Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX
Phase: NA
Conditions: Coronary Artery Disease, Aortic Valve Disorder, Heart Failure, Aortic Valve Stenosis, Aortic Valve Insufficiency
Sponsor: Edwards Lifesciences

Edwards Lifesciences LLC 
One Edwards Way  Irvine, CA USA  92614 
Phone: 949.250.2500  Fax: 949.250.2525  www.edwards.com 
Carpentier-Edwards PERIMOUNT Magna Ease 
Pericardial Bioprosthesis in the Aortic Position, 
Model 3300TFX  
NCT01171625 
September 15, 2009

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or disclosed 
without written permission from Edwards Lifesciences LLC 
POST APPROVAL STUDY # 2007-08  
CARPENTIER-EDWARDS® PERIMOUNT® MAGNA EASE™PERICARDIAL 
BIOPROSTHESIS in the AORTIC POSITION, MODEL 3300TFX 
Prepared by: 
____________________________________________ 
 
 ________________ 
 
  Date 
Approved by: 
______________________________________________      
 ________________ 
s 
Date 
______________________________________________      
 ________________ 
  
Date 
______________________________________________      
 ________________ 
 
Date 
Edwards Lifesciences LLC 
One Edwards Way 
Irvine, CA  92614 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or disclosed 
without written permission from Edwards Lifesciences LLC 
STUDY CONTACTS 
Sponsor: 
Edwards Lifesciences LLC 
One Edwards Way 
Irvine, CA USA 92614  
949 250 2500 
Study Contact:  
US and Canada 
Edwards Lifesciences LLC 
Heart Valve Therapy Clinical Affairs 
One Edwards Way 
Irvine, CA USA 92614 
Europe 
Clinical Programs Europe - HVT 
Edwards Lifesciences SA  
Chemin du Gapin 6 
1162 Saint-Prex, Switzerland  

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
i 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC 
 
 
 
CLINICAL PROTOCOL STUDY # 2007-08  
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE 
PERICARDIAL BIOPROSTHESIS in the AORTIC POSITION, 
MODEL 3300TFX 
 
 
Revision E 
 
September 15, 2009 
 
 
Protocol Change Status 
 
Protocol Revision # 
Revision Date 
Revision A 
(Never implemented) 
January 23, 2007 
Revision B 
(Implemented in Europe) 
September,  2007 
Draft Revision C 
(US and OUS) 
March 16, 2009 
Revision D 
(US and OUS) 
May 27, 2009 
Revision E 
(US and OUS) 
September 15, 2009 
 
 
 
Sponsor 
Edwards Lifesciences LLC 
One Edwards Way 
Irvine, CA  92614 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
ii 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC 
Table of Contents 
1.  CARPENTIER-EDWARDS® PERIMOUNT® MAGNA EASE™ PERICARDIAL 
BIOPROSTHESES STUDY SUMMARY .................................................................. 2 
2.  Carpentier-Edwards Perimount Magna Ease Pericardial Bioprosthesis in 
the Aortic Position Study Procedures Chart ........................................................ 4 
3.  INTRODUCTION ................................................................................................ 5 
4.  STUDY OVERVIEW ........................................................................................... 6 
4.1 
PURPOSE ........................................................................................................................... 6 
4.2 
ENDPOINTS ........................................................................................................................ 6 
4.2.1 
PRIMARY SAFETY ENDPOINTS ..................................................................................... 6 
4.2.2 
SECONDARY SAFETY ENDPOINTS ................................................................................ 6 
4.2.3 
PRIMARY EFFECTIVENESS ENDPOINTS ........................................................................ 7 
4.2.4 
SECONDARY EFFECTIVENESS ENDPOINTS ................................................................... 7 
5.  STUDY DESIGN ................................................................................................ 7 
5.1. 
STUDY SITE SELECTION .................................................................................................. 8 
5.2. 
STUDY TIMELINE ............................................................................................................... 9 
6.  PATIENT POPULATION ................................................................................. 10 
6.1 
ENTRY CRITERIA ............................................................................................................. 10 
6.2 
INCLUSION CRITERIA ..................................................................................................... 10 
6.3 
EXCLUSION CRITERIA .................................................................................................... 11 
7.  STUDY MATERIALS ....................................................................................... 12 
7.1. 
DEVICE DESCRIPTION .................................................................................................... 12 
8.  STUDY PROCEDURES ................................................................................... 13 
8.1 
PREOPERATIVE PROCEDURES .................................................................................... 14 
8.2 
OPERATIVE PROCEDURES ............................................................................................ 15 
8.3 
POSTOPERATIVE PROCEDURES .................................................................................. 17 
8.3.1 
DISCHARGE ................................................................................................................ 17 
8.3.2 
POSTOPERATIVE FOLLOW‐UP VISITS ......................................................................... 18 
8.3.3 
UNSCHEDULED VISIT ................................................................................................. 20 
9.  RISKS AND BENEFITS ................................................................................... 21 
10.  CLINICAL ADVERSE EVENTS ....................................................................... 22 
10.1 
OVERVIEW AND DEFINITIONS ....................................................................................... 22 
10.2 
ADVERSE EXPERIENCE REPORTING ........................................................................... 23 
10.3 
MEDICAL DEVICE REPORTING (MDR) .......................................................................... 24 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
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PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC 
10.4 
AUTOPSY/DEATH ............................................................................................................ 24 
10.5 
EXPLANTED VALVES ...................................................................................................... 24 
10.6 
PATIENT WITHDRAWAL .................................................................................................. 25 
10.7 
MISSED VISIT/ LOST TO FOLLOW-UP ........................................................................... 25 
11.  STATISTICAL ANALYSIS ............................................................................... 25 
11.1 
SAMPLE SIZE ................................................................................................................... 25 
11.2 
ANALYSIS POPULATION ................................................................................................. 28 
11.3 
SAFETY ANALYSIS .......................................................................................................... 28 
11.3.1 
PRIMARY SAFETY ENDPOINT ..................................................................................... 28 
11.3.2 
SECONDARY SAFETY ENDPOINTS .............................................................................. 28 
11.4 
EFFECTIVENESS ANALYSIS .......................................................................................... 29 
11.5 
POOLABILITY ................................................................................................................... 31 
11.6 
MISSING DATA ................................................................................................................. 31 
12.  ETHICAL AND REGULATORY CONSIDERATIONS ..................................... 31 
13.  HEALTH ECONOMIC INFORMATION ............................................................ 32 
14.  CASE REPORT FORMS ................................................................................. 32 
15.  STUDY TERMINATION ................................................................................... 34 
16.  RECORD RETENTION .................................................................................... 34 
17.  STUDY RESPONSIBILITIES ........................................................................... 34 
17.1 
INVESTIGATOR RESPONSIBILITIES ................................................................................. 34 
17.2 
SPONSOR/ STUDY MONITOR RESPONSIBILITIES ........................................................... 36 
17.3 
STUDY CHANGES ............................................................................................................ 36 
17.4 
IMPLANT DATA CARD .................................................................................................... 36 
17.5 
STUDY PUBLICATION ..................................................................................................... 37 
18.  REFERENCES ................................................................................................. 38 
 
 
 
  
 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
2 
 
 
1. CARPENTIER-EDWARDS® PERIMOUNT® MAGNA EASE™ 
PERICARDIAL BIOPROSTHESES STUDY SUMMARY 
 
Protocol No: 
2007-08 
Study Title 
Carpentier-Edwards Perimount Magna Ease Pericardial Bioprosthesis 
in the Aortic Position, Model 3300TFX 
Study Purpose: 
To evaluate the long term safety and effectiveness of the Carpentier-
Edwards® PERIMOUNT® Magna Ease™ Valves in patients 
undergoing isolated aortic valve replacement.  
Study Device: 
Carpentier-Edwards® PERIMOUNT® Magna Ease™, Model 3300TFX. 
Study Design: 
This is a prospective, single-arm, multi-center 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. 
Study 
Population: 
Male and female patients, 18 years or older, requiring replacement for 
a diseased, damaged, or malfunctioning natural or prosthetic aortic 
valve. 
Entry Criteria: 
Patients will preoperatively sign the patient informed consent form, 
and meet all inclusion criteria and none of the exclusion criteria to 
participate in this clinical study. 
Duration of 
Participation: 
After valve implantation, patients will be followed and assessed at 
discharge, 6-months, one year, and annually thereafter for a minimum 
of 8 years. 
Clinical 
Endpoints: 
Primary Safety  
 
Linearized yearly rates of: 
 Thromboembolism  
 All hemorrhage  
 All perivalvular leak  
 Endocarditis 
Secondary Safety  
Early rates, late linearized rates, and actuarial rates of: 
 
Thromboembolism 
 
Valve thrombosis 
 
All hemorrhage 
 
Major hemorrhage 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
3 
 
 
All perivalvular leak 
 
Major perivalvular leak 
 
Endocarditis 
 
Hemolysis 
 
Structural valve deterioration 
 
Non-structural valve dysfunction 
 
Reoperation 
 
Explant 
 
Death 
 
Valve-related death 
Blood Data 
 
Primary Effectiveness: 
Percent of subjects in NYHA Functional Class I and II at 8 
years post implant. 
 
