Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01171625
• Collaborator: (none)
• Enrollment: 283
• Locations: 13
• Arm: 1
• Actual Duration (Months): 131
• Patients Per Site: 21.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Aortic Valve Disorder; Heart Failure; Aortic Valve Stenosis; Aortic Valve Insufficiency	Device: Implantation of CEP Magna Ease Model 3300TFX	N/A

Detailed Description

This is a prospective, single-arm, multi-center, interventional study to be conducted in the US and outside the US (OUS). This study will enroll a minimum of 225 patients implanted with the study valve in order to achieve 101 aortic valve replacement subjects each followed for a minimum of 8 years. The study will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged or malfunctioning natural or prosthetic aortic valve. Patients will be followed and assessed after implant at discharge, 6 months, one year, and annually for a minimum of 8 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 283 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX
• Actual Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Sep 1, 2018
• Actual Study Completion Date: Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: CEP Aortic Bioprothesis, model 3300TFX	Device: Implantation of CEP Magna Ease Model 3300TFX; Heart Valve Surgery; Other Names: CEP Magna Ease MOdel 3300TFX

Outcome Measures

Primary Outcome Measures

1. Subject's Percentage of Long Term Safety Performance [31 days through 8 years post-implant]

   Long term safety performance will be evaluated by comparing the linearized yearly rates to the objective performance criteria (OPC) referenced in the Food and Drug Administration (FDA) 1994 Draft Heart Valve Guidance. Expressed as the 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).

2. Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant [8 years post-implant]

   The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

3. Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline [8 Years post-implant]

   The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

Secondary Outcome Measures

1. Percent of Early Adverse Events [Events occurring 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.

2. Percentage of Late Adverse Events [Events occurring >= 31 days and up through 8 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).

3. Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days [1 Year, 2 Years, 3 Years, 4 Years, 5 Years, 6 Years, 7 Years, and 8 Years post-implant]

   Subject's freedom from Serious Adverse Events at > 30 days post-implant. Time to events were estimated by Kaplan-Meier method.

4. Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant [8 years post-implant]

   Peak systolic gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. The data summary will be stratified by valve size.

5. Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant. [8 years post-implant]

   Mean systolic gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Mean gradient values depend on the size and type of valve. The data summary will be stratified by valve size.

6. Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant. [8 years post-implant]

   Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. The data summary will be stratified by valve size.

7. Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant. [8 years post-implant]

   Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. The data summary will be stratified by valve size.

8. Subject's Average Performance Index Measurements at 8 Years Post-implant. [8 years post-implant]

   Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. The data summary will be stratified by valve size.

9. Subject's Average Cardiac Output Measurements at 8 Years Post-implant. [8 years post-implant]

   The amount of blood the heart pumps through the circulatory system in a minute. The data summary will be stratified by valve size.

10. Subject's Average Cardiac Index Measurements at 8 Years Post-implant. [8 years post-implant]

    Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual. The data summary will be stratified by valve size.

11. Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant. [8 years post-implant]

    Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.

12. Subject's Average White Blood Cell Count Measurement Over Time. [6 months and annually for 8 years post-implant]

    Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.

13. Subject's Average Red Blood Cells Count Over Time. [6 months and annually for 8 years post-implant]

    Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.

14. Subject's Average Hematocrit Percentage Over Time. [6 months and annually for 8 years post-implant]

    Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood.

15. Subject's Average Hemoglobin Count Over Time. [6 months and annually for 8 years post-implant]

    Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.

16. Subject's Average Platelet Count Over Time. [6 months and annually for 8 years post-implant]

    Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.

17. Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time. [6 months and annually for 8 years post-implant]

    Laboratory Analysis of Serum Lactate Dehydrogenase on blood drawn from subjects; The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues.

18. Subject's Average Haptoglobin Measurement Over Time. [6 months and annually for 8 years post-implant]

    Laboratory Analysis of haptoglobin on blood drawn from subjects; haptoglobin is a protein produced by the liver.

19. Subject's Average Reticulocytes Percentage Over Time. [6 months and annually for 8 years post-implant]

    Laboratory Analysis of reticulocytes on blood drawn from subjects. Reticulocytes are newly produced immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood.

20. Subject's Average Score on the EQ-5D- Quality of Life Questionnaire at Baseline and 6 Months Post-Implant. [Baseline and 6 Months Post-Implant]

    The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from a minimum of 0 and a maximum of 100 where zero is the 'worst state imaginable' and 100 is the 'best state imaginable'.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. The patient requires, as indicated in the preoperative evaluation, a replacement aortic valve.

2. The patient is an average or better operative risk.

3. The patient is geographically stable and agrees to attend follow-up assessments at the hospital of surgical services for at least 8 years.

4. The patient is 18 years or older.

5. The patient has signed and dated the subject informed consent form prior to surgery.

Exclusion Criteria:

1. The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.

2. The patient presents with active endocarditis within the last 3 months.

3. The patient has an abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidism).

4. The patient has an aneurismal aortic degenerative condition (e.g., cystic medial necrosis, Marfan's syndrome).

5. The patient is pregnant or lactating.

6. The patient is an intravenous drug abuser.

7. The patient is currently a prison inmate.

8. The patient is currently participating in a study of an investigational drug or device.

9. The patient requires replacement of a native or prosthetic mitral, tricuspid or pulmonic valve.

10. The patient requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device.

11. The patient was previously enrolled in the study.

12. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mercy General Hospital	Sacramento	California	United States	95819
2	Cooper University Hospital	Camden	New Jersey	United States	08103
3	Morristown Memorial Hospital	Morristown	New Jersey	United States	09762
4	Providence Heart & Vascular Institute	Portland	Oregon	United States	97225
5	St. Marks Hospital	Salt Lake City	Utah	United States	84124
6	Universitatslinik fur Chirurgie	Innsbruck		Austria	6020
7	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
8	St. Paul's Hospital	Vancouver		Canada	V6Z 1Y6
9	Liknik fur Herz und BefaBchirurgie Im Deuschen Herzzentrum	Munich	Lazarettstr	Germany	36
10	Klinik fur Herz-, Thorax-, Transplantations- und Gefabchirurgie	Hannover		Germany	D-30625
11	Hospital Peutra de Hierro	San Martin de Porres 4	Madrid	Spain	CP-28035
12	Papworth Hospital NHS foundation Trust	Papworth Everard	Cambridge	United Kingdom	CV23 3RE
13	Blackpool Victoria Hospital	Blackpool	Lancashire	United Kingdom	FY8 8NR

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 15, 2009

More Information

Additional Information:

• Measure of Health Status Survey (EQ-5D)
• New York Heart Association Classification

Publications

None provided.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT01171625
• Other Study ID Numbers: 2007-08
• First Posted: Jul 28, 2010
• Last Update Posted: Apr 17, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Edwards Lifesciences: PERIMOUNT, Aortic valve replacement/regurgitation
• Additional relevant MeSH terms: Coronary Artery Disease; Aortic Valve Stenosis; Aortic Valve Insufficiency; Aortic Valve Disease

Study Results

Participant Flow

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Period Title: Overall Study
STARTED	283
Subjects Implanted With Device	258
COMPLETED	103
NOT COMPLETED	180

Baseline Characteristics

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Overall Participants	258
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.5 (8.8)
Sex: Female, Male (Count of Participants)
Female	91 35.3%
Male	167 64.7%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Subject's Percentage of Long Term Safety Performance
Description	Long term safety performance will be evaluated by comparing the linearized yearly rates to the objective performance criteria (OPC) referenced in the Food and Drug Administration (FDA) 1994 Draft Heart Valve Guidance. Expressed as the 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).
Time Frame	31 days through 8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	258
Thromboembolism	1.5
All Hemorrhage	2.7
All Perivalvular Leak	0.2
Endocarditis	0.4

