Magna Mitral - 23mm

Not Applicable

Completed

• Conditions: Mitral Heart Valve Disease
• Interventions: Device: Implantation of CEP Magna Mitral Model 7000TFX

• Registration Number: NCT01312779
• Lead Sponsor: Edwards Lifesciences

Brief 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.

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-09
• Study First Submitted QC: 2011-03-09
• Study First Posted: 2011-03-11
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Results First Submitted: 2020-02-18
• Results First Submitted QC: 2020-02-18
• Status Verified: 2020-03
• Results First Posted: 2020-03-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects receive implant	Implantation of CEP Magna Mitral Model 7000TFX	Subjects serve as own control

Primary Outcome Measures

Name	Time	Method
Percent of Late Adverse Events	Events occurring >= 31 days and up through 5 years post-implant	Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Percent of Early Adverse Events Divided	Events occuring within 30 days of procedure	Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days	>30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant	Subject's freedom from Serious Adverse Events at \> 30 days post-implant. Time to events were estimated by Kaplan-Meier method.
Subject's Average Effective Orifice Area (EOA) Measurement	Pre-procedure and 1 Year post-Implant	Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time.

Trial Locations

Locations (6)

Northwestern Hospital; 🇺🇸 Chicago, Illinois, United States

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States

The John Paul II Hospital in Krakow; 🇵🇱 Krakow, Poland

Florida Hospital; 🇺🇸 Orlando, Florida, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

University of Iowa Hospitals & Clinics; 🇺🇸 Iowa City, Iowa, United States