Secondary Effectiveness: 
Hemodynamic Performance at 8 years post implant: 
 
Peak gradient 
 
Mean gradient 
 
Effective orifice area (EOA) 
 
EOA index 
 
Performance index 
 
Cardiac output 
 
Cardiac index 
 
Severity of aortic regurgitation 
 
 Quality of Life survey (EQ-5D) 
 
Study 
Sponsor: 
Edwards Lifesciences LLC 
One Edwards Way 
Irvine, CA 92614 USA 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
4 
 
 
2. Carpentier-Edwards Perimount Magna Ease Pericardial 
Bioprosthesis in the Aortic Position Study Procedures Chart 
 
 
Assessments 
Required information or 
Procedure 
Pre-op 
Operative 
Discharge 
6-Month 
1 Year, 
annually 
thereafter 
Unscheduled 
visit 
Subject Informed Consent 
X 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
 
Subject Demographics 
X 
 
 
 
 
 
History 
X 
 
 
 
 
 
Diagnosis for Implant 
 
X 
 
 
 
 
Operative Information 
 
X 
 
 
 
 
Implant Data Card 
 
 
X 
 
 
 
Physical Assessment1 
X 
 
X 
X 
X 
X 
Cardiac Rhythm by EKG 
X 
 
 
X 
X 
X 
Antithromboembolic 
Therapies 
X 
 
X 
X 
X 
X 
Coagulation Profile 
X 
 
X 
X 
X 
X 
NYHA Functional Class 
X 
 
 
X 
X 
X 
Echocardiography  
X4 
X2 
X 
X 
X3 
X 4 
Blood Data 
X 
 
 
X 
X 
X 
Adverse Events 
 
X 
X 
X 
X 
X 
Visit / Subject Status 
 
 
X 
X 
X 
X 
QOL 
 
X 
 
 
X 
 
 
 
1 Physical Assessment includes measurement of heart rate, height (initial assessment only), weight and blood 
pressure 
2  If Intra-operative TEE is conducted, echocardiography data should be collected 
3  Full Echocardiography data is required at 1, 5 and 8 Year follow-up visits. 
At 2, 4 and 6 Year follow-up visits, an echocardiography with regurgitation data, if present; ejection fractions, 
gradients EOA, LV Mass and perivalvular leaks.  
4  Optional  

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
5 
 
3. 
INTRODUCTION 
 
Valvular heart disease is a life-threatening disease that afflicts millions of people worldwide and 
leads to approximately 250,000 valve repairs and/or replacements each year [1]. Diseased heart 
valves can be treated by medication, surgical repair and surgical replacement. 
 
The Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis Model 3300TFX is a 
trileaflet valve comprised of bovine pericardium that has been preserved in a buffered glutaraldehyde 
solution and mounted on a flexible cobalt-chromium alloy frame. It is intended for patients who require 
replacement of their diseased, damaged or malfunctioning native or prosthetic aortic valve and 
whose prognosis without aortic valve replacement is unacceptably poor in terms of survival, 
quality of life, or both in the opinion of the attending physicians. 
 
 
 
 
 
 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
6 
4. 
STUDY OVERVIEW 
 
4.1 PURPOSE 
 
The primary objective of the investigation is to obtain long-term human clinical data in order to 
demonstrate that the Carpentier-Edwards PERIMOUNT Magna Ease is a safe and effective 
replacement aortic bioprosthesis. 
 
4.2 ENDPOINTS 
 
4.2.1 PRIMARY SAFETY ENDPOINTS 
 
Long term safety performance will be evaluated by comparing the linearized yearly rates listed 
below to the objective performance criteria (OPC) referenced in the Food and Drug Administration 
(FDA) 1994 Draft Heart Valve Guidance [2]. 
OPC’s from the Heart Valve Guidance are: 
 Thromboembolism 
 All Hemorrhage 
 All Perivalvular Leak 
 Endocarditis 
 
4.2.2 SECONDARY SAFETY ENDPOINTS 
 
Descriptive information of early rates, late linearized rates and actuarial analysis of the following: 
 
Thromboembolism 
 
Valve thrombosis 
 
All hemorrhage 
 
Major hemorrhage 
 
All perivalvular leak 
 
Major perivalvular leak 
 
Endocarditis 
 
Hemolysis 
 
Structural valve deterioration 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
7 
 
Non-structural valve dysfunction 
 
Reoperation 
 
Explant 
 
Death 
 
Valve-related death 
Blood Data (white blood count, red blood count, hematocrit, hemoglobin, platelet count, serum 
lactate dehydrogenase, haptoglobin and reticulocytes). 
 
4.2.3 PRIMARY EFFECTIVENESS ENDPOINTS 
 
The primary effectiveness endpoint will be: 
Proportion of subjects in NYHA Functional Classification I and II at 8 years post-implant.  
 
4.2.4 SECONDARY EFFECTIVENESS ENDPOINTS 
 
The secondary effectiveness endpoints will be:  
Hemodynamic Performance by echocardiography at 8 years post implant, which includes: 
 
Peak Gradient 
 
Mean Gradient 
 
Effective Orifice Area 
 
Effective Orifice Area Index 
 
Performance Index 
 
Cardiac Output  
 
Cardiac Index 
 
Severity of aortic regurgitation 
Quality of Life Survey (EQ-5D) 
 
5. 
STUDY DESIGN 
 
This is a prospective, single-arm, multi-center study to be conducted in the US and outside the US 
(OUS).  A minimum of 225 subjects will be implanted (Section 11.1 Sample Size) to obtain long 
term data from 101 subjects at 8 years post implant of the Carpentier-Edwards PERIMOUNT 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
8 
Magna Ease Pericardial Aortic Bioprosthesis, Model 3300TFX (Magna Ease valve).  Subject 
enrollment will not start in the US before obtaining FDA approval of this post approval study.  
 
5.1. 
STUDY SITE SELECTION 
 
Up to 20 sites will enroll subjects in this study.  Participating sites will be chosen based on their 
experience in conducting clinical studies, their experience implanting bioprostheses, excellent 
academic and medical reputation, as well as their ability to obtain a robust patient population. 
Each of the centers is required to have a study coordinator to assist the primary investigator(s). In 
addition, each participating center must have the time and resources available to participate in this 
study. 
 
