A Post Market Observational Study to Obtain Additional Information on the Use of CorMatrix ECM for Pericardial Reconstruction
Conditions: Coronary Disease
Sponsor: Elutia Inc.

 
 
Protocol 14-PR-1095 
 
 
  
  
CONFIDENTIAL 
 
 
 
RECON STUDY 
 
A POST MARKET OBSERVATIONAL STUDY TO OBTAIN ADDITIONAL 
INFORMATION ON THE USE OF CORMATRIX
® ECM® FOR PERICARDIAL 
RECONSTRUCTION  
 
STUDY SPONSOR: 
CORMATRIX CARDIOVASCULAR,
 I
NC. 
1100 OLD ELLIS
 ROAD 
ROSWELL,
 GA 30076 
 
PROTOCOL NUMBER:
 14-PR-1095 
REVISION:
 2.0 
 
 
 
                                                           
July 17, 2014 
 
Please Note:  Confidential information contained herein is made available 
to you in your capacity as Investigator, Medical Advisor, or Consultant 
to CorMatrix Cardiovascular, Inc.  (“CorMatrix”).  It is provided only for 
review by you, your staff, IRB/Ethics Committee members, or other 
regulatory authority.  Except as necessary to provide participant 
with all relevant information, it is expected that there will be no 
disclosure to other persons. 
 
Investigator Statement of Compliance 
I hereby agree to comply with this protocol and applicable regulations 
governing clinical trials, including local regulations, and Good Clinical 
Practice / ICH Guidelines. 
 
 
 
Investigator Signature: ___________________________________________                                           
 
Date: _________________________________________________________ 
 
 
 
 

 
 
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Table of Contents –  
STUDY COORDINATION ...................................................................................................................... 3 
STUDY SYNOPSIS................................................................................................................................ 4 
1. INTRODUCTION AND RATIONALE ............................................................................................... 5 
3. DESCRIPTION 
.................................................................................................................................................. 5 
4. PRIOR CLINICAL EVALUATIONS ................................................................................................... 6 
5. STUDY OBJECTIVES .................................................................................................................... 8 
6. STUDY DESIGN ........................................................................................................................... 8 
7. STUDY POPULATION .................................................................................................................. 8 
8. STUDY METHODS ....................................................................................................................... 8 
9. STUDY PROCEDURES .................................................................................................................. 9 
10. ADVERSE EVENT REPORTING ...................................................................................................... 9 
10.1 DEFINITIONS 
..................................................................................................................................................... 9 
10.2 ASSESSING AND RECORDING ADVERSE EVENTS 
....................................................................................................... 
10 
10.3 POSSIBLE ADVERSE EVENTS 
................................................................................................................................ 
10 
11. DATA ANALYSIS ....................................................................................................................... 
11 
12.  ETHICAL CONSIDERATIONS 
....................................................................................................... 
11 
12.1 CODE OF CONDUCT .......................................................................................................................................... 
11 
12.2 ETHICS COMMITTEE / I
NSTITUTIONAL REVIEW BOARD APPROVAL AND OVERSIGHT......................................................... 
11 
12.3 I
NFORMED CONSENT DOCUMENTATION AND SUBJECT CONFIDENTIALITY....................................................................... 
11 
APPENDIX A .................................................................................... 
ERROR! BOOKMARK NOT DEFINED. 
APPENDIX B ..................................................................................................................................... 
15 
APPENDIX C ..................................................................................................................................... 
16 
APPENDIX D ..................................................................................................................................... 
17 
APPENDIX E ..................................................................................................................................... 
18 
 
 
 
 
 
 

 
 
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CorMatrix Cardiovascular, Inc. 
 
 
 
STUDY COORDINATION 
 
 
 
 
 
STUDY SPONSOR 
CORMATRIX CARDIOVASCULAR, INC. 
1100 OLD ELLIS ROAD 
ROSWELL, GA  30076 
 
 
 
 
DATA COORDINATION 
CENTER 
 
CORMATRIX CARDIOVASCULAR, INC. 
1100 OLD ELLIS ROAD 
ROSWELL, GA  30076 
 

 
 
