Magna Mitral - 23mm

This study is currently recruiting participants.
Verified February 2013 by Edwards Lifesciences
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01312779
First received: March 9, 2011
Last updated: February 6, 2013
Last verified: February 2013
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312779

Contacts
Contact: Carol Renner, BSN 949-250-2389 carol_renner@edwards.com
Contact: Sandi Parsons 949-250-2875 Sandra_Parsons@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: Jade Irving, BA     312-695-6826     jirving@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: Michael J. Bates, 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: February 6, 2013
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 June 18, 2013