Study sites will be in the United States, and outside the US (OUS).  On average, each site is 
expected to implant the Magna Ease valve in at least 15 subjects until enrollment requirements 
are met.  It is anticipated that each of the participating sites will have a Principal Investigator, and 
there will be up to six Co-Investigators per site, for a total of up to 140 investigators. Each of the 
operating investigators will be experienced in aortic valve replacement surgery. 
 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
9 
 
5.2. 
STUDY TIMELINE 
 
Expected timeline for study implementation: 
Table 1: Expected timeline for study implementation 
Study Milestone 
Timeframe in Quarters 
(3 months) 
Cumulative Subject 
Enrollment 
FDA protocol approval 
Q0 
0 
Study Site Start-up 
 
• 1-2 IRB approvals / month 
Q1 – Q3 
(3 months – 9 months) 
40 - 86* 
First subject enrolled 
Q1 – Q2 
(3 months – 6 months) 
87 
Enrollment Phase 
 
• 1-3 subjects / quarter / site 
Q2 
107 
Q3 
123 
Q4 
143 
Q5 
170 
Q6 
194 
Q7 
218 
Completion of Subject Enrollment 
Q8 
225 
Completion of Follow-up 
 
101 subjects complete 
8 year assessment 
 
Final Study Report Submission 
Q1 after last subject 
completes follow-up 
 
* Subjects already enrolled outside U.S. (OUS) 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
10 
6. PATIENT POPULATION 
 
Patients undergoing valve replacement of the diseased native aortic valve or previously implanted 
prosthesis will be considered for this study if they sign the subject informed consent form 
preoperatively, and meet all inclusion criteria and none of the exclusion criteria.  
 
The routine practice of cardiovascular surgery employed by the principal investigator will 
determine the indications for replacement of a patient's natural valve or previously implanted 
prosthesis.  Due to the complexity and variations in surgical procedures, and the individual 
anatomy and other patient related factors, the choice of surgical technique and approach is left to 
the discretion of the individual surgeon. 
 
6.1 ENTRY CRITERIA 
 
Patients will have to preoperatively sign the subject informed consent form, and meet all inclusion 
criteria and none of the exclusion criteria as indicated below to participate in this clinical study.  
The investigator will determine and document whether each patient meets the selection criteria 
before enrollment into the study.  Subjects will be considered enrolled for study participation at the 
time the patient signs the subject informed consent form.  A subject identification number will be 
assigned to each enrolled subject.  If an enrolled subject does not receive the study valve an 
explanation will be indicated on the Case Report Form (CRF).  The subject will be discontinued 
from the study and no further CRFs will be completed for these subjects.  If a non-study tissue 
valve or a mechanical valve is implanted in an otherwise eligible subject, the reason for implanting 
the non-study valve must be documented in the Subject Screening Log.  Reasons for implant of a 
non-study tissue valve in the aortic position include the subject’s refusal to participate, withdrawal 
from the study, etc.  Documentation of these cases is important to prevent bias in subject 
selection.  Subjects censored from the study will be identified and the reason for censorship will 
be indicated. 
 
6.2 INCLUSION CRITERIA 
 
1. The patient requires, as indicated in the preoperative evaluation, a replacement aortic 
valve. 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
11 
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. 
 
6.3 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. 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
12 
7. 
STUDY MATERIALS 
 
7.1. 
DEVICE DESCRIPTION 
 
The Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis Model 3300TFX is 
a trileaflet bioprosthesis comprised of bovine pericardium that has been preserved in a buffered 
glutaraldehyde solution and mounted on a flexible frame. The bioprosthesis is treated according to 
the Edwards ThermaFix® process, which involves heat treatment of the tissue in glutaraldehyde 
and uses ethanol and polysorbate 80. The frame is designed to be compliant at the orifice and 
commissures. The lightweight frame is made of cobalt-chromium alloy , a corrosion-resistant alloy 
chosen because of its superior spring efficiency and fatigue-resistant characteristics, and is 
covered with a woven polyester fabric 
. 
 
A thin cobalt-chromium alloy /polyester film laminate surrounds the base of the wireform frame 
providing structural support for the orifice. A silicone rubber suture ring is attached to the cobalt-
chromium alloy  frame that is covered with a porous, polytetrafluoroethylene cloth to facilitate 
tissue ingrowth and encapsulation. The aortic sewing ring has been scalloped to conform to the 
natural aortic annulus. The compliant nature of the suture ring also facilitates coaptation between 
the bioprosthesis and an often irregular calcified tissue bed. 
 
The original aortic Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis, Model 2700, has 
been commercially available in the US since 1981 and the Model 2900 has been commercially 
available on the international market since 1983, Model 2800 (RSR) has been commercially 
available in the US since 1996 and Model PERIMOUNT Magna 3000TFX has been CE marked 
since 2004 and was launched in the US in 2005.  The aortic Carpentier-Edwards PERIMOUNT 
Magna Ease obtained CE marking in December 2006. 
 
The modifications resulting in Carpentier-Edwards PERIMOUNT Magna Ease Pericardial 
Bioprosthesis, Model 3300TFX is based on the continuing clinical experience in pericardial valves. 
The profile height on the Magna Ease bioprosthesis has been reduced to facilitate implantation in 
patients with small aortic roots. 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
13 
The Model 3300TFX Magna Ease valve is available in the following sizes: 19 mm, 21 mm, 23 mm, 
25 mm, 27 mm and 29 mm. 
 
Pre-Clinical Studies 
 
Pre-clinical bench studies included sewing ring integrity testing, valve hydrodynamic, durability, 
shelf life & packaging, sterility, biocompatibility testing and structural component fatigue analysis. 
The design validation data demonstrate that the Magna Ease valves are designed to perform 
safely and effectively.  
 
8. 
STUDY PROCEDURES 
 
Edwards will provide the study sites with the post approval study clinical protocol, Case Report 
Forms (CRFs, 
), Quality of Life survey 
 and all other necessary study 
related documentation.  Edwards’ Clinical Affairs Department will conduct all aspects of data 
quality assurance (data review and monitoring of study sites) per departmental Standard 
Operating Procedures. 
 
Each study site will adhere to all the requirements specified in this protocol.  Assessments for 
each patient will be obtained for the preoperative and operative visits, and postoperatively at 
discharge, 6-months, 1-year and annually thereafter for a minimum of 8 years (see tables 1, 2, 3 
and 4). 
 
The investigator will make every attempt to follow the subjects and will document the information 
gathered during the above mentioned study visits on the CRFs.  The subjects will be encouraged 
by the investigator to report any address or telephone number changes.  They will also be 
informed of the importance of returning for scheduled follow-up visits even if they are not having 
any problems.  If a subject is lost to follow-up the efforts undertaken to locate the subject should 
be documented. 
 
Each site will provide a list of normal blood values and a certificate, or equivalent documentation, 
outlining the quality level of their laboratory prior to study initiation. 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
14 
8.1 
PREOPERATIVE PROCEDURES 
 
The investigator will determine and record each subject’s demographics (date of birth, sex), 
physical assessment (heart rate, height, weight and blood pressure), New York Heart Association 
(NYHA) functional class, cardiac rhythm, cardiovascular medical history/risk factors, non-
cardiovascular conditions, previous cardiovascular procedures/interventions, anti-thromboembolic 
medications and coagulation profile. 
 
Blood data is required for each subject preoperatively and should be collected within 30 days prior 
to valve replacement.  The following parameters will be collected: white blood cell count (WBC), 
red blood cell count (RBC), hemoglobin, hematocrit, reticulocytes, platelet count, haptoglobin and 
serum lactic dehydrogenase (SLDH).  Should the serum LDH be elevated, it should be 
fractionated.  Preoperative data is indicated on the CRF and is outlined in Table 2.  The 
investigator or designee will also indicate if the parameters are within normal ranges or not and 
whether the change is clinically significant. A QOL survey (EQ-5D) will be completed by the 
subject pre operatively. 
 