2. Primary Outcome

Title	Number of Subject's in NYHA Functional Class I or II at 8 Year Post-Implant
Description	The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
Time Frame	8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	98
Class I	57 22.1%
Class II	35 13.6%

3. Primary Outcome

Title	Subject's New York Heart Association (NYHA) Functional Class at 8 Years Post-Implant Compared to Baseline
Description	The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Time Frame	8 Years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	97
Improve	60 23.3%
Same	31 12%
Worse	6 2.3%

4. Secondary Outcome

Title	Percent of Early Adverse Events
Description	Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.
Time Frame	Events occurring within 30 days of procedure

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	258
Bleeding Event	6.2
Major Bleeding Event	5.0
Thromboembolism	1.9
Endocarditis	0.0
Structural Valve Deterioration	0.0
Reoperation Due to SVD	0.0
Hemolysis	0.0
Non-Structural Valve Deterioration	0.4
Perivalvular Leak	0.4
Major Perivalvular Leak	0.4
Valve Thrombosis	0.0
Explant	1.2
Death	0.4
Valve-related death	0.0

5. Secondary Outcome

Title	Percentage of Late Adverse Events
Description	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).
Time Frame	Events occurring >= 31 days and up through 8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	258
Bleeding Event	2.7
Major Bleeding Event	1.3
Thromboembolism	1.5
Endocarditis	0.4
Structural Valve Deterioration	1.0
Reoperation Due to SVD	0.6
Hemolysis	0.1
Non-Structural Valve Deterioration	0.3
Perivalvular Leak	0.2
Major Perivalvular Leak	0.1
Valve Thrombosis	0.0
Explant	0.5
Death	2.3
Valve-related death	0.5

6. Secondary Outcome

Title	Percent of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
Description	Subject's freedom from Serious Adverse Events at > 30 days post-implant. Time to events were estimated by Kaplan-Meier method.
Time Frame	1 Year, 2 Years, 3 Years, 4 Years, 5 Years, 6 Years, 7 Years, and 8 Years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Magna Ease™, Model 3300TFX - 1 Year Post-Implant	Magna Ease™, Model 3300TFX - 2 Year Post-Implant	Magna Ease™, Model 3300TFX - 3 Year Post-Implant	Magna Ease™, Model 3300TFX - 4 Year Post-Implant	Magna Ease™, Model 3300TFX - 5 Year Post-Implant	Magna Ease™, Model 3300TFX - 6 Year Post-Implant	Magna Ease™, Model 3300TFX - 7 Year Post-Implant	Magna Ease™, Model 3300TFX - 8 Year Post-Implant
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	258	258	258	258	258	258	258	258
Death	97.60	97.19	95.50	93.76	91.54	89.20	85.16	80.69
Valve-related death	99.60	99.60	98.74	98.28	97.81	97.31	96.66	95.79
Reoperation	97.63	97.21	96.78	95.89	95.89	95.37	94.07	89.83
Explant	98.04	97.62	97.19	96.30	96.30	96.30	95.65	94.81
Bleeding Event	88.44	86.76	84.13	83.22	81.79	81.29	80.63	77.95
Major Bleeding Event	92.51	92.09	90.33	90.33	88.91	88.40	87.75	85.08
Thromboembolism	96.03	94.32	92.56	92.11	90.70	89.68	88.39	86.68
Endocarditis	98.81	98.39	98.39	97.94	97.94	97.94	97.27	97.27
Perivalvular leak	98.78	98.36	98.36	98.36	98.36	98.36	98.36	98.36
Major perivalvular leak	99.20	99.20	99.20	99.20	99.20	99.20	99.20	99.20
Hemolysis	99.18	99.18	99.18	99.18	99.18	99.18	99.18	99.18
Non-structural valve dysfunction	98.78	98.36	98.36	97.91	97.91	97.91	97.91	97.91
Structural valve deterioration	100.0	99.57	99.13	99.13	99.13	97.07	95.74	90.08
Valve thrombosis	100.0	100.0	100.0	100.0	100.0	100.0	100.0	100.0

