Magna Mitral - 23mm

Edwards Lifesciences

Status: Completed

Conditions: Mitral Heart Valve Disease

Treatments: Device: Implantation of CEP Magna Mitral Model 7000TFX

Study type: Interventional

Funder types: Industry

Identifiers

NCT01312779

2008-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

39 participants in 1 patient group

All subjects receive implant

Other group

Description:

Subjects serve as own control

Treatment:

Device: Implantation of CEP Magna Mitral Model 7000TFX