In addition, pre-operative echocardiographic evaluation is optional for this study; however if 
performed, the investigator should document the findings. The echocardiography information will 
be indicated on the CRF. 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
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15 
 
Table 2: Preoperative Evaluation 
Clinical information 
Blood Studies 
Echocardiography Data  
Date of Birth 
White Blood Cell Count  
Red Blood Cell Count 
Hemoglobin 
Hematocrit 
Reticulocytes 
Platelet Count 
Haptoglobin  
Serum Lactate Dehydrogenase 
(fractionated, if elevated) 
 
 
Echo Date & Interval 
Reason for Echocardiography 
Echo Variables1 
Cardiac Output Calculation 
LV Measurements2 
Transducer Position 
Peak & Mean Gradients Method 
Stenosis 
Regurgitation 
LV Structure/Function 
 
Sex 
Physical Assessment 
 
Heart Rate 
 
Height (cm) 
 
Weight (kg) 
 
Blood Pressure (mmHg) 
 
NYHA Functional Classification 
Antithromboembolic Therapy 
Cardiac Rhythm by EKG 
Cardiovascular Medical 
history/Risk Factors 
Cardiovascular Conditions (past 
and present) 
Previous Cardiovascular 
Operations 
Non Cardiovascular Conditions 
past and present) 
Coagulation Profile 
QOL survey 
 
 
8.2 
OPERATIVE PROCEDURES 
 
The surgical technique employed will be that developed and perfected by the Investigator in his or 
her normal practice of cardiac surgery.  Special attention should be given to proper sizing, 
                                            
1Echo Variables include: VpeakLVOT, VpeakAO, Peak systolic gradient, mean systolic gradient, Stroke 
volume, cardiac output, LVOT diameter, TVILVOT, TVIAO, ejection fraction, aortic EOA).   
2  LV Measurements include: LV Mass and LV Mass Index. 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
16 
orientation and irrigation of the valve during surgery as indicated in the Instructions For Use (IFU) 
. 
 
The investigator will record the implant date, implanting surgeon, etiology, diagnosis for current 
replacement, information regarding the particular valve implanted (including valve size, serial 
number, valve position, suture technique, whether pledgets were used or not) and other details 
concerning the surgery such as condition of the valve being replaced, condition of the annulus, 
debridement procedures, annulus diameter (Hegar sizer) after debridement procedure, surgical 
approach, concomitant procedures and intra-operative adverse events.  
 
An intra-operative echocardiographic evaluation is not required for this study, however if 
performed, the echocardiography information will be indicated on the CRF. 
 
Table 3: Operative Evaluation 
Clinical information 
Date of Implant 
Implanting Surgeon 
Etiology 
Diagnosis for Valve Replacement 
Total Cross clamp time 
Pump Time 
Surgical Approach 
Condition of the Annulus 
Placement of Valve 
 
Study valve  
Valve Size 
Serial number 
Suture technique 
Condition of the Valve being replaced 
Debridement procedure  
Tissue Annulus Diameter of Subject (Hegar sizer) 
Concomitant procedures 
Intra-operative Adverse Events 
Seating the Valve in Annulus 
Valve Position 
Pledgets 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
17 
8.3 
POSTOPERATIVE PROCEDURES 
 
8.3.1 DISCHARGE 
 
At discharge, the investigator or designee will provide the subject with an Implant Data Card (See 
Section 17.4 and 
.  The Implant Data Card must be filled with the required information 
(I.e., the name of the investigator, the contact information and the name of the facility).  The 
investigator or designee should also obtain from the device package two stickers with the 
implanted Magna Ease serial number and affix one sticker on the back of the Implant Data Card 
and the second sticker on the front page of the subject’s operations notes.  In addition, the 
investigator or designee must explain to the subject the purpose of this Implant Data Card. 
 
The investigator or designee will record the subject’s status, physical assessment date, cardiac 
rhythm, anti-thromboembolic therapy, coagulation profile, and adverse events on the CRF.  
Echo/Doppler evaluation is required early postoperatively (within 30 days from implant date) or at 
discharge whichever comes first (Echo CRF).  The requested clinical and echocardiographic 
variables at discharge are outlined below. The echocardiography information will be indicated on 
the CRF. 
Table 4: Postoperative Evaluation at Discharge 
Clinical information 
Echocardiography Data (TTE) 
Subject status 
 Physical Assessment: 
Heart Rate 
Weight (kg) 
Blood Pressure (mmHg) 
 
Cardiac Rhythm 
Anti-Thromboembolic Therapy  
Coagulation Profile 
Adverse Events 
Provide subject with Implant Data Card 
Echo Date & Interval 
Reason for Echocardiography 
Transducer Position 
Echo Variable3  
LV Measurements4 
Stenosis 
Regurgitation 
LV Structure/Function 
                                            
3 Echo Variables include: VpeakLVOT, VpeakAO, Peak systolic gradient, mean systolic gradient, Stroke 
volume, cardiac output, LVOT diameter, TVILVOT, TVIAO, ejection fraction, aortic EOA).  
4  LV Measurements include: LV Mass and LV Mass Index 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
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disclosed without written permission from Edwards Lifesciences LLC. 
 
18 
8.3.2 POSTOPERATIVE FOLLOW-UP VISITS 
 
Post operative follow-up visits are required at 6 months, 1 year, and annually thereafter for a 
minimum of 8 years.  In addition to the requested data at discharge, the New York Heart 
Association (NYHA) functional class will be assessed at subsequent postoperative assessments 
at 6-months (between 3-6 months) and annually post implant (± 1 month of annual follow-up 
evaluations).  
 
Postoperative blood studies are also required at 6- months (between 3-6 months), Blood data will 
support the absence/presence of related adverse events; in particular hemolysis.  Should the 
serum LDH be elevated, it should be fractionated.  The investigator or designee will also indicate if 
the parameters are within normal ranges or not and whether this poses a clinically significant 
event.  The investigator will document all clinically significant events by completing the appropriate 
adverse event CRF.  
 
Full Doppler/echocardiography is required for all subjects at 6-months (between 3-6 months) at 1, 
5 and 8 year follow-up visits. At 2, 4 and 6 year follow-up visits, an echocardiography with 
regurgitation data, if present; ejection fractions, gradients, EOA, LV Mass and perivalvular leaks 
will be obtained. The echocardiography information will be indicated on the CRF. The investigator 
will document all clinically significant regurgitation and stenosis that need intervention by 
completing the appropriate adverse event CRF.  
 
A QOL survey (EQ-5D) will be completed by the subject preoperatively and at the 6-month follow-
up visit.   
 
The assessment of cardiovascular adverse events will be conducted in accordance with the 
revised “Guidelines for Reporting Morbidity and Mortality after Cardiac Valvular Operations” (STS 
guidelines) published by the Society for Thoracic Surgeons (STS) in September 1988 [3]
and revised in 2008 [4] 
.  All pertinent details related to the adverse event and 
evaluation of valve relatedness will be completed in accordance with the revised STS guidelines.  
In reporting adverse events, the clinical investigator will assess all cardiovascular related 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
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disclosed without written permission from Edwards Lifesciences LLC. 
 
19 
symptoms including abnormal heart murmur, shortness of breath, exercise intolerance, dyspnea, 
orthopnea, anemia, fever, arrhythmia, transient ischemic attack, stroke, paralysis, low cardiac 
output, pulmonary edema, congestive heart failure and myocardial infarction as to their relation to 
the valve and will complete the appropriate adverse event data form as needed.   
 
The investigator will record adverse events on the adverse event CRF.  The different adverse 
event CRFs are designed to capture relevant information for thromboembolism, valvular 
thrombosis, non-structural valve dysfunction, structural valve deterioration, bleeding events, 
endocarditis, hemolysis and all other adverse events respectively.  Perivalvular leaks will be 
captured as part of the non-structural valve dysfunction adverse event data form.  The 
outcome/resolution status of the adverse event will also be indicated as part of the adverse event 
data form.  If an event results in death, copies of the autopsy report and/or death summary must 
be sent to Edwards, as permitted by local laws.  Details of expiration and re-operation / explant 
data will be documented on CRFs.  The investigator will make every effort to return the explanted 
valve(s) (at autopsy or explantation) to Edwards (Section 10.5). 
 
It is recommended to maintain bioprosthetic heart valve recipients on anticoagulant therapy during 
the initial healing stages after implantation (approximately two to three months) except where 
contraindicated.  The appropriate anticoagulation therapy must be determined by the physician on 
an individual basis and based on current ACC/AHA guidelines [5].   
 
At each postoperative assessment, the investigator should determine the subject's availability for 
future follow-ups.  The requested clinical, blood data and echocardiography variables 
postoperatively are collected on the CRFs provided and are outlined in Table 5 below. 
 
