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.
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
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
Medicare eligible real-world patients with severe tricuspid regurgitation
Cohort
Retrospective
PASCAL Precision system Treated
DevicePatients 65 years old or older with at least severe Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair with the PASCAL Precision system.
Medicare Eligible Untreated Patients
Other interventionPatients 65 years old or older with at least severe Tricuspid Regurgitation who did not receive any transcatheter or surgical tricuspid valve intervention.
Composite (All-Cause Death or Heart Failure Hospitalization)
Time to death or heart failure hospitalization after time zero
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This trial is not recruiting at the moment. You can still explore other options:
