COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Conditions

• Complex Congenital Heart Defect
• Dysfunctional RVOT Conduit
• Pulmonary Valve Degeneration
• Pulmonary Valve Insufficiency

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• SAPIEN 3/SAPIEN 3 Ultra RESILIA THV — DEVICE
  SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position
• SAPIEN 3 THV — DEVICE
  SAPIEN 3 THV in the pulmonic position
• SAPIEN 3 Ultra RESILIA THV — DEVICE
  SAPIEN 3 Ultra RESILIA THV in the pulmonic position

Study Details

This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

Key Dates

Start date

Jul 5, 2016

Status verified

Dec 2025

Primary completion

Dec 31, 2026

Completion

Jun 30, 2031

Study Design

Enrollment

108 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: TPVR - Main Cohort
  Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
• Experimental: TPVR - THV Registry
  Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR.
• Experimental: TPVR- S3UR Registry
  Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).

Primary Outcome Measure

THV dysfunction [ Time Frame: 1 year ]

Central Contacts

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

Locations (25)

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