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PERIGON Pivotal Trial

NCT02088554 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1312

Last updated 2026-04-29

Study results available
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Summary

To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Model 400 aortic valve bioprosthesis

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medtronic Cardiac Surgery

    lead INDUSTRY

Principal Investigators

  • Joseph Sabik, MD · University Hospital Cleveland Medical Center (Not a recruiting site)

  • Prof. Dr. Robert Johannes Menno Klautz, MD · Leiden University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-12
Primary Completion
2023-04-17
Completion
2035-12-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02088554 on ClinicalTrials.gov