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Study Synopsis  
 
OBJECTIVE 
The objective of the study is to actively gather additional information on 
the use of CorMatrix ECM for pericardial reconstruction. 
STUDY 
POPULATION 
Up to 100 clinical sites will enroll subjects who have received 
CorMatrix ECM for pericardial reconstruction.   
INDICATIONS FOR 
USE 
The CorMatrix ECM for Pericardial Closure is intended for the 
reconstruction and repair of the pericardium.   
ENDPOINTS 
The endpoint is defined as the proportion of subjects with device related 
adverse events. 
EXAMINATION 
SCHEDULE 
One single post-operative visit following pericardial reconstruction with 
the CorMatrix ECM. 
CLINICAL 
PARAMETERS 
The following clinical data will be collected at a single post-operative 
visit: 
 Demographic information 
 Pre-operative risk factors 
 Surgical procedure 
 Blood transfusion information, if applicable 
 Chest tube placement information 
 Surgical complications 
 Use of anticoagulation medication 
 Cardiac related procedures since surgical procedure 
 Device related adverse events 
 
 

 
 
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1.  Introduction and Rationale 
 
Open heart surgery requires opening the pericardium to gain access to the heart structures.  
Once divided, the pericardium retracts significantly and an inflammatory response starts in 
the body signaling a change has occurred.  Following surgery, the pericardium is difficult to 
re-approximate and is typically left open to avoid causing undue pressure on underlying 
grafts and structures.  However, the absence of the pericardial barrier often leads to scarring 
and the formation of adhesions between the heart and the sternum.  Moreover, the normal 
function of the pericardium is compromised.  Available synthetic materials have largely been 
abandoned for pericardial closure because they have been shown to cause more adhesions, 
calcifications and infections. 
 
The CorMatrix ECM for Pericardial Closure acts as an acellular natural scaffold for repairing 
the pericardium following cardiac surgery.  The acellular ECM scaffold allows the patient’s 
own cells to migrate and attach within the ECM to naturally repair the pericardium. 
 
CorMatrix Cardiovascular, Inc. received FDA 510(k) premarket clearance for the CorMatrix 
ECM for Pericardial Closure (K051405) on August 31, 2005.  This post market observational 
study will evaluate the safety and effectiveness of CorMatrix ECM for pericardial 
reconstruction by collecting specific data at the first post-operative visit.  Data collected from 
this study will not be used to support a marketing claim or change in labeling.  This study is 
being performed to gather post-market data only and is not being performed under the 
direction of the FDA.  This study is of minimal risk and involves no procedures for which 
written consent is usually required.   
 
2. Indication for Use  
 
The CorMatrix ECM for Pericardial Closure is intended for the reconstruction and repair of 
the pericardium.  The entire Instructions for Use (IFU) can be found in Appendix B. 
3. Description  
 
The CorMatrix ECM for Pericardial Closure is an extracellular matrix (ECM) scaffold 
derived from porcine small intestinal submucosa (SIS).  CorMatrix has licensed the 
technology to implement SIS material for use in cardiac surgery.  SIS is a natural collagen 
construct derived from a select layer of tissue that is recovered from porcine small intestine.  
During processing, the inner and outer muscle layers of the intestine are removed, leaving an 
intact, acellular, submucosa with a portion of the tunica propria layer attached to the inner 
surface.  The current CorMatrix ECM application for circumferential pericardial 
reconstruction and repair has demonstrated the same remodeling characteristics in the 
pericardium as other tissues in various animal models.  After several months, cells infiltrate 
into the matrix with a lack of inflammation, lay down a neo-mesothelial lining and 
reconstitute a barrier between the heart and surrounding structures.  The SIS slowly remodels 
and is replaced over time by host tissue.  Based on the properties of the SIS material, SIS is 

 
 
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well suited to replace the area left open in the pericardium following open heart surgery.  The 
CorMatrix ECM for Pericardial Closure is supplied in a lyophilized, sterile state and is for 
single use only.  The CorMatrix ECM can be cut to the appropriate size, using aseptic 
technique, in order to adequately cover the pericardial defect. 
 
4. Prior Clinical Evaluations 
 
CorMatrix ECM has been studied in previous prospective clinical evaluation, and a post-
market clinical study is ongoing.  The ECM for Pericardial closure has been studied in a 
randomized, prospective study to evaluate its ability to reduce the incidence of new onset 
atrial fibrillation; the ECM for Carotid Repair is under evaluation in a post-market study to 
capture and assess device performance data from subjects undergoing patch angioplasty of 
the carotid artery following carotid endarterectomy using the product per its FDA-cleared 
Indications for Use.   
 
4.1.Clinical Evaluation of the ECM Pericardial Closure Device 
 
The CorMatrix ECM Pericardial Closure device was evaluated in a multicenter, 
prospective, randomized, controlled clinical study, to demonstrate the safety and 
effectiveness of the device to reduce the incidence of new onset postoperative atrial 
fibrillation by circumferentially reconstructing the normal pericardial anatomy following 
isolated, first-time, coronary artery bypass grafting (CABG) procedures as compared to 
the control group subjects who did not undergo pericardial closure.  Safety was to be 
established by demonstrating that the composite clinical event rate for the ECM group 
was not worse than the control group.  Effectiveness was to be established by 
demonstrating a reduced incidence of new onset post-operative atrial fibrillation in the 
ECM group as compared to the control group.  440 patients at 15 U.S. sites were enrolled 
between December 2010 and November 2012 and randomized in a 1:1 ratio into either 
the ECM group (pericardial closure) or the control group (no pericardial closure).  A 
blinded, independent core laboratory evaluated all arrhythmia data to determine if 
subjects met the effectiveness endpoints.  A blinded, independent Clinical Events 
Committee adjudicated all safety endpoint events.  Patients were evaluated at hospital 
discharge, 30 days and 270 days postoperatively.  Subjects were adults (at least 18 years 
of age) with no prior history of atrial fibrillation or history of anti-arrhythmia drug 
treatment in the past three months and no implantable cardiac devices (i.e., cardiac 
resynchronization therapy devices with and without defibrillator capabilities [CRT-Ds 
and CRTs), implantable cardioverter-defibrillators [ICDs] and pacemakers) undergoing 
isolated, first-time CABG with a median sternotomy approach. 
 
The primary and secondary effectiveness endpoints, superiority of the ECM over no 
pericardial closure for reduction in the incidence of new onset post-operative atrial 
fibrillation, were not met.  The study results showed that the rate of new onset post-
operative atrial fibrillation for the primary effectiveness endpoint was similar between the 
two groups, with a rate of 38.3% in the ECM group compared with 35.9% in 

 
 
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effectiveness endpoints, the rate of treated or sustained episodes of new onset post-
operative atrial fibrillation (defined as a single episode lasting 15 minutes or more), and 
the rate of treated episodes of new onset post-operative atrial fibrillation, the results were 
also similar between the two groups (36.8% versus 35.0% and 27.4% versus 22.1%, 
respectively, for the ECM group compared with the control group).  
 
The composite primary endpoint event rates for the ECM and control group were 3.9% 
and 3.7%, respectively.  Using the protocol specified non-inferiority margin, 7.5%, the 
ECM was shown to be non-inferior to control for the primary safety endpoint (p<0.001). 
Therefore, the primary safety endpoint for the study was achieved.  The composite 
secondary safety event rate was similar for the two groups (5.8% for the ECM group 
compared with 3.9% for the control group) demonstrating no significant increase in the 
rate of bypass graft failure in the ECM group compared with the control group. 
 
Although the study failed to demonstrate a reduction in the incidence of new onset post-
operative atrial fibrillation, the study demonstrated that the CorMatrix ECM for 
Pericardial Closure continues to be safe for its intended use, with no significant increase 
in the rate of bypass graft failure or cardiac tamponade compared with no pericardial 
closure. 
 
4.2 Post-market Clinical Evaluation of the ECM for Carotid Repair 
 
CorMatrix is currently conducting a post-market registry study for the CorMatrix ECM 
for Carotid Repair (Protocol No. 11-PR-1021).  The objective of this registry is to capture 
and assess device performance data from subjects undergoing patch angioplasty of the 
carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid 
Repair per its commercial Indications for Use.  This registry provides an ongoing post-
market surveillance mechanism to document clinical outcomes on the use of the 
CorMatrix ECM for Carotid Repair.  This is a multi-center, prospective, single-arm, post-
market, observational registry of subjects receiving the CorMatrix ECM for Carotid 
Repair for patch angioplasty following carotid endarterectomy procedures.  This post-
market registry may involve up to ten U.S. clinical sites and up to 230 subjects.  Data will 
be collected through the 24-month follow-up. 
One-hundred and eighty six patients are enrolled in the study and included in the interim 
analysis of the CorMatrix ECM for Carotid Repair registry.  The data demonstrated that 
the rate of device related adverse events were consistent with the rates found in the 
review of the contemporary literature for patch angioplasty.  Specifically, no 
unanticipated events were found and the rate of the events was as anticipated in the risk 
management plan.  Of specific interest in the analysis was the rate of pseudoaneurysm, 
which was present in 2 (1.08%) of the 186 patients and compared favorably to the rates 
found in the literature (1.4% to 5%). 
The mean carotid stenosis (maximum) at pre-operative was 84.8%.  Mean change from 
baseline values were -56.8%, -57.9%, and -59.6% at the 1 to 3-month, 6-month, and 12-
month follow-up evaluations.  The mean carotid stenosis (minimum) at pre-operative was 
71.7%.  Mean change from baseline values were -63.9%, -61.2%, and -63.4% at the 1 to 