 
 
 
 
 
 
 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
20 
 
 
 
Table 5: Postoperative Evaluations (6 Month, 1 Year, Annual) 
Clinical information 
Blood Studies 
Echocardiography Data Ŧ  
Date of Assessment 
Follow-Up Interval 
Visit Status 
Subject Status 
Physical Assessment: 
     Heart Rate 
     Weight (kg) 
     Blood Pressure (mmHg) 
Cardiac Rhythm by EKG 
NYHA Functional Class 
Anti-thromboembolic Therapy 
Coagulation Profile 
QOL Survey* 
Adverse Events 
White Blood Cell Count 
Red Blood Cell Count 
Hemoglobin 
Hematocrit 
Reticulocytes 
Platelet Count 
Haptoglobin 
Serum Lactate Dehydrogenase 
(fractionated, if elevated) 
Coagulation profile 
 
Echo Date & Interval 
Reason for Echocardiography 
Echo Variables5 
 
LV Measurements6 
 
Transducer Position  
Peak & Mean Gradients  Method 
Stenosis 
Regurgitation 
LV Structure/Function 
 
* At the 6-month follow-up visit only. 
Ŧ  Full Doppler echo was required at 6 months, 1, 5 and 8 years and a more limited study at 2, 4 
and 6 years. 
 
8.3.3 UNSCHEDULED VISIT 
 
If any subject needs to be seen at other than a regularly scheduled follow-up visit for assessment 
of cardiac symptoms, the obtained information will be documented by the investigator on the CRF 
and follow-up interval is indicated as an “Other” visit.  If blood studies are performed at these visits 
in response to symptoms, the investigator should document these studies on the CRF.  Should 
the serum LDH be elevated, it should be fractionated.  Doppler/echocardiography performed at 
these visits is optional, however if performed, the investigator should record echo parameters on 
the echo CRF.  The echocardiography information will be indicated on the CRF. 
                                            
5 Echo Variables include: VpeakLVOT, VpeakAO, Peak systolic gradient, mean systolic gradient, 
Stroke volume, cardiac output, LVOT diameter, TVILVOT, TVIAO, ejection fraction, aortic EOA).  
6  LV Measurements include: LV Mass and LV Mass Index. 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
21 
9. 
RISKS AND BENEFITS 
 
The subjects for whom this device is intended are those seriously or critically ill whose prognosis 
without surgery for replacement of the diseased natural valve or previously implanted prosthesis is 
unacceptably poor in terms of survival, quality of life, or both in the opinion of the attending 
physicians.  For this special subset of patients there are a number of widely accepted prosthetic 
heart valves in common use; however, none are without risk of serious complications related to 
thrombogenicity, hemodynamics, and durability. 
 
Patients with mechanical valves are generally considered to have a serious threat of 
thromboembolic complications unless they are on an adequate anti-thromboembolic therapy.  
Even with adequate anti-thromboembolic therapy, the risk of complications is significant, 
particularly when the risk of serious hemorrhage is considered. Bioprostheses, on the other hand, 
pose a reduced risk of thromboembolism and serious hemorrhage since they do not require anti-
thromboembolic therapy. 
 
Although the proven longevity of bioprosthesis is not as extensive as for some of the currently 
available mechanical valves, Banbury et al. [6] reported on the durability of the Carpentier-
Edwards PERIMOUNT Pericardial Bioprosthesis, Model 2700, in the aortic position. The mean 
age of this patient population at implant was 65  12 years. The risk-unadjusted freedom from 
structural valve deterioration was 77.0% at fifteen years [4]. A study conducted by Frater et al [7] 
on a patient cohort of 267 patients reported the valve related survival rate was 78.8%  3.2% and 
overall freedom from explant due to valve dysfunction was 85.1%  3.0% at 14 years [5]. Freedom 
from valve failure was 68%  12% at 18 years in a study conducted by Aupart [8] et al. with the 
Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis. Among patients > 60 years, the 
actuarial freedom of valve failure at 18 years was 85%  8% [6].  
 
As with any patient undergoing heart valve replacement, patients in this study may experience 
adverse events which may include, but are not limited to, the following: angina, hemorrhage, 
arrhythmia, cardiac arrest, endocarditis, heart failure, hemolysis, myocardial infarction, prosthesis 
pannus, (non)-structural valve dysfunction, perivalvular leak, stenosis, stroke, regurgitation, 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
22 
reoperation or explant, thromboembolism, valve thrombosis and/or death.  All cardiovascular 
adverse events will be evaluated in relationship to the valve using the revised STS guidelines [3]  
. 
 
No procedures in this study are experimental. Participating in this study is thought not to induce 
any additional risk to patient undergoing aortic valve replacement. 
 
10. CLINICAL ADVERSE EVENTS 
 
10.1 OVERVIEW AND DEFINITIONS  
 
Adverse events associated with Magna Ease valve will be recorded and analyzed. An appropriate 
adverse event data form will be completed as per revised STS guidelines 3] 
 and 
submitted to Edwards. 
 
Consideration of Adverse Events will hereafter consist of Adverse Events and Adverse 
Device Effects, including Serious Adverse Events, Serious Adverse Device Effects, 
Anticipated Adverse Device Effects, and Unanticipated Adverse Device Effects.  
 
Adverse Event (AE):   
Any unfavorable and/or unintended sign symptom, or disease, temporally associated with 
the use of a device product, whether or not the event is considered related to the device 
product. 
 
Adverse Device Effects (ADE):  
An untoward or unintended response to the device.  This definition includes any event 
resulting from insufficiencies or inadequacies in the Instructions For Use or the deployment 
of the device or any event that is a result of user error. 
 
Anticipated Adverse Device Effect (AADE):  
Any adverse effect related to the device, which is identified in the protocol prior to study 
commencement. 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
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23 
 Serious Adverse Event (SAE):  
Includes any of the following events that may or may not be considered related to the 
device. 
 Death due to any cause 
 Life threatening or permanently disabling events 
 Any event resulting in additional treatment (intervention to prevent permanent 
impairment/ damage), hospitalization or prolonged hospitalization 
 
Hospitalization for diagnostic or elective surgical procedures for a pre-existing condition is 
not considered an SAE 
 
Serious Adverse Device Effect (SADE): 
Adverse Device Effect that resulted in any of the consequences characteristics of a SAE or 
that might have led to any of these consequences if suitable action had not been taken or 
intervention had not been made or if circumstances had been less opportune. 
 
Unanticipated Adverse Device Effect (UADE):   
Any SAE on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in 
nature, severity or degree of incidence in the protocol or application (including a 
supplementary plan or application) or any other unanticipated serious problem associated 
with a device that relates to the rights, safety, or welfare of subjects.  
 
The occurrence of any UADE must be reported to Edwards within 2 business days of 
discovery by the investigator or his or her designee  
 
10.2 ADVERSE EXPERIENCE REPORTING 
 
The investigator(s) shall report any device related adverse event and any unexpected adverse 
device effect occurring during the study to the sponsor within 24 hours; submit a written summary 
of the event to the Heart Valve Therapy Clinical Affairs department either via email to  
HVTClinicalResearch@edwards.com, or by fax to +1-949-809-5610.  Edwards will report the 
event according to the country specific regulations and respective reporting requirements The 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
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disclosed without written permission from Edwards Lifesciences LLC. 
 
24 
Investigator is responsible for notifying their Institutional Review Board / Ethics Committee (IRB 
/EC).  
 
10.3 MEDICAL DEVICE REPORTING (MDR) 
 
The Sponsor will be responsible for reporting events to the Food and Drug Administration in 
accordance with 21 CFR 803 Medical Device Reporting.  Examples of MDR events include the 
Safety Endpoints listed in section 4.2.1 and section 4.2.2.  
 
10.4 AUTOPSY/DEATH 
 
Copies of the autopsy report and/or death summary must be sent to Edwards as permitted by 
local laws. This information should be redacted at the site to remove any identifying information 
(i.e. subject full name, personal identification numbers, address, etc.).  Information on the cause of 
death and valve relatedness will be evaluated by the Principal Investigator.  
 
