Clinical trial NCT01312779: Magna Mitral - 23mm
Official title: Clinical Evaluation of the Size 23mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Heart Valve Disease
Keywords: Mitral Valve Replacement
23mm CEP
Magna
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2011-03-11
Enrollment: 39
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Early Adverse Events Divided
timeFrame: Events occuring within 30 days of procedure
measure: Percent of Late Adverse Events
timeFrame: Events occurring >= 31 days and up through 5 years post-implant
measure: Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
timeFrame: >30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
measure: Subject's Average Effective Orifice Area (EOA) Measurement
timeFrame: Pre-procedure and 1 Year post-Implant
Secondary outcomes:
Other outcomes:
measure: Subject's Average Mean Gradient Measurement
timeFrame: Pre-procedure and 1 Year post-implant
measure: Subject's Average Peak Gradient Measurement
timeFrame: Pre-procedure and 1 Year post-implant
measure: Subject's Average Effective Orifice Area Index (EOAI) Measurement
timeFrame: Pre-procedure and 1 Year post-implant
measure: Subject's Average Performance Index Measurement
timeFrame: Pre-procedure and 1 Year post-Implant
measure: Subject's Average Cardiac Output
timeFrame: Pre-procedure and 1 Year post-implant
measure: Subject's Average Cardiac Index
timeFrame: Pre-procedure and 1 Year post-implant
measure: Subject's Average Left Ventricular Mass Regression
timeFrame: Pre-procedure and 1 Year post-implant
measure: Subject's Severity of Central Mitral Regurgitation at 1 Year Post-implant.
timeFrame: 1 Year post-implant
measure: Subject's Average Red Blood Cells Count
timeFrame: Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
measure: Subject's Average White Blood Cell Count
timeFrame: Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
measure: Subject's Average Hematocrit Percentage
timeFrame: Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
measure: Subject's Average Plasma Free Hemoglobin
timeFrame: Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
measure: Subject's Average Hemoglobin Count
timeFrame: Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
measure: Subject's Average Platelet Count
timeFrame: Baseline, 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
measure: Number and Percentage of Subjects in NYHA Functional Class I or II at 1 Year Post-Implant.
timeFrame: Baseline and 1 Year post-implant
measure: Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline
timeFrame: 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
measure: Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
timeFrame: 6 Months and 1 Year post-implant
Locations:
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Krakow
country: Poland
facility: The John Paul II Hospital in Krakow
Study officials:
References: