The CLASP III TR CED Study

NCT07859709 — Not yet recruiting, 2350 participants, Edwards Lifesciences

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Edwards PASCAL Transcatheter Tricuspid Valve Repair System Coverage With Evidence Development Study (The CLASP III TR CED Study)

Registry	NCT07859709
Status	Not yet recruiting
Study type	Observational
Enrollment	2350 (Estimated)
Sponsor	Edwards Lifesciences (Industry)
Conditions	Tricuspid Regurgitation, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Tricuspid Valve Insufficiency
Interventions	PASCAL Precision system Treated, Medicare Eligible Untreated Patients (Device, other)
Dates	start 2026-10-15 (estimated), primary completion 2030-12-31 (estimated), completion 2033-10-31 (estimated), first posted 2026-10-06, last updated 2026-10-06
Locations	1 site in United States

-Summary

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.

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+Detailed description

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 other claims data.

The primary outcome will also be assessed in various pre-defined subgroups.

+Arms and interventions

Arm	Type	Interventions	Description
PASCAL Precision system Treated		Device: PASCAL Precision system Treated	Patients 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: Medicare Eligible Untreated Patients	Patients 65 years old or older with at least severe Tricuspid Regurgitation who did not receive any transcatheter or surgical tricuspid valve intervention.

PASCAL Precision system Treated (Device): Patients 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): Patients 65 years old or older with at least severe Tricuspid Regurgitation who did not receive any transcatheter or surgical tricuspid valve intervention.

+Outcome measures

Primary outcomes

Composite (All-Cause Death or Heart Failure Hospitalization) [2 years]: Time to death or heart failure hospitalization after time zero

+Eligibility

Sex: All, ages: 65 Years to any

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

+Locations (1)

Facility	City	Country	Status
Edwards Lifesciences	Irvine, California	United States