N/A
Completed N=39
Magna Mitral - 23mm
Mitral Heart Valve Disease
Source: ClinicalTrials.gov NCT01312779 ↗
Enrolled (actual)
39
Serious AEs
100.0%
Results posted
Mar 2020
Primary outcomePrimary: Percent of Early Adverse Events Divided — 8.3; 0.0; 0.0; 0.0 percentage of subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Early Adverse Events Divided |
8.3; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percent of Late Adverse Events |
4.5; 2.2; 2.2; 0.0; 2.2; 2.2 | — |
| PRIMARY Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days |
100.00; 90.91; 90.91; 90.91; 80.81; 80.81 | — |
| PRIMARY Subject's Average Effective Orifice Area (EOA) Measurement |
0.8; 1.2 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01312779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.