Deaths which must be reported to Edwards Clinical Affairs Department include: 
 
All deaths while participating in the study. 
 
All deaths up to 30 days post study valve explantation. 
 
10.5 EXPLANTED VALVES 
 
Every effort should be made to return the explanted valve(s), at autopsy or explantation to 
Edwards.  The explanted valve should be placed in a container with a suitable histological fixative 
such as 10% formalin or 2% glutaraldehyde immediately after excision and returned to Edwards.  
Refrigeration is not necessary under these circumstances.  Contact Edwards Clinical Research for 
additional instructions. 
 
Any pertinent information, e.g. operative notes, autopsy report etc should be sent to Edwards.  
This information should be redacted at the site to remove any identifying information (i.e. subject 
full name, personal identification numbers, address, etc.). 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
25 
After the study valve is explanted, the subject will be followed for either an additional 30 days to 
monitor for any new adverse events or until all study device related serious adverse events (see 
section 9.1) are resolved.  After that point the subject will be discontinued from the study.  No 
further evaluations and/or case report forms are needed after study exit.  Data from these subjects 
will be included in analysis. 
 
10.6 PATIENT WITHDRAWAL 
 
The investigator should make every attempt to follow the patient at each of the required 
assessment periods.  This information needs to be indicated on the CRF.  Patients may withdraw 
from the study without penalty or loss of benefits to which they are otherwise entitled.  A study 
patient that has been withdrawn from the study will not be replaced.   
 
10.7 MISSED VISIT/ LOST TO FOLLOW-UP 
 
If a subject cannot be reached for a follow-up visit, the investigator will document on the, CRF, the 
efforts undertaken to contact the subject or the subject’s primary health care provider.  These 
efforts should include 3 attempts of telephone contacts at separate dates and times, and a 
registered letter before the end of the follow-up window. If a subject cannot be reached for the 
follow-up visit and misses the scheduled visit, the visit will be recorded as a missed visit on the 
date of last attempted contact.  At the next visit interval, the investigator and/or designee will 
attempt to contact the subject again for follow-up.  Should this attempt to contact the subject fail, a 
family member should be contacted in addition to the subject.  Subjects who miss 2 sequential 
follow-up visits will be considered lost to follow-up at the second missed visit and exempt from 
future study follow-up visits.  After the subject is terminated from the study, the investigator will 
attempt to determine if the subject is alive; including searching national mortality registries when 
available and as permitted by local laws.  
 
11. STATISTICAL ANALYSIS 
 
11.1 SAMPLE SIZE 
 
Sections 11.1 – 11.3 detail the sample size calculation for the trial as well as the analysis 
approach for each of the study outcomes.  Sections 11.4 and 11.5 address the issues of data 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
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disclosed without written permission from Edwards Lifesciences LLC. 
 
26 
poolability and missing data.  Unless otherwise noted, all statistical tests will be performed at 0.05 
level. 
The sample size calculation for the trial is based on the primary safety endpoints.  The linearized 
yearly rates for thromboembolism, all hemorrhage, all perivalvular leak, and endocarditis will be 
compared to the OPC provided in FDA’s Replacement Heart Valve Guidance.  These OPC are 
presented in Table 6. 
Table 6: Safety OPC 
Adverse Event 
OPC 
Thromboembolism 
2.5 
All Hemorrhage 
1.4 
All Perivalvular Leak
1.2 
Endocarditis 
1.2 
More specifically, a statistical test based on the Poisson [9] distribution will be performed for each 
of these adverse event rates to evaluate whether it is less than 2 times the appropriate OPC.  
Thus, the null and alternative hypotheses for each adverse event are as follows: 
H0: λ ≥ 2·OPC 
HA: λ < 2·OPC 
where λ is the linearized yearly rate for the given adverse event (thromboembolism, valve 
thrombosis, all hemorrhage, all perivalvular leak, and endocarditis) computed when the total 
subject years reaches 808 and OPC denotes the relevant OPC.  The test statistic for each 
adverse event is of the form: 




OPC
Z



2
. 
H0 is rejected in favor of HA if Z is less than -1.645, the lower 5% percentile of the standard normal 
distribution.  Grunkemeier, et al. [10] have demonstrated that 800 subject life-years is adequate to 
test against the smallest OPC of 1.2% per subject year (excluding valve thrombosis, and 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
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disclosed without written permission from Edwards Lifesciences LLC. 
 
27 
stratification for major versus minor hemorrhage, and perivalvular leak) with Type I and Type II 
error controlled at the .05 and .20 levels, respectively.   
The proposed subject enrollment is calculated to ensure that at least 101 subjects survive to 8 
years post implant.  These 8*101 = 808 life years in addition to the life years from those subjects 
not surviving to 8 years will more than fulfill the 800 life-years required by Grunkemeier, et al [10]. 
Sample size calculation for primary effectiveness endpoint is based on a test of the hypothesis: 
H0: p ≤ 75% 
HA: p > 75% 
where p is the proportion of the subjects in NYHA Class I or Class II at 8 years post implant. The 
expected proportion of the alive subjects in NYHA class I or II at eight years is above 90%, based 
on 8 year follow up data for the Carpentier-Edwards PERIMOUNT 2700/2800/2900 valve (this 
proportion is above 90% within the subjects with valid NYHA assessment at each annual visit till 8 
years follow up).  Based on this expected proportion, a sample size of 45 subjects provides 85% 
power to test the hypothesis that the true proportion is greater than 75% using an exact binomial 
test.  Thus, the sample size of 101 subjects with NYHA data at 8 year post implant is more than 
adequate to provide sufficient power. 
The calculated number of subjects (n) that must be enrolled in order to have 101 subjects survive 
to 8 years post implant with 99% probability is based on the binomial distribution.  Specifically, n is 
such that 


%
99
1
1
101
1











x
n
x
x
p
p
x
n
 
where p is the probability that a subject will survive for 8 years post implant.  This calculation can 
be performed using standard statistical software.  Based on the reported 8-year survival of 60% 
from Aupart, et al. (2006) [8], a sample size of 195 subjects fulfills the requirements of the 
equation above.  Based on the data collected in a previous post approval study conducted by 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
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disclosed without written permission from Edwards Lifesciences LLC. 
 
28 
Edwards (Study 98-1), a lost to follow-up rate of 7.8% was observed among subjects who reached 
5 or more years of follow-up post implant.  The sample size is further inflated to 225 to account for 
up to a 15% rate of lost to follow up.  
 
11.2 ANALYSIS POPULATION 
 
All the data collected up to the point of the explant or expirations will be included in the safety and 
effectiveness analyses.  The primary safety analysis will include all the enrolled subjects.  The 
primary effectiveness analysis will include the subjects who survived post implant and have at 
least one post-implant NYHA assessment.  
 
11.3 SAFETY ANALYSIS 
 
11.3.1   PRIMARY SAFETY ENDPOINT 
 
As described above a statistical test based on the Poisson distribution will be performed to 
investigate whether the linearized yearly rate for each cardiovascular adverse event 
(thromboembolism, all hemorrhage, all perivalvular leak, and endocarditis) is less than 2 times the 
appropriate OPC from the 1994 Draft Heart Valve guidance. 
 
For reporting purposes, the percent of subjects who experience an early adverse event within 30 
days of implant will be summarized.  Linearized rates will be used to summarize adverse events 
for the late (>30 days) post-operative period.  The linearized rates will be reported as the number 
of events occurring after the early post-operative period per year of subject survival.  In addition, 
the linearized rate and 30-day frequency for thromboembolism will be stratified by concomitant 
cardiac problems (atrial fibrillation, sinus rhythm, pacemakers, etc.). 
 
Accounting for both early and late post-operative events, actuarial analysis according to Kaplan-
Meier will be used to show estimated probability of freedom from each adverse event.   
 
11.3.2   SECONDARY SAFETY ENDPOINTS 
 
Blood Data 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
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disclosed without written permission from Edwards Lifesciences LLC. 
 
