Magna Mitral - 23mm

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Edwards Lifesciences
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01312779
First received: March 9, 2011
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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 Intervention
Mitral Heart Valve Disease
Device: Implantation of CEP Magna Mitral Model 7000TFX

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Size 23mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    The pre-procedure and 1 year post-procedure NYHA distribution (numbers and percentage of subjects) will be tabulated


Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312779

Contacts
Contact: Bruce Van Deman 949-250-2626 bruce_van_deman@edwards.com

Locations
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Beverly Mansker, RN, MBA    407-399-9231    Beverly.mansker@flhosp.org   
Contact: Melissa Leonard, RN, MBA, CCRP    407-303-7556    Melissa.leonard@flhosp.org   
Principal Investigator: Kevin Accola, MD         
United States, Illinois
Northwestern Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Kelly Johnston    312-926-7312    Kjohnst1@nmh.org   
Contact: Andrea Kim    312-695-6826    akim1@nmh.org   
Principal Investigator: S. Chris Malaisrie, MD         
Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Anne Sarwark, BA    312-227-4522    Asarwark@luriechildrens.org   
Principal Investigator: Hyde McKinney Russell, MD         
United States, Iowa
University of Iowa Hospitals & Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Ronda Wilson, RN,BSN, CCRC, RAII    319-353-6675    ronda-k-wilson@uiowa.edu   
Contact: Kimberly Miller, RN, BSN    319-353-6675    Kimberly-s-miller@uiowa.edu   
Principal Investigator: Sotiris J. Stamou, MD         
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Mary Pileggi, RN, BSN    856-757-9783    PILEGGI-MARY@CooperHealth.edu   
Principal Investigator: Michael Rosenbloom, MD         
Poland
The John Paul II Hospital in Krakow Recruiting
Krakow, Poland, 31-202
Contact: Maciej Bochenek, MD    +48 12 614 30 75    mbochenek@poczta.fm   
Principal Investigator: Prof. Jerzy Sadowski, MD, PhD         
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Principal Investigator: Kevin Accola, MD Florida Hospital Cardiovascular Research Institute
  More Information

No publications provided

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01312779     History of Changes
Other Study ID Numbers: 2008-07
Study First Received: March 9, 2011
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration
Poland: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 29, 2014