 
 
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3-month, 6-month, and 12-month follow-up evaluations.  No data are yet available for the 
24-month follow-up evaluation, as the first enrollment was on May 24, 2012.  
 
As a result of this analysis and the directed and ongoing risk management activities, the 
overall residual risk of the CorMatrix ECM for Carotid Repair is determined to be 
acceptable. 
5. Study Objectives 
 
The objective of the study is to actively gather additional information on the use of 
CorMatrix ECM for pericardial reconstruction. 
 
Endpoint 
The endpoint is defined as the proportion of subjects with device related adverse events.   
 
 
6.  Study Design 
 
This is a multi-center post-market observational study.  It is anticipated that 100 or more 
eligible centers will participate.  There is no upper limit for the number of enrolled subjects.  
Eligible candidates will be approached to ascertain interest in study participation at their 
initial follow up visit.  If a subject has had CorMatrix ECM used in their surgery they will be 
asked to allow their physician to use their medical information from the surgical procedure 
and the current visit.  All elements of the approved informed consent will be provided 
verbally and the process will be documented in the subject study binder by the research staff.  
A copy of the consent will be provided to the participant.  This study includes a one-time 
visit at the initial post-operative visit. 
 
7.  Study Population 
 
The study population will consist of any subject who has received CorMatrix ECM for 
pericardial reconstruction.  Subjects will be considered enrolled into the study once they have 
given permission for their medical information to be collected.  Before any subject can be 
enrolled, the IRB for the specific institution must approve the protocol, the informed consent 
form to be used at that site and a Waiver of Documentation of Consent.  
 
 
8.  Study Methods 
 
Study procedures are standardized to the extent possible and all study-related data will be 
captured on a standardized Case Report Form.  A copy of the Case Report Form is provided 
in Appendix A. 
 
 

 
 
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9.   Study Procedures 
 
Patients returning for a post-operative visit following a surgical procedure with 
pericardial reconstruction with CorMatrix ECM will have the following information 
collected and documented: 
 
 Documentation of the consent process and verbal approval by subject 
 Demographic information 
 Pre-operative risk factors 
 Surgical procedure 
 Blood transfusion information, if applicable 
 Chest tube placement information 
 Surgical complications 
 Use of anticoagulation medication 
 Cardiac related procedures since surgical procedure 
 Device related adverse events 
 
All study-related data will be captured on a standardized Case Report Form.  A copy of 
the Case Report Forms is provided in Appendix A.  Case report forms will be sent to 
CorMatrix via email or mail.  Stamped, self-addressed envelopes will be provided. 
 
Stephanie Beall 
CorMatrix Cardiovascular, Inc. 
1100 Old Ellis Road 
Roswell, GA  30076 
470) 514-4031 Direct Office 
sbeall@cormatrix.com 
10. Adverse Event Reporting 
10.1 Definitions 
 
Adverse Event (AE)  
An adverse event (“AE”) will be defined as any undesirable clinical occurrence in a 
subject whether it is considered to be device related or not, that includes a clinical sign, 
symptom, or condition and/or an observation of an unintended technical performance or 
performance outcome of the device.  Causality is defined as not-related, possibly-related, 
and probably-related to the device.  This post market clinical study will collect only 
events that relate to the use of the CorMatrix ECM as well as any pericardial 
reconstruction clinical findings. 
 
 
Serious Adverse Event (SAE) 
A serious adverse event (“SAE”) will be defined as an event that:  1) threatens life, 2) 
results in permanent impairment of a body function or permanent damage to a body 

 
 
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structure, 3) necessitates medical or surgical intervention to preclude such impairment, 4) 
requires or prolongs hospitalization, or 5) is fatal (death). 
 
