Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

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NCT03706833

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

Phase

Not applicable

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

1,247estimated

Sites

Countries

Canada, Germany, Switzerland +1

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

2018-11-30

actual

When the study began enrolling

Primary completion

2026-06-30

estimated

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

Study completion

2031-06-30

estimated

The whole study's end, after follow-up

First posted

2018-10-16

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-08

actual

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

What it studies

Conditions

Degenerative Mitral Valve Disease
Mitral Regurgitation
Mitral Insufficiency
Functional Mitral Regurgitation

Interventions

Device: Edwards PASCAL System — also filed as Transcatheter Mitral Valve repair (TMVr)
Device: Abbott Mitraclip System — also filed as Transcatheter Mitral Valve repair (TMVr)

Primary outcomes

what the primary-completion date above is the date OF

PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs).

measured 30 days.

PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort.

measured 6 months

PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only.

measured From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up

Publications

PMID 42233921 — linked by the registry
PMID 38099912 — linked by the registry
PMID 36725171 — linked by the registry
PMID 36121247 — 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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