrospective non-randomized cohort study to measure the 2-year effectiveness of the PASCAL Precision Transcatheter Valve Repair system ("PASCAL Precision system") for the treatment of at least severe tricuspid regurgitation in the real world. This study will evaluate patients treated with the PASCAL Precision system who have at least severe Tricuspid Regurgitation as compared to Medicare eligible untreated patients. Analysis will be completed using a large, de-identified, claims and electronic health record (EHR) database and supplemented with registry and o…
Inclusion Criteria: * Medicare eligible patients, 65 years old or older * With at least severe Tricuspid Regurgitation who have either received PASCAL Precision system or been managed medically with no transcatheter or surgical tricuspid valve intervention Exclusion Criteria: * Patients not eligible for Medicare (i.e., under 65 years old) * Patients with less than severe Tricuspid Regurgitation * Patients who have received a transcatheter or surgical intervention other than PASCAL Precision system
Patients 65 years old or older with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair with the PASCAL Precision system.
Patients 65 years old or older with at least severe Tricuspid Regurgitation who did not receive any transcatheter or surgical tricuspid valve intervention.
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