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

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NCT02744677 · readout ≤ 134 d

Sponsored by Edwards Lifesciences (industry) · EW — their whole pipeline →.

Phase

Not applicable

Status

Recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

108estimated

Sites

Country

United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2016-07-05

actual

When the study began enrolling

Primary completion

Dec 2026

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Jun 2031

estimated

The whole study's end, after follow-up

First posted

2016-04-20

estimated

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-23

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

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

Interventions

Device: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV
Device: SAPIEN 3 THV
Device: SAPIEN 3 Ultra RESILIA THV

Primary outcome

what the primary-completion date above is the date OF

THV dysfunction

measured 1 year

Publications

PMID 36608435 — cited as background
PMID 41884901 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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