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NCT02673697 · ClinicalTrials.gov registry record · NA

Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement

A NA study, sponsored by Corcym S.r.l.

Terminated
Registry status
NA
Development phase
914
Enrollment target

NCT02673697 is a NA study that was terminated before completion, run by Corcym S.r.l. The registered enrollment target is 914 participants.

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The verdict

NCT02673697, a NA study, was terminated before completion, sponsored by Corcym S.r.l.

TERMINATED
Registry status
NA
Development phase
914 participants
Enrollment target

Study Summary

Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively. The trial will enroll up to 1234 subjects, but accrual may stop earlier at approximately 900 or 1050 subjects These subjects will be enrolled at approximately 60 worldwide investigational sites where the device is commercially available The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.

Interventions

  • DEVICE Perceval valve
  • DEVICE other stented biological valve

Trial Details

FieldValue
Enrollment Target 914 participants
Start Date 2016-03-22
Est. Completion 2020-07-31
Phase NA

Sponsor

Corcym S.r.l

4 total trials

What the Registry Record Tells You About NCT02673697

The ClinicalTrials.gov registry entry for NCT02673697 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 914 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corcym S.r.l, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Perceval valve is the first listed.

NCT02673697 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02673697 about?

NCT02673697 is a clinical study titled "Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement". Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively. The trial will enroll up to 1234 subjects, but accrual may stop earlier at approximately 900 o...

What is the current status of trial NCT02673697?

This trial is currently terminated. It is a NA study. The enrollment target is 914 participants. The study started on 2016-03-22. Estimated completion is 2020-07-31.

What interventions are being tested in trial NCT02673697?

The interventions under investigation include: Perceval valve (DEVICE), other stented biological valve (DEVICE).

Who is sponsoring clinical trial NCT02673697?

This trial is sponsored by Corcym S.r.l, which has 4 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.