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Status:

TERMINATED

Perceval S Aortic Heart Valve Study- North America

Lead Sponsor:

Sorin Group USA, Inc.

Conditions:

Aortic Valve Stenosis

Aortic Valve Stenosis With Insufficiency

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

To demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Detailed Description

This investigation is a prospective, non-randomized, multi-center trial of the PERCEVAL valve implanted in patients requiring aortic valve replacement. The study will be conducted in a maximum of 25 c...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Subjects of age \>= 18 years.
  • Subjects with aortic valve stenosis or steno-insufficiency.
  • The subject is willing to sign the informed consent.
  • The subject in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
  • The subject is located in a geographic location that will enable the subject to return to the study site for all follow-up examinations (i.e. geographically stable).
  • Subject will be available to the investigator(s) for postoperative follow-up beyond one year.
  • Exclusion criteria:
  • The subject has preexisting valve prosthesis or annuloplasty ring in the mitral, pulmonic or tricuspid position.
  • The subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.
  • The subject has a previously implanted PERCEVAL valve that requires replacement.
  • Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass.
  • The subject has active endocarditis.
  • Subjects with active myocarditis
  • The subject is or will be participating in a concomitant research study of an investigational product.
  • Subjects with aneurysmal dilation or dissection of the ascending aortic wall.
  • The subject is a minor, drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
  • The subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient.
  • Subjects with known hypersensitivity to nickel alloys.
  • The subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism.
  • The subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥30 days prior to the planned valve implant surgery.
  • Subject is known to be noncompliant or is unlikely to complete the study.
  • Subjects with an aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter, assessed by TTE, is \> 1.3.

Exclusion

    Key Trial Info

    Start Date :

    April 1 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2018

    Estimated Enrollment :

    355 Patients enrolled

    Trial Details

    Trial ID

    NCT01810679

    Start Date

    April 1 2013

    End Date

    April 1 2018

    Last Update

    November 16 2016

    Active Locations (21)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (21 locations)

    1

    East Alabama Medical Center

    Opelika, Alabama, United States, 36801

    2

    University of Arizona

    Tucson, Arizona, United States, 85724

    3

    University of Colorado Denver

    Aurora, Colorado, United States, 80045

    4

    St. Vincent's Medical Center

    Jacksonville, Florida, United States, 32204