7. Secondary Outcome

Title	Subject's Average Peak Systolic Gradient (mmHg) Measurements at 8 Years Post-implant
Description	Peak systolic gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. The data summary will be stratified by valve size.
Time Frame	8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	89
19 mm	24.6 (17.94)
21 mm	24.7 (23.52)
23 mm	26.3 (21.41)
25 mm	21.6 (8.94)
27 mm	22.1 (8.81)
29 mm	23.1 (15.41)

8. Secondary Outcome

Title	Subject's Average Mean Systolic Gradient (mmHg) Measurements at 8 Years Post-implant.
Description	Mean systolic gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Mean gradient values depend on the size and type of valve. The data summary will be stratified by valve size.
Time Frame	8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	89
19 mm	17.7 (6.38)
21 mm	17.2 (10.82)
23 mm	16.2 (10.46)
25 mm	12.7 (4.56)
27 mm	12.2 (4.51)
29 mm	13.3 (9.48)

9. Secondary Outcome

Title	Subject's Average Effective Orifice Area Measurements at 8 Years Post-implant.
Description	Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. The data summary will be stratified by valve size.
Time Frame	8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	86
19 mm	1.0 (0.15)
21 mm	1.4 (0.40)
23 mm	1.4 (0.53)
25 mm	1.7 (0.47)
27 mm	2.1 (0.32)
29 mm	1.9 (0.44)

10. Secondary Outcome

Title	Subject's Average Effective Orifice Area Index (EOAI) Measurements at 8 Years Post-implant.
Description	Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. The data summary will be stratified by valve size.
Time Frame	8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	86
19 mm	0.6 (0.11)
21 mm	0.7 (0.20)
23 mm	0.8 (0.32)
25 mm	0.8 (0.21)
27 mm	1.1 (0.10)
29 mm	0.9 (0.24)

11. Secondary Outcome

Title	Subject's Average Performance Index Measurements at 8 Years Post-implant.
Description	Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. The data summary will be stratified by valve size.
Time Frame	8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	86
19 mm	0.5 (0.09)
21 mm	0.5 (0.14)
23 mm	0.4 (0.18)
25 mm	0.4 (0.10)
27 mm	0.4 (0.04)
29 mm	0.3 (0.09)

12. Secondary Outcome

Title	Subject's Average Cardiac Output Measurements at 8 Years Post-implant.
Description	The amount of blood the heart pumps through the circulatory system in a minute. The data summary will be stratified by valve size.
Time Frame	8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	86
19 mm	3.6 (0.32)
21 mm	5.2 (1.23)
23 mm	5.0 (1.10)
25 mm	5.1 (1.28)
27 mm	6.3 (2.10)
29 mm	5.3 (0.78)

13. Secondary Outcome

Title	Subject's Average Cardiac Index Measurements at 8 Years Post-implant.
Description	Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual. The data summary will be stratified by valve size.
Time Frame	8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	86
19 mm	2.3 (0.22)
21 mm	2.9 (0.55)
23 mm	2.7 (0.60)
25 mm	2.6 (0.60)
27 mm	3.1 (0.91)
29 mm	2.6 (0.32)

14. Secondary Outcome

Title	Subject's Amount of Aortic Valvular Regurgitation at 8 Years Post-Implant.
Description	Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.
Time Frame	8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	88
0 None	58 22.5%
+1 Trivial	20 7.8%
+2 Mild	9 3.5%
+3 Moderate	1 0.4%
+4 Severe	0 0%

