Overview

This trial is active, not recruiting.

Condition mitral heart valve disease
Treatment implantation of cep magna mitral model 7000tfx
Sponsor Edwards Lifesciences
Start date March 2011
End date December 2017
Trial size 20 participants
Trial identifier NCT01312779, 2008-07

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Subjects serve as own control
implantation of cep magna mitral model 7000tfx
Heart valve surgery: CEP Magna Mitral Model 7000 TFX

Primary Outcomes

Measure
Mean effective orifice area at 1 year post implant
time frame: Entire study period-5 years post implant

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 13 years old.

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

Additional Information

Official title Clinical Evaluation of the Size 23mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.