Retrospective Experience of CIED Implantation With Piedmont Athens Regional Electrophysiology
Conditions: Cardiac Disease, Heart Failure, Coronary Artery Disease
Sponsor: Elutia Inc.

 
 
 
TYPE:    Protocol 
Document CPR-2212 
TITLE:  RETROSPECTIVE EXPERIENCE OF CIED 
IMPLANTATION WITH PIEDMONT ATHENS 
REGIONAL ELECTROPHYSIOLOGY 
Revision  C 
Page   1   of   9 
 
 
 
CONFIDENTIAL 
DCR-01058 
 
 
Release Date: 12/02/20 
 
 
 
 
 RETROSPECTIVE EXPERIENCE OF CIED IMPLANTATION WITH 
PIEDMONT ATHENS REGIONAL ELECTROPHYSIOLOGY 
 
 
 
 
STUDY SPONSOR: 
AZIYO BIOLOGICS, INC. 
1100 OLD ELLIS ROAD, SUITE 1200 
ROSWELL, GA  30076 
 
PROTOCOL NUMBER: 
CPR-2212C 
 
NCT #04351269 
 
 
Protocol Date: 
December 2, 2020 
 
 
Please Note: Confidential information contained herein is made available to 
you in your capacity as Investigator, Medical Advisor, or Consultant to 
Aziyo Biologics. It is provided only for review by you, your staff, 
IRB/Ethics Committee members, or other regulatory authority. Except as 
necessary to obtain properly informed consent for participation, 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: _________________________________________________________ 
 
 

 
 
 
TYPE:    Protocol 
Document CPR-2212 
TITLE:  RETROSPECTIVE EXPERIENCE OF CIED 
IMPLANTATION WITH PIEDMONT ATHENS 
REGIONAL ELECTROPHYSIOLOGY 
Revision  C 
Page   2   of   9 
 
 
 
CONFIDENTIAL 
DCR-01058 
 
 
Release Date: 12/02/20 
Summary of Changes from Previous Version 
Affected Section(s) 
Summary of Revisions Made 
Rationale 
Study Synopsis, 
Design 
Changed enrollment limit to 700 subjects 
from 600. 
The enrollment limit was increased to allow the 
site the ability to enroll all available subjects. 
Section 2, Study 
Design & Methods 
Changed enrollment limit to 700 subjects 
from 600. 
The enrollment limit was increased to allow the 
site the ability to enroll all available subjects. 
 
 
 
Table of Contents –  
STUDY COORDINATION........................................................................................................................ 3 
STUDY SYNOPSIS .................................................................................................................................... 4 
1. 
INTRODUCTION AND RATIONALE ........................................................................................... 5 
2. 
STUDY DESIGN AND METHODS ................................................................................................. 5 
3. 
STUDY OBJECTIVES ...................................................................................................................... 7 
4. 
RISKS AND BENEFITS ................................................................................................................... 7 
4.1.  RISKS ........................................................................................................................................................ 7 
4.2.  BENEFITS .................................................................................................................................................. 7 
5. 
DATA ANALYSIS ............................................................................................................................. 7 
6. 
ETHICAL CONSIDERATIONS ...................................................................................................... 8 
6.1.  CODE OF CONDUCT ................................................................................................................................... 8 
6.2.  INSTITUTIONAL REVIEW BOARD APPROVAL AND OVERSIGHT .................................................................... 8 
7. 
BIBLIOGRAPHY .............................................................................................................................. 9 
 
 
 
 
 
 
 

 
 
 
TYPE:    Protocol 
Document CPR-2212 
TITLE:  RETROSPECTIVE EXPERIENCE OF CIED 
IMPLANTATION WITH PIEDMONT ATHENS 
REGIONAL ELECTROPHYSIOLOGY 
Revision  C 
Page   3   of   9 
 
 
 
CONFIDENTIAL 
DCR-01058 
 
 
Release Date: 12/02/20 
 
 
 
STUDY COORDINATION 
 
 
 
 
 
STUDY SPONSOR 
AZIYO BIOLOGICS, INC. 
1100 OLD ELLIS ROAD, SUITE 1200 
ROSWELL, GA  30076 
 
 
 
 
DATA COORDINATION 
CENTER 
 
AZIYO BIOLOGICS, INC. 
1100 OLD ELLIS ROAD, SUITE 1200 
ROSWELL, GA  30076 
 

 
 
 
TYPE:    Protocol 
Document CPR-2212 
TITLE:  RETROSPECTIVE EXPERIENCE OF CIED 
IMPLANTATION WITH PIEDMONT ATHENS 
REGIONAL ELECTROPHYSIOLOGY 
Revision  C 
Page   4   of   9 
 
 
 
CONFIDENTIAL 
DCR-01058 
 
 
Release Date: 12/02/20 
 
Study Synopsis  
 
COMPANY 
Aziyo Biologics, Inc. 
PROTOCOL NO. 
CPR-2212 
PRODUCT(S) 
CanGaroo® Envelope and Tyrx™ Absorbable Antibacterial Envelope 
PROTOCOL 
TITLE: 
Retrospective Experience of CIED Implantation with Piedmont Athens 
Regional Electrophysiology 
OBJECTIVE 
The objective of this study is to retrospectively gather information on 
patients who underwent a CIED procedure with either a CanGaroo, 
Tyrx envelope, or no envelope.   
DESIGN 
A single center will retrospectively review up to 700 subjects who 
underwent implantation of a CIED with CanGaroo, Tyrx, or no 
envelope.  All sets of subjects enrolled will also be examined for any 
follow-up visits and/or adverse events that occurred up to 12 months 
post-surgery. 
STUDY 
POPULATION 
Male or female patients who underwent a CIED implantation utilizing 
CanGaroo hydrated in saline, CanGaroo hydrated in Antibiotic, Tyrx, or 
no envelope. 
ENDPOINTS 
The endpoints will be defined as: 
1. The incidence of major infection post procedure. 
2. Any pocket related issues that prompted an office visit 
CLINICAL 
PARAMETERS 
The following clinical data will be collected  
 Demographic information 
 Risk factors for infection 
 Surgical procedure 
 Type of device implanted 
 Envelope soak solution used 
 Post procedure information on major infections as defined 
below 
 Post procedure information on pocket related issues 
 Post procedure information on hematoma 
DURATION 
Data will be collected for a minimum of one post-surgical visit after CIED 
implant for all groups.  If more visits are available, data from those visits 
will be collected up to 12 months post-procedure. 
CENTERS 
Single center in the U.S. 

 
 
 
TYPE:    Protocol 
Document CPR-2212 
TITLE:  RETROSPECTIVE EXPERIENCE OF CIED 
IMPLANTATION WITH PIEDMONT ATHENS 
REGIONAL ELECTROPHYSIOLOGY 
Revision  C 
Page   5   of   9 
 
 
 
CONFIDENTIAL 
DCR-01058 
 
 
Release Date: 12/02/20 
1.  Introduction and Rationale 
 
This document is a protocol for a human research study. This study is to be conducted 
according to U.S. and international standards of Good Clinical Practice in accordance with 
applicable Federal regulations, International Conference on Harmonization guidelines, and 
institutional