29 
Blood data (red blood count, white blood count, hematocrit, hemoglobin, platelet count, serum 
lactate dehydrogenase, haptoglobin, and reticulocytes) will be collected preoperatively, at 6-
months and annually post implant.  This blood data will support the absence / presence of related 
adverse events; in particular hemolysis.  Data will be reported as the percent of subjects with 
results within the normal ranges at each time interval.  The percent of subjects with hemolysis at 
each point will also be reported.  Summaries will be presented for the entire study cohort and will 
also be stratified by valve size.    
 
Time to Death, Reoperation, and Explant 
 
Time to death from the date of operation will be analyzed by the method of Kaplan and Meier.  
Time to reoperation from the date of operation as well as time to explant from the date of 
reoperation will be similarly analyzed.  For time to explant and time to reoperation, the time to first 
explant or reoperation will be calculated for those subjects requiring explant or reoperation.  
These analyses will also be reported stratified by valve size.  Analyses for time to explant and 
time to reoperation will also be stratified by fatal versus non-fatal events.   
 
Nonstructural Valve Dysfunction and Structural Valve Deterioration 
 
The percentage of subjects experiencing nonstructural valve dysfunction and structural valve 
deterioration within the early post-operative period (within 30 days of implant) will be reported.  
Linearized rates will be used to summarize nonstructural valve dysfunction and structural valve 
deterioration for the late (>30 days) post-operative period.  The linearized rates will be reported as 
the number of nonstructural valve dysfunctions and structural valve deteriorations occurring after 
the early post-operative period per year of subject exposure.  The 30-day frequency and 
linearized rate for nonstructural deterioration and structural dysfunction will be stratified by the 
nature of the dysfunction. 
 
11.4 EFFECTIVENESS ANALYSIS 
 
Subject functional classification 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
30 
Subjects will be stratified according to the NYHA classification preoperatively, at 6 months and 
annually post implant for 8 years.  The distribution (numbers of subjects and percentages) in the 
various NYHA classes will be tabulated at each follow-up interval.   
 
The primary effectiveness analysis will include all the subjects who survived the implant procedure 
and have at least one post-implant NYHA assessment. The proportion of the subjects in NYHA 
Classes I and II at 8 years post implant will be calculated to determine if it is ≥ 75% using a one-
sided Binomial exact test.  For subjects who die, withdraw or are lost to follow-up before reaching 
the 8 year follow-up visit, the last observed NYHA classes will be used in this analysis.  As a 
consequence, those subjects will be counted as failures if they were in NYHA Classes III or IV at 
the time those events occurred. Subjects whose status at the time of the events is not known will 
be counted as failures if they were in NYHA Classes III or IV during their last assessment prior to 
the time of the events. 
 
The proportion of subjects in NYHA Classes I and II and proportion of subjects who died and were 
in NYHA Classes III and IV at death or at their last known NYHA classification will also be 
calculated at each annual report.  
 
 
Hemodynamic Performance 
 
Echocardiography data will be obtained preoperatively, early postoperatively and/or discharge, at 
6-months and at 1, 5 and 8 year follow-ups.  Descriptive statistics for the continuous echo 
variables and change from baseline (e.g. mean, standard deviation, and range) will be 
categorized by time interval and size.  Regurgitation data will be summarized using frequency at 
each severity level. 
 
Improvement in regurgitation at one year will be analyzed via the Jonckheere-Terpstra [11] test.  
Change at one year from baseline for all other hemodynamic outcomes will be analyzed using 
paired t-tests. 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
31 
11.5 POOLABILITY 
 
Subject baseline risk will be statistically compared between centers and regions (i.e. United States 
vs. OUS).  Chi-square tests will be used to compare categorical risk factors while analysis of 
variance will be used to compare continuous risk factors.  Comparisons will be based on the 
following demographic and pre-operative variables: age, sex, etiology, previous heart valve 
replacement surgery, valvular lesion, pre-operative NYHA, concomitant cardiac procedures, and 
coexisting cardiovascular conditions.  Also included in the analysis will be the size of implant.  
Furthermore, time to event for the following events will be compared between centers via a log-
rank statistic: thromboembolism, all hemorrhage, death or explant, and death.  Additional 
analyses may be performed if the need arises. 
 
11.6 MISSING DATA 
 
All statistical tests on the effectiveness endpoints will be performed in two ways: (1) using only 
those subjects with available required for endpoint analysis and (2) by using the method of last 
observation carried forward (LOCF).  Both methods of analyses will then be compared.  However, 
both methods will be used for the comparison of NYHA classification at 8 year post implant to 
OPC (75%) and for the comparison of hemodynamic performance one year to baseline for the 
purpose of investigating the effect of loss-to-follow-up.   
 
NYHA classification and hemodynamic performance will be summarized at each of the follow-up 
interval.  In addition, the NYHA classification will only be statistically compared to OPC at 8 years 
post implant and only the one year post implant hemodynamic performance will be statistically 
compared to baseline. 
 
12. ETHICAL AND REGULATORY CONSIDERATIONS 
 
The following must be observed in order to comply with the sponsor's policy for conduct and 
monitoring of clinical investigations; they also represent sound research practice. 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
32 
A written subject informed consent form will be obtained preoperatively from all subjects.  The 
subject must be adequately informed of his or her participation in the clinical study and what will 
be required of him or her in order to comply with the protocol requirements.  In addition, a subject 
informed consent form is required to allow appropriate data collection and data monitoring 
including access to medical records by the sponsor and regulatory agencies 
. 
 
If an Institutional Review Board (IRB) or Ethics Committee (EC) exists for an institution, this 
board/committee must approve the subject informed consent form and protocol for use at its 
institution.  A written statement by the IRB / EC indicating approval of the subject informed 
consent form and protocol must be submitted to the sponsor prior to study initiation. 
 
13. HEALTH ECONOMIC INFORMATION 
 
In the United States only, the Sponsor may choose to obtain billing information such as charges 
associated with the Intensive Care Unit (ICU) and hospital stays to evaluate hospital costs for the 
initial implant hospitalization and subsequent readmissions, as necessary. For each subject, 
hospital charge data will be obtained from form UB-04 or similar report provided by the hospital. 
 
14. CASE REPORT FORMS 
 
CRFs for individual subjects will be provided by Edwards 
.  The principal investigator 
or designee must keep a separate log of subject names and current addresses to facilitate record 
keeping and his or her ability to contact subjects for future follow-up. 
 
CRFs are used to record study data and are an integral part of the study and subsequent reports.  
Therefore, the reports must be legible and complete.  In order to comply with the HIPAA 
regulations and European data protection laws, any information related to the subject’s identity 
must be redacted.  All forms should be filled out using a ballpoint pen.  Errors should be corrected 
by drawing a single strikethrough in ink, initialed and dated by the person who makes the change 
on the day the change is made.  Copies of the changed form must be provided to the sponsor and 
retained in the subject study file. 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
33 
A CRF must be completed and signed by the principal investigator, co-investigator or his or her 
designee listed in the Delegation of Authority form for each subject receiving a study valve, 
including subjects withdrawn from the study for any reason.  The reason for withdrawal must be 
noted on the CRF, by the investigator. 
 
Since there is a potential for errors, inaccuracies, and illegibility in transcribing data onto CRFs, 
originals or photocopies of all relevant operative records and reports, postoperative examinations, 
laboratory and other test results must be kept on file.  CRFs and copies of test results must be 
available at all times for inspection by the study sponsor, the study monitor, and authorized 
regulatory bodies. 
 
CRF’s must be kept current to reflect subject status at each phase during the course of the study.  
Instructions for CRF collection or submission are provided in the CRF synopsis. 
 
Electronic data capture (EDC) may be used for part or all of the data collection in this study.  
Edwards will provide training in the use of EDC to all necessary site personnel.  Each investigator 
and staff participant will be assigned a unique password and only that individual should access 
subject records under that password.  Changes made to the electronic record after a report has 
been saved or “committed” will be tracked in an electronic audit file linked to the date the change 
was made and the password of the individual who opened the record.  Regardless of the type of 
CRF used, the sponsor will monitor subject CRFs for agreement with source documents on an 
ongoing basis. 
 