15. Secondary Outcome

Title	Subject's Average White Blood Cell Count Measurement Over Time.
Description	Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
Time Frame	6 months and annually for 8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	258
6 Months	7.0 (2.0)
1 Year	6.8 (1.7)
2 Years	6.9 (1.7)
3 Years	6.9 (2.1)
4 Years	6.9 (2.1)
5 Years	6.9 (1.7)
6 Years	7.1 (2.3)
7 Years	7.2 (1.6)
8 Years	7.4 (2.3)

16. Secondary Outcome

Title	Subject's Average Red Blood Cells Count Over Time.
Description	Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.
Time Frame	6 months and annually for 8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	258
6 Months	4.7 (0.6)
1 Year	4.7 (0.6)
2 Years	4.7 (0.5)
3 Years	4.6 (0.5)
4 Years	4.6 (0.5)
5 Years	4.6 (0.6)
6 Years	4.6 (0.5)
7 Years	4.7 (0.6)
8 Years	4.7 (0.5)

17. Secondary Outcome

Title	Subject's Average Hematocrit Percentage Over Time.
Description	Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood.
Time Frame	6 months and annually for 8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	258
6 Months	40.6 (4.0)
1 Year	41.2 (4.0)
2 Years	41.7 (4.0)
3 Years	41.4 (3.9)
4 Years	41.8 (4.1)
5 Years	41.6 (7.9)
6 Years	41.2 (5.3)
7 Years	41.4 (4.6)
8 Years	42.6 (6.6)

18. Secondary Outcome

Title	Subject's Average Hemoglobin Count Over Time.
Description	Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
Time Frame	6 months and annually for 8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	258
6 Months	13.7 (1.6)
1 Year	14.0 (1.6)
2 Years	14.1 (1.6)
3 Years	14.0 (1.5)
4 Years	14.1 (1.5)
5 Years	14.0 (1.6)
6 Years	14.0 (1.7)
7 Years	14.0 (1.8)
8 Years	14.3 (1.4)

19. Secondary Outcome

Title	Subject's Average Platelet Count Over Time.
Description	Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
Time Frame	6 months and annually for 8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	258
6 Months	207.9 (64.4)
1 Year	202.5 (50.1)
2 Years	204.7 (56.3)
3 Years	195.6 (50.9)
4 Years	198.6 (57.1)
5 Years	198.3 (74.7)
6 Years	196.9 (54.7)
7 Years	199.1 (58.3)
8 Years	190.7 (51.1)

20. Secondary Outcome

Title	Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time.
Description	Laboratory Analysis of Serum Lactate Dehydrogenase on blood drawn from subjects; The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues.
Time Frame	6 months and annually for 8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	258
6 Months	240.8 (112.6)
1 Year	235.5 (103.3)
2 Years	234.6 (106.5)
3 Years	236.1 (102.3)
4 Years	243.9 (107.1)
5 Years	236.7 (94.3)
6 Years	255.3 (162.2)
7 Years	238.2 (88.5)
8 Years	263.0 (117.9)

21. Secondary Outcome

Title	Subject's Average Haptoglobin Measurement Over Time.
Description	Laboratory Analysis of haptoglobin on blood drawn from subjects; haptoglobin is a protein produced by the liver.
Time Frame	6 months and annually for 8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	258
6 Months	118.4 (66.9)
1 Year	114.7 (70.7)
2 Years	115.6 (61.4)
3 Years	116.3 (58.9)
4 Years	112.8 (62.3)
5 Years	127.1 (104.0)
6 Years	115.6 (58.9)
7 Years	125.0 (87.4)
8 Years	109.8 (53.7)

22. Secondary Outcome

Title	Subject's Average Reticulocytes Percentage Over Time.
Description	Laboratory Analysis of reticulocytes on blood drawn from subjects. Reticulocytes are newly produced immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood.
Time Frame	6 months and annually for 8 years post-implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	258
6 Months	1.2 (1.5)
1 Year	1.2 (0.5)
2 Years	1.2 (0.5)
3 Years	1.2 (0.5)
4 Years	1.4 (1.3)
5 Years	1.8 (6.2)
6 Years	4.4 (13.4)
7 Years	5.4 (16.5)
8 Years	4.5 (14.8)

23. Secondary Outcome

Title	Subject's Average Score on the EQ-5D- Quality of Life Questionnaire at Baseline and 6 Months Post-Implant.
Description	The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from a minimum of 0 and a maximum of 100 where zero is the 'worst state imaginable' and 100 is the 'best state imaginable'.
Time Frame	Baseline and 6 Months Post-Implant

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease, Model 3300TFX, device where data is available.

Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
Measure Participants	96
Baseline	75.8 (15.1)
6 Months Follow-up	84.3 (13.6)

Adverse Events

Time Frame	Events occurring from baseline through eight years post implant.
Adverse Event Reporting Description	The outcome is reported for subjects who received the Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX device where data is available.
Arm/Group Title	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
Arm/Group Description	Subjects who received the Carpentier-Edwards® PERIMOUNT® Magna Ease™ valve, Model 3300TFX, undergoing isolated aortic valve replacement.
All Cause Mortality
	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
	Affected / at Risk (%)	# Events
Total	38/258 (14.7%)
Serious Adverse Events
	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
	Affected / at Risk (%)	# Events
Total	211/258 (81.8%)
Blood and lymphatic system disorders
Anemia	20/258 (7.8%)	23
Bleeding - Major	32/258 (12.4%)	34
Bleeding - Minor	12/258 (4.7%)	12
Coagulopathy	1/258 (0.4%)	1
Hematological Disorder	6/258 (2.3%)	8
Septicemia	5/258 (1.9%)	7
Cardiac disorders
Angina	11/258 (4.3%)	16
Arrhythmia	87/258 (33.7%)	101
Cardiac Arrest	2/258 (0.8%)	2
Cardiac Conduction Disturbance	6/258 (2.3%)	6
Cardiac Failure	14/258 (5.4%)	17
Cardiovascular - Other	11/258 (4.3%)	11
Cardiovascular Dissection / Tear / Injury	1/258 (0.4%)	1
Endocarditis	6/258 (2.3%)	6
Hypotension	2/258 (0.8%)	2
Mitral Regurgitation (Native)	1/258 (0.4%)	1
Myocardial Infarct	7/258 (2.7%)	7
NSVD - Other non-structural valve dysfunction	1/258 (0.4%)	1
NSVD - Paravalvular Leak - Major	2/258 (0.8%)	2
NSVD - Paravalvular Leak - Minor	1/258 (0.4%)	1
Pericardial Effusion	20/258 (7.8%)	21
Pleural Effusion	37/258 (14.3%)	37
Pneumothorax / Hemothorax	1/258 (0.4%)	1
Pulmonary Embolism	3/258 (1.2%)	3
SVD - Other structural valve deterioration	8/258 (3.1%)	8
SVD - Study valve calcification	2/258 (0.8%)	2
Syncope	2/258 (0.8%)	3
Thromboembolism - Non-cerebral	1/258 (0.4%)	1
Thromboembolism - Stroke	13/258 (5%)	13
Thromboembolism - TIA	6/258 (2.3%)	6
Vascular Complication	9/258 (3.5%)	13
Eye disorders
Vision Disorder	8/258 (3.1%)	10
Gastrointestinal disorders
Gastro-Intestinal Complication	26/258 (10.1%)	32
Hepatic Complication	3/258 (1.2%)	3
General disorders
Cancer	27/258 (10.5%)	39
Drug Reaction	3/258 (1.2%)	3
Fever - Unknown Origin	2/258 (0.8%)	3
Multiple Organ Failure	5/258 (1.9%)	5
Other	63/258 (24.4%)	99
Sudden Death	2/258 (0.8%)	2
Infections and infestations
Infection / Inflammation	40/258 (15.5%)	54
Metabolism and nutrition disorders
Metabolic Complication	3/258 (1.2%)	3
Musculoskeletal and connective tissue disorders
Bone Fracture	9/258 (3.5%)	9
Edema	1/258 (0.4%)	1
Sternal / Thoracic Wound Complication	9/258 (3.5%)	12
Psychiatric disorders
Neurological Complication	8/258 (3.1%)	8
