N/A N=39 Treatment

Magna Mitral - 23mm

Mitral Heart Valve Disease

Bottom Line

View on ClinicalTrials.gov: NCT01312779 ↗

Enrolled (actual)

Serious AEs

100.0%

Results posted

Mar 2020

Primary outcome: Primary: Percent of Early Adverse Events Divided — 8.3; 0.0; 0.0; 0.0 percentage of subjects

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Implantation of CEP Magna Mitral Model 7000TFX (Device)
Age: Pediatric, Adult, Older Adult · 13+ yrs
Sex: All
Sponsor: Edwards Lifesciences
Primary completion: Nov 2018

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	—

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.

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

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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.