N/A
N=283
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX
Coronary Artery Disease · Aortic Valve Disorder · Heart Failure · Aortic Valve Stenosis · Aortic Valve Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT01171625 ↗Enrolled (actual)
283
Serious AEs
81.8%
Results posted
Apr 2020
Primary outcome: Primary: Subject's Percentage of Long Term Safety Performance — 1.5; 2.7; 0.2; 0.4 Percentage of events/late patient years
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Implantation of CEP Magna Ease Model 3300TFX (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject's Percentage of Long Term Safety Performance |
1.5; 2.7; 0.2; 0.4 | — |
| PRIMARY Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant |
57; 35 | — |
| PRIMARY Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline |
60; 31; 6 | — |
| SECONDARY Percent of Early Adverse Events |
6.2; 5.0; 1.9; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Late Adverse Events |
2.7; 1.3; 1.5; 0.4; 1.0; 0.6 | — |
| SECONDARY Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days |
97.60; 97.19; 95.50; 93.76; 91.54; 89.20 | — |
| SECONDARY Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant |
24.6; 24.7; 26.3; 21.6; 22.1; 23.1 | — |
| SECONDARY Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant. |
17.7; 17.2; 16.2; 12.7; 12.2; 13.3 | — |
| SECONDARY Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant. |
1.0; 1.4; 1.4; 1.7; 2.1; 1.9 | — |
| SECONDARY Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant. |
0.6; 0.7; 0.8; 0.8; 1.1; 0.9 | — |
| SECONDARY Subject's Average Performance Index Measurements at 8 Years Post-implant. |
0.5; 0.5; 0.4; 0.4; 0.4; 0.3 | — |
| SECONDARY Subject's Average Cardiac Output Measurements at 8 Years Post-implant. |
3.6; 5.2; 5.0; 5.1; 6.3; 5.3 | — |
| SECONDARY Subject's Average Cardiac Index Measurements at 8 Years Post-implant. |
2.3; 2.9; 2.7; 2.6; 3.1; 2.6 | — |
| SECONDARY Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant. |
58; 20; 9; 1; 0 | — |
| SECONDARY Subject's Average White Blood Cell Count Measurement Over Time. |
7.0; 6.8; 6.9; 6.9; 6.9; 6.9 | — |
| SECONDARY Subject's Average Red Blood Cells Count Over Time. |
4.7; 4.7; 4.7; 4.6; 4.6; 4.6 | — |
| SECONDARY Subject's Average Hematocrit Percentage Over Time. |
40.6; 41.2; 41.7; 41.4; 41.8; 41.6 | — |
| SECONDARY Subject's Average Hemoglobin Count Over Time. |
13.7; 14.0; 14.1; 14.0; 14.1; 14.0 | — |
| SECONDARY Subject's Average Platelet Count Over Time. |
207.9; 202.5; 204.7; 195.6; 198.6; 198.3 | — |
| SECONDARY Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time. |
240.8; 235.5; 234.6; 236.1; 243.9; 236.7 | — |
| SECONDARY Subject's Average Haptoglobin Measurement Over Time. |
118.4; 114.7; 115.6; 116.3; 112.8; 127.1 | — |
| SECONDARY Subject's Average Reticulocytes Percentage Over Time. |
1.2; 1.2; 1.2; 1.2; 1.4; 1.8 | — |
| SECONDARY Subject's Average Score on the EQ-5D- Quality of Life Questionnaire at Baseline and 6 Months Post-Implant. |
75.8; 84.3 | — |
Summary
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.
Eligibility Criteria
Inclusion Criteria
- The patient requires, as indicated in the preoperative evaluation, a replacement aortic valve.
- The patient is an average or better operative risk.
- The patient is geographically stable and agrees to attend follow-up assessments at the hospital of surgical services for at least 8 years.
- The patient is 18 years or older.
- The patient has signed and dated the subject informed consent form prior to surgery.
Exclusion Criteria
- The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
- The patient presents with active endocarditis within the last 3 months.
- The patient has an abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism).
- The patient has an aneurismal aortic degenerative condition (e.g., cystic medial necrosis, Marfan's syndrome).
- The patient is pregnant or lactating.
- The patient is an intravenous drug abuser.
- The patient is currently a prison inmate.
- The patient is currently participating in a study of an investigational drug or device.
- The patient requires replacement of a native or prosthetic mitral, tricuspid or pulmonic valve.
- The patient requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device.
- The patient was previously enrolled in the study.
- The patient had a prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ.
Data sourced from ClinicalTrials.gov (NCT01171625). 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.