Magna Mitral - 23mm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01312779
Recruitment Status : Active, not recruiting
First Posted : March 11, 2011
Last Update Posted : November 14, 2017
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
The purpose of this clinical study is to obtain human clinical data that demonstrates that the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is a safe and effective replacement heart valve.

Condition or disease Intervention/treatment Phase
Mitral Heart Valve Disease Device: Implantation of CEP Magna Mitral Model 7000TFX Not Applicable

Detailed Description:
This is a prospective, non-randomized, multi-site, descriptive study. A minimum of 15 and up to 20 subjects will be implanted at a minimum of 2 and up to 8 participating investigational sites within the US and internationally.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Size 23mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Study Start Date : March 2011
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
All subjects receive implant
Subjects serve as own control
Device: Implantation of CEP Magna Mitral Model 7000TFX
Heart valve surgery: CEP Magna Mitral Model 7000 TFX

Primary Outcome Measures :
  1. Mean effective orifice area at 1 year post implant [ Time Frame: Entire study period-5 years post implant ]
    Mean effective orifice area (EOA) at 1 year post-implant will be reported.

Secondary Outcome Measures :
  1. Number and percentage of subject in NYHA functional class I or II at 1 year post-implant. [ Time Frame: Entire study period ; 5 years post implant ]
    The pre-procedure and 1 year post-procedure NYHA distribution (numbers and percentage of subjects) will be tabulated

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient has mitral valve disease requiring surgical replacement
  2. Patient has provided written informed consent prior to mitral valve surgery
  3. Patient is expected to survive surgery and be discharged
  4. Patient is willing to comply with specified follow-up evaluations
  5. Patient is 13 years of age or older

Exclusion Criteria:

  1. Patient has life expectancy < 12 months due to non-cardiac co-morbid conditions;
  2. Patient has/had active endocarditis within the last 3 months
  3. Patient requires replacement of a native or previously implanted prosthetic, tricuspid, pulmonic or aortic valve;
  4. Patient was previously enrolled and implanted in the study
  5. Patient has/had prior aortic, tricuspid and/ or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ
  6. Patient has a body surface area (BSA) > 1.9m2
  7. Female patients who are pregnant, planning to become pregnant, or lactating
  8. Patient has a documented history of substance ( drug or alcohol) abuse
  9. Patient is currently a prison inmate
  10. Patient is currently participating in an investigational drug or another device study
  11. Patient is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism
  12. Patient has active myocarditis
  13. Patient has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event and has not returned to baseline or stabilized > 30 days prior to the planned v alve implant surgery
  14. Patient has an abnormality such as an aortic aneurysm (e.g. due to cystic medial necrosis or Marfan's syndrome), aortic dissection, or ventricular aneurysm that might place

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01312779

United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
United States, Illinois
Northwestern Hospital
Chicago, Illinois, United States, 60611
United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, Tennessee
Saint Thomas Health
Nashville, Tennessee, United States, 37205
The John Paul II Hospital in Krakow
Krakow, Poland, 31-202
Sponsors and Collaborators
Edwards Lifesciences
Study Chair: Jan Champion Edwards Lifesciences

Responsible Party: Edwards Lifesciences Identifier: NCT01312779     History of Changes
Other Study ID Numbers: 2008-07
First Posted: March 11, 2011    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by Edwards Lifesciences:
Mitral Valve Replacement
23mm CEP

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases