Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Conditions

• Tricuspid Regurgitation
• Tricuspid Valve Disease
• Tricuspid Valve Insufficiency

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Edwards PASCAL System — DEVICE
  Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
• Optimal Medical Therapy — DRUG
  Optimal Medical Therapy alone in patients with tricuspid regurgitation
• Edwards PASCAL System — DEVICE
  Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT
• Edwards PASCAL System — DEVICE
  Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Study Details

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

Key Dates

Start date

Dec 11, 2019

Status verified

May 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2031

Study Design

Enrollment

1,270 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Edwards PASCAL System & OMT
  Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
• Active Comparator: Optimal Medical Therapy (OMT)
  Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
• Experimental: Single-Arm Registry
  Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization
• Experimental: Continued Access Study
  Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Primary Outcome Measure

Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score) [ Time Frame: 6 months ]

Central Contacts

• Edwards TMTT Clinical Affairs
  (949) 250-2500
  [email protected]

Locations (73)

Find similar trials in Phoenix, AZ

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