Psychiatric Complication	6/258 (2.3%)	6
Renal and urinary disorders
Renal Complication	6/258 (2.3%)	6
Urinary Tract Infection	3/258 (1.2%)	3
Respiratory, thoracic and mediastinal disorders
Respiratory Complication	27/258 (10.5%)	30
Other (Not Including Serious) Adverse Events
	Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX
	Affected / at Risk (%)	# Events
Total	184/258 (71.3%)
Blood and lymphatic system disorders
Anemia	3/258 (1.2%)	3
Bleeding - Minor	12/258 (4.7%)	13
Hematological Disorder	3/258 (1.2%)	4
Septicemia	1/258 (0.4%)	1
Cardiac disorders
Angina	4/258 (1.6%)	6
Arrhythmia	58/258 (22.5%)	80
Cardiac Conduction Disturbance	15/258 (5.8%)	15
Cardiac Failure	2/258 (0.8%)	2
Cardiovascular - Other	7/258 (2.7%)	8
Hemolysis	2/258 (0.8%)	2
Hypertension	1/258 (0.4%)	1
Hypotension	1/258 (0.4%)	1
Myocardial Infarct	2/258 (0.8%)	2
NSVD - Paravalvular Leak - Minor	1/258 (0.4%)	1
Pericardial Effusion	17/258 (6.6%)	17
Pleural Effusion	36/258 (14%)	37
Pneumothorax / Hemothorax	3/258 (1.2%)	3
Pulmonary Embolism	1/258 (0.4%)	1
SVD - Other structural valve deterioration	5/258 (1.9%)	5
Syncope	7/258 (2.7%)	7
Thromboembolism - Non-cerebral	1/258 (0.4%)	1
Thromboembolism - TIA	5/258 (1.9%)	5
Tricuspid Regurgitation (Native)	1/258 (0.4%)	1
Vascular Complication	4/258 (1.6%)	4
Eye disorders
Abnormal Lab Values	7/258 (2.7%)	7
Vision Disorder	11/258 (4.3%)	13
Gastrointestinal disorders
Gastro-Intestinal Complication	10/258 (3.9%)	10
General disorders
Cancer	4/258 (1.6%)	4
Drug Reaction	1/258 (0.4%)	1
Fever - Unknown Origin	5/258 (1.9%)	5
Other	84/258 (32.6%)	165
Hepatobiliary disorders
Hepatic Complication	2/258 (0.8%)	2
Infections and infestations
Infection / Inflammation	42/258 (16.3%)	48
Metabolism and nutrition disorders
Metabolic Complication	1/258 (0.4%)	1
Musculoskeletal and connective tissue disorders
Bone Fracture	7/258 (2.7%)	7
Edema	2/258 (0.8%)	2
Sternal / Thoracic Wound Complication	3/258 (1.2%)	3
Nervous system disorders
Neurological Complication	1/258 (0.4%)	1
Psychiatric disorders
Psychiatric Complication	2/258 (0.8%)	2
Renal and urinary disorders
Renal Complication	6/258 (2.3%)	7
Urinary Tract Infection	2/258 (0.8%)	3
Respiratory, thoracic and mediastinal disorders
Atelectasis	1/258 (0.4%)	1
Respiratory Complication	15/258 (5.8%)	17

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Publication of overall study results which have not been released requires written approval of Sponsor, but presentation of site-specific results can occur subject to review by Sponsor. Manuscripts will be submitted to Sponsor for review 60 days prior to submission of manuscript for publication/presentation. Sponsor may ask for a 90 day delay of submission of manuscripts for publication to protect proprietary information and filing of related patent applications.