Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX

Last updated: April 7, 2020
Sponsor: Edwards Lifesciences
Overall Status: Completed

Phase

N/A

Condition

Cardiac Disease

Hypercholesterolemia

Thrombosis

Treatment

Implantation of CEP Magna Ease Model 3300TFX

Clinical Study ID

NCT01171625
2007-08
  • Ages > 18
  • All Genders

Study Summary

The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The patient requires, as indicated in the preoperative evaluation, a replacementaortic valve.

  2. The patient is an average or better operative risk.

  3. The patient is geographically stable and agrees to attend follow-up assessments at thehospital of surgical services for at least 8 years.

  4. The patient is 18 years or older.

  5. The patient has signed and dated the subject informed consent form prior to surgery.

Exclusion

Exclusion Criteria:

  1. The patient has any known non-cardiac life-threatening disease, which will limit thepatient's life expectancy below 1 year.

  2. The patient presents with active endocarditis within the last 3 months.

  3. The patient has an abnormal calcium metabolism (e.g., chronic renal failure,hyperparathyroidism).

  4. The patient has an aneurismal aortic degenerative condition (e.g., cystic medialnecrosis, Marfan's syndrome).

  5. The patient is pregnant or lactating.

  6. The patient is an intravenous drug abuser.

  7. The patient is currently a prison inmate.

  8. The patient is currently participating in a study of an investigational drug ordevice.

  9. The patient requires replacement of a native or prosthetic mitral, tricuspid orpulmonic valve.

  10. The patient requires a repair of the mitral or tricuspid valve with the use of anannuloplasty device.

  11. The patient was previously enrolled in the study.

  12. The patient had a prior mitral, tricuspid or pulmonic valve surgery, which includedimplantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring thatwill remain in situ.

Study Design

Total Participants: 283
Treatment Group(s): 1
Primary Treatment: Implantation of CEP Magna Ease Model 3300TFX
Phase:
Study Start date:
October 01, 2007
Estimated Completion Date:
September 30, 2018

Study Description

This is a prospective, single-arm, multi-center, interventional study to be conducted in the US and outside the US (OUS). This study will enroll a minimum of 225 patients implanted with the study valve in order to achieve 101 aortic valve replacement subjects each followed for a minimum of 8 years. The study will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged or malfunctioning natural or prosthetic aortic valve. Patients will be followed and assessed after implant at discharge, 6 months, one year, and annually for a minimum of 8 years.

Connect with a study center

  • Universitatslinik fur Chirurgie

    Anichstr. 35, Innsbruck 6020
    Austria

    Site Not Available

  • Universitatslinik fur Chirurgie

    Innsbruck, 6020
    Austria

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • St. Paul's Hospital

    Vancouver, V6Z 1Y6
    Canada

    Site Not Available

  • Liknik fur Herz und BefaBchirurgie Im Deuschen Herzzentrum

    Munich, Lazarettstr 36
    Germany

    Site Not Available

  • Klinik fur Herz-, Thorax-, Transplantations- und Gefabchirurgie

    Hannover, D-30625
    Germany

    Site Not Available

  • Hospital Peutra de Hierro

    San Martin de Porres 4, Madrid CP-28035
    Spain

    Site Not Available

  • Papworth Hospital NHS foundation Trust

    Papworth Everard, Cambridge CV23 3RE
    United Kingdom

    Site Not Available

  • Blackpool Victoria Hospital

    Blackpool, Lancashire FY8 8NR
    United Kingdom

    Site Not Available

  • University of Arizona

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Mercy General Hospital

    Sacramento, California 95819
    United States

    Site Not Available

  • Cooper University Hospital

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Morristown Memorial Hospital

    Morristown, New Jersey 09762
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Providence Heart & Vascular Institute

    Portland, Oregon 97225
    United States

    Site Not Available

  • St. Marks Hospital

    Salt Lake City, Utah 84124
    United States

    Site Not Available

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