Autopsy report · NCT01810679

Perceval S Aortic Heart Valve Study- North America

“FDA approval”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month before it started.
• Ran for about 5 years before it stopped.
• 355 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Na

Sponsor

Sorin Group USA, Inc.

Sponsor type

Industry

Conditions

Aortic Valve Stenosis; Aortic Valve Stenosis With Insufficiency; Regurgitation, Aortic Valve; Aortic Valve Incompetence

Interventions

Perceval S Aortic Heart Valve

Participants

355

Sites

21

Countries

United States

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  “Study Drug was FDA approved Summer 2021” (72% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.