Magna Mitral - 23mm
This study is currently recruiting participants.
Verified February 2013 by Edwards Lifesciences
Sponsor:
Edwards Lifesciences
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
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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:
- Patient has mitral valve disease requiring surgical replacement
- Patient has provided written informed consent prior to mitral valve surgery
- Patient is expected to survive surgery and be discharged
- Patient is willing to comply with specified follow-up evaluations
- Patient is 13 years of age or older
Exclusion Criteria:
- Patient has life expectancy < 12 months due to non-cardiac co-morbid conditions;
- Patient has/had active endocarditis within the last 3 months
- Patient requires replacement of a native or previously implanted prosthetic, tricuspid, pulmonic or aortic valve;
- Patient was previously enrolled and implanted in the study
- 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
- Patient has a body surface area (BSA) > 1.9m2
- Female patients who are pregnant, planning to become pregnant, or lactating
- Patient has a documented history of substance ( drug or alcohol) abuse
- Patient is currently a prison inmate
- Patient is currently participating in an investigational drug or another device study
- Patient is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism
- Patient has active myocarditis
- 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
- 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