  

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
34 
15. STUDY TERMINATION 
 
The principal investigator will be notified in writing upon termination of the study. Edwards retains 
the right to suspend or terminate this clinical investigation at any time. 
 
16. RECORD RETENTION 
 
Study files must be maintained at the clinical site for a minimum of two years after the study is 
either completed or terminated or until Edwards notifies the investigator that the records may be 
destroyed or in accordance with country specific regulations. 
 
17. STUDY RESPONSIBILITIES 
 
17.1 INVESTIGATOR RESPONSIBILITIES 
 
The principal investigator is responsible for obtaining IRB/EC approval for the study at his or her 
institution. 
 
Study records including CRFs, signed Agreement, originals of all blood and hemodynamic 
studies, signed informed consents, a copy of the implant data card, IRB/EC approval letters, the 
log of IRB/EC submissions, and other documents pertaining to the conduct of the study should be 
kept on file by the investigator. 
 
The investigator(s) will adhere to the regulations that provide the greatest protection to the 
subject.  The investigator is responsible to comply with the following regulations: 
 US Code of Federal Regulations: 
 
21 CFR part 50: Protection of Human Subjects 
 
21 CFR part 54: Financial Disclosure 
 
21 CFR part 56: Institutional Review Boards 
 
21 CFR part 814, subpart E: Post Approval Requirements 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
35 
In Europe, EU Medical Device Vigilance System 
and the: 
 
ICH Good Clinical Practice Guidelines 
 
Declaration of Helsinki 
 
US Department of Health and Human Services: Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) 
 
Local and Regional Laws of the Country including Data Protection and ISO 14155 
Part 1 and 2: 2003 Clinical Investigation of Medical Devices for Human Subjects, 
where appropriate for commercially available products 
 
All protocol deviations must be fully documented and explained on the CRF. These include 
noncompliance related to inclusion/exclusion criteria, consent form, blood data, echo and follow-
up visits. 
 
Although the risks to the subject are felt to be the same as those reported for other available 
bioprostheses, the subjects receiving the Magna Ease valve will be closely followed.  Any unusual 
or unanticipated adverse events will be reported immediately to the sponsor (see 10.1) and if 
applicable, to the IRB/EC as outlined in the Investigator's Statement and Agreement.  If deemed 
necessary by the investigator, the IRB/EC, or the sponsor, the investigation may be suspended 
pending a thorough study of the incident. 
 
If the investigator wishes to assign the files to someone else or move them to another location, he 
or she should consult with the sponsor in writing as to this change.  If there is a change or addition 
of co-investigators, an amended agreement must be completed promptly.  Any other personnel 
changes should be reported immediately to the monitor and a training program scheduled. 
 
Monitoring visits will be scheduled throughout the course of the study.  It is essential that the 
investigator set aside a sufficient amount of time for these visits to permit an adequate review of 
the study's progress, completed CRFs and original records. 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
36 
17.2    SPONSOR/ STUDY MONITOR RESPONSIBILITIES 
 
A study monitor assigned to the study by the sponsor will monitor the progress of the study.  The 
study monitor must be acquainted with the investigator and other key people involved in the study.  
The study monitor will remain in close contact with the site throughout the duration of the study to 
answer any questions and provide any needed materials, e.g. CRFs.  
 
The study monitor will be responsible for monitoring CRFs and visiting the site periodically to 
monitor study progress and compliance with the study protocol.  The local data protection laws will 
be followed. Monitoring visits will be scheduled throughout the duration of the study at a mutually 
convenient time for the monitor and principal investigator or designee.  
 
The sponsor will provide results of the ongoing study to the Food and Drug Administration, 
including a comparison to the available data in the heart valve literature regarding other FDA-
approved bioprosthetic valves implanted in the aortic position.  An Interim Post-Approval Study 
Status Report will be submitted every 6 months during the first two years of the study and 
annually thereafter.  A Final Clinical Study Report will be prepared as early as 3 months after the 
last study subject completes follow-up. 
 
17.3 STUDY CHANGES 
 
Changes in the protocol may be made only by written amendment submitted to and agreed upon 
by FDA.  Following written approval of a protocol amendment by FDA, the sponsor will submit the 
amended protocol and associated document to the IRB/EC.  The above changes shall be 
implemented upon written approval by the respective IRB/EC.  Administrative changes may be 
communicated to FDA and to the IRB/EC via the Annual Report. 
 
17.4 IMPLANT DATA CARD 
 
After implantation, subjects will be given the Implant Data Card by the Investigator prior to 
discharge 
.  This identification card allows subjects to inform healthcare providers 
what type of implant they have when they seek care.    
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. E: September 15, 2009 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used or 
disclosed without written permission from Edwards Lifesciences LLC. 
 
37 
17.5 STUDY PUBLICATION  
 
Investigators shall submit to Edwards early drafts of all abstracts, manuscripts or presentations 
authored by investigators and collaborators based on data generated from the clinical study at 
least sixty days prior to submission of the abstract, manuscript for publication or presentation.  
Edwards shall have the right to advise investigators regarding proprietary information which shall 
not be divulged or the patentability of any inventions disclosed in the manuscripts.  If requested by 
Edwards, investigators shall delay submission of manuscripts for publication up to ninety days to 
permit preparation and filing of related patent applications.  In addition, Edwards shall have the 
right to require that any publication concerning the work performed hereunder acknowledges 
Edwards' financial support. 
 
It is understood, however, that no press releases, literature, advertising, publicity, or written 
statements in connection with work under the Clinical Studies Agreement having or containing any 
reference to Edwards shall be made by the clinical site and/or the investigator without the prior 
written consent of Edwards.  The clinical site and the investigator reserve the right to acknowledge 
the source of sponsorship in response to any legitimate inquiry. 
 
Neither party will use the name of the other in any form of advertising or publicity without the 
written permission of the other party. 
 
 
 
 
 
 
 

Carpentier-Edwards
® PERIMOUNT
® Magna Ease™, Model 3300TFX 
Clinical Protocol Study 2007-08 Rev. C: March 2008 
 
PROPRIETARY DATA: This document and the information contained herein may not be reproduced, 
used or disclosed without written permission from Edwards Lifesciences LLC. 
 
38 
18. REFERENCES 
 
                                            
1   Yoganathan AP et al. Fluid Mechanics of Heart Valves.  Annual Review of Biomedical 
Engineering 2004; 6:331-362. 
 
2   FDA 1994 draft Replacement Heart Valve Guidance 
 
3   Edmunds, LH, Jr. et al. Guidelines for reporting morbidity and mortality after cardiac 
valvular operations. Ann Thorac Surg, 46:257-259, 1988. 
 
4   Atkins CW, et al. Guidelines for reporting morbidity and mortality after cardiac valvular 
operations. J Thorac Surg, 2008, 135:732-738 
 
5   Bonow, RO, et al. ACC/ AHA Guidelines for the Management of Patients With Valvular 
Heart Disease, Journal of the American College of Cardiology, 48(3), 2006 
 
6   Banbury, MK et al. Age and valve size effect on the long-term durability of the 
Carpentier-Edwards Aortic Pericardial Bioprosthesis, Ann Thorac Surg,  72(3):753-7, 
2001.  
 
7   Frater, RWM, et al. Long-term durability and patient functional status of the Carpentier-
Edwards PERIMOUNT Pericardial Bioprosthesis in the aortic position. The Journal of 
Heart Valve Disease, 7:48-53, 1998 
 
8   Aupart, MR, et al. Perimount Pericardial Bioprosthesis for Aortic Calcified Stenosis: 18-
Year Experience with 1.133 patients, The Journal of Heart Valve Disease, 15:768-76, 
2006 
 
9   Cox, DR. Some simple approximate test for Poisson variates.  Biometrika 40:354-
360,1953  
 
10 Grunkemeier GL, et al., Sample size requirements for evaluating heart valves with 
constant risk events. The Journal of Heart Valve Disease 1994; 3:53-8 
 
11 Sprent P et al., Applied nonparametric statistical methods. Chapman & Hall / CRC. 
New York, New York 2001