Adverse Device Event 
An Adverse Device Event will be defined as a clinical sign, symptom, or condition that is 
causally related to the device procedure, the presence of the device, or the performance of 
the device.  Due to the temporal proximity of the AE to product administration, there is a 
reasonable possibility that the product may have caused the AE or may have contributed 
to the severity or duration of an event caused by other means.   
 
10.2 Assessing and Recording Adverse Events 
 
Each AE recorded must be documented on the Case Report Form.  All serious and device 
related events must be reported immediately to CorMatrix via telephone or email within 
24 hours of the Investigator becoming aware of the event.  The case report form will be 
submitted to CorMatrix.  The site will be contacted by CorMatrix for additional 
information including, but not limited to: 
 
 Description of the event and underlying cause (diagnosis), coexisting disease, or 
other. 
 Date of onset and date of resolution.  If the event is present at the single post-
operative visit it will be marked as unresolved.  
 Intensity of the event:  mild, moderate, or severe. 
 Frequency of the event:  single episode, intermittent, or continuous. 
 Action taken:  none, medication, procedure, medication and procedure, or other.   
 Relationship to the procedure/surgery:  not-related, possibly-related, or probably-
related.  
 
The Investigator must ensure that the details of the event are documented in the medical 
notes including full details of the outcome, in addition to recording the event on the 
appropriate case report form.   
 
Serious adverse events and/or device related events contact information at CorMatrix: 
 
Dawn Flanders 
Quality Systems Manager, CorMatrix 
(470) 514-4029 
RECON@cormatrix.com 
 
10.3 Possible Adverse Events 
 
Potential risks are the same as those associated with any thoracic surgery procedure, 
including bleeding, MI, stroke, death, and scarring from the incision.  There is also a risk 
of infection and/or wound healing complications, but an increase in these 

 
 
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complications over standard thoracic surgery has not been observed in other pericardial 
closure/reconstruction.  This study will capture events reported at the first (initial) 
postoperative follow up as reported by the PI and/or subject and from a review of medical 
records.    
11. Data Analysis   
Since this is a post-market study, analyses will consist of tabulated data and descriptive 
statistics.  Subject data listings and tabular and graphical presentations of the summary 
and statistical results will be provided.  Additional quantitative and qualitative 
comparisons will be made to contemporary literature and similar studies  
12.  Ethical Considerations 
12.1 Code of Conduct 
 
The Investigator will ensure that the clinical study is conducted in accordance with good 
clinical practice and all regulatory and institutional requirements, including those for 
subject privacy, informed consent, Institutional Review Board or Ethics Committee 
approval, and record retention.  (Appendix D:  Investigator Qualifications and 
Responsibilities) 
12.2 Ethics Committee / Institutional Review Board Approval and Oversight 
 
The Investigator must obtain appropriate Ethics Committee (“EC”) or Institutional 
Review Board (“IRB”) approval before the study can be initiated.  A copy of the written 
approval from the EC/IRB and a copy of the approved Informed Consent Form (approved 
Waiver of Documentation of Consent, if applicable) should be sent to CorMatrix.  
Appropriate study progress reports will be prepared for the EC/IRB by the Principal 
Investigator. Any changes to the protocol must be discussed and approved by CorMatrix 
in writing unless the change is made to assure the safety of the subject.  In the non-
emergent setting, after agreement on the changes has been reached, an amendment to the 
protocol will be provided by CorMatrix for submission to the EC/IRB for review and 
approval prior to initiation of the change.  Any change made emergently must be 
documented in the subject
's medical record.  The Investigator must immediately forward 
to the EC/IRB any written safety reports or updates from CorMatrix.   
12.3 Informed Consent Documentation and Subject Confidentiality 
 
The investigator will be responsible for submitting the clinical study protocol and 
Informed Consent/Waiver of Documentation of Consent to their EC/IRB or centralized 
EC/IRB.  The Informed Consent/Waiver of Documentation of Consent and protocol must 
be approved by the local/centralized EC/IRB before the study is initiated and subjects 
enrolled.  Prior to obtaining any study specific information approved informed consent 
will be reviewed with the subject and the subject must provide verbal approval.  
Documentation of the consent process must be completed by the research personnel.  The 

 
 
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investigator shall provide a copy of the Informed Consent to the subject.  Completed 
documentation of the consent process will be available for auditing by CorMatrix or their 
representative, as applicable.   
 
CorMatrix will maintain the confidentiality of the identity of subjects enrolled in the 
study and the information contained in their study records.  CorMatrix will also instruct 
the study investigators in the importance of maintaining the confidentiality of study 
records.  Any publication of any data collected as part of this trial will only use de-
identified data, so that identification of any individual subject will not be possible.  The 
records will be made available as required for review by the FDA, or other applicable 
regulatory agency and a reviewing EC/IRB; however to the extent possible, the subject’s 
identity will not be disclosed.  The Case Report Forms will use a subject identification 
number, with the patient name and address NOT appearing anywhere on the study form 
to be submitted to the sponsor (Appendix C:  Sponsor’s Commitments). 
 
 
 
 
 
 

 
 
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13. Bibliography  
 
Wyler von Ballmoos M, Murtaza G, Gasparri M, Masroor S. Reconstruction of the right atrium 
using an extracellular matrix patch in a patient with severe mediastinal aspergillosis.  Int J Surg 
Case Rep. 2013; 4(3): 290-292. 
 
Stelly M, Stelly TC. Histology of CorMatrix Bioscaffold 5 Years After Pericardial Closure. Ann 
Thorac Surg.2013; 96(5):e127-e129. 
 
Weber SS, Annenberg AJ, Wright CB, Braverman TS, Mesh CL. Early pseudoaneurysm 
degeneration in biologic extracellular matrix patch for carotid repair. J Vasc Surg. 2013; Epub 
ahead of print 
 
Slachman FN. Constructive Remodeling of CorMatrix ECM Following Aortic Root Repair in a 
90 Year-old Female.Ann Thorac Surg. 2013; In Press. 
 
Dearani JA, Said SM, O
'Leary PW, Burkhart HM, Barnes RD, Cetta F. Anatomic repair of 
Ebstein
's malformation: lessons learned with cone reconstruction. Ann Thorac Surg. 2013; 
95(1):220-6; discussion 226. 
 
Poulin F, Horlick EM, David T, Woo A, Thavendiranathan P. 3-Dimensional transesophageal 
echocardiography-guided closure of a Gerbode shunt due to CorMatrix patch dehiscence. J Am 
Coll Cardiol. 2013; 62(3):e5. 
 
Quarti A, Nardone S, Colaneri M, Santoro G, Pozzi M. Valve leaflet reconstruction in pediatrics 
with extracellular matrix patch. J Heart Valve Dis. 2012; 21(1):138-139. 
 
Sundermann SH, Biefer HR, Emmert MY, Falk V. Use of Extracellular Matrix Materials in 
Patients with Endocarditis.Thorac Cardiovasc Surg. 2012;Epub ahead of print. DOI: 10.1055/s-
0032-1328920 
 
Smith CR, Stamou SC, Boeve TJ, Hooker RC. Repair of a penetrating ascending aortic ulcer 
with localized resection and extracellular matrix patch aortoplasty. Ann Thorac Surg. 2012; 
94(3):988-989. 
 
Chalajour F, Barboza LA, Boni L et al. Reconstruction of pulmonary artery in a newborn using a 
porcine small intestinal submucosal patch. Ann Thorac Surg. 2012; 93(4):1311-1315. 
 
Mavroudis CD, Casillan A, Rabbat M et al. Primary Intimal Sarcoma of the Pulmonary Vein 
with Extension into the Left Atrium: A Case Report. Open Journal of Thoracic Surgery. 2012; 
2(2):25-28. 
 
Tweddell JS, Mitchell ME, Woods RK, Spray TL, Quintessenza JA. Construction of the Right 
Ventricle-to-Pulmonary Artery Conduit in the Norwood: The "Dunk" Technique. Operative 
Techniques in Thoracic and Cardiovascular Surgery. 2012; 17(2):81-98. 

 
 
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Boyd WD, Tyberg JV, Cox JL. A review of the current status of pericardial closure following 
cardiac surgery. Expert Rev Cardiovasc Ther. 2012; 10(9):1109-1118. 
 
Quarti A, Nardone S, Colaneri M, Santoro G, Pozzi M. Preliminary experience in the use of an 
extracellular matrix to repair congenital heart diseases. Interact Cardiovasc Thorac Surg. 2011; 
13(6):569-572. 
 
Gerdisch MW, Akinwande AO, Matheny RG. Use of a novel acellular xenograft as a patch for 
aortic annular enlargement during aortic valve replacement. Innovations. 2010; 5(1):60-62. 
 
Scholl FG, Boucek MM, Chan KC, Valdes-Cruz L, Perryman R. Preliminary experience with 
cardiac reconstruction using decellularized porcine extracellular matrix scaffold: human 
applications in congenital heart disease. World Journal for Pediatric and Congenital Heart 
Surgery. 2010; 1(1):132-136. 
 
Boyd WD, Johnson WE, Sultan PK, Deering TF, Matheny RG. Pericardial reconstruction using 
an extracellular matrix implant correlates with reduced risk of postoperative atrial fibrillation in 
coronary artery bypass surgery patients. Heart Surg Forum. 2010; 13(5):E311-E316. 
 
Piterina AV, Cloonan AJ, Meaney CL et al. ECM-based materials in cardiovascular applications: 
Inherent healing potential and augmentation of native regenerative processes. Int J Mol 
Sci. 2009; 10(10):4375-4417. 
 
 

 
 
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Appendix A 
Case Report Form 
 
 
To be provided as a separate document 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Appendix B 
Instructions for Use 
 
 
To be provided as a separate document 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Appendix C 
Sponsor Commitments 
 
 
 
 
SPONSOR’
S COMMITMENTS 
CorMatrix is committed to: 
1. Complying with the Declaration of Helsinki and all applicable health authority 
regulations governing the conduct of clinical research studies. 
2. Protecting the rights, health, safety and welfare of study subjects. 
3. Informing the clinical investigators of any new information about the study which may 
affect the health, safety, or welfare of the subjects, or may influence their decision to 
continue participation in the study. 
4. Providing the clinical investigators with the study protocol and Case Report Form on 
which to document the study evaluation variables for each subject entered into the study. 
5. Providing the clinical investigators and study staff training on the protocol and 
completion of the Case Report Form. 
6. Providing the statistical analysis and study report writing resources necessary to complete 
reporting of the study results. 
7. Certifying that EC/IRB approval of the protocol and Investigators Agreement will be 
completed prior to treatment at a clinical site. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Appendix D 
Investigator Qualifications and Responsibilities 
 
INVESTIGATOR QUALIFICATIONS AND RESPONSIBILITIES 
 
Each investigator must be a licensed physician who has received training for using the CorMatrix 
ECM for the reconstruction and repair of the pericardium.  The investigators have the following 
responsibilities: 
 
1. Subject Selection 
The investigator is responsible for assuring that all subjects entering the study are eligible to 
participate. 
 
2. Informed Consent 
The investigator is responsible for fully reviewing the nature of the study.  The investigator is 
responsible for documenting the Informed Consent process in compliance with applicable 
regulations for each patient, prior to enrollment in the trial.  A copy of the Informed Consent 
Form and documentation of the consent process will be maintained in the patient
's medical 
record. 
 
3. Ethics Committee (EC)/Institutional Review Board (IRB) Approval 
The investigator must obtain approval for his participation in this protocol from an EC/IRB 
prior to entering any patients in the study.  The Informed Consent document and Waiver of 
Documentation of Consent to be used will also be submitted by the Investigator to the 
EC/IRB for approval prior to initiation of the study.  Assurance that the EC/IRB approval of 
the study protocol and Informed Consent/Waiver of Documentation of Consent has been 
obtained will be provided to the Sponsor prior to initiation of the study. 
 
4. Subject Evaluation and Data Reporting 
The investigator is responsible for performing the patient evaluations as described in the 
study protocol.  All information generated by the patient evaluation will be recorded on the 
Subject Case Report Form provided by the Sponsor.  The Case Report Form will be filled out 
in black ink.  Any corrections will be made by lining out with a single line, providing the 
date of corrections and initials of person making the correction.  Correction fluid will not be 
used.  The person completing the form will date and initial each form upon its completion 
and will send the form via mail, email or fax to CorMatrix.  Copies of all Case Report Forms 
will be retained in the Investigator
's office.  
 
5. Record Retention 
The Investigator must retain all subject records for at least 2 years, or longer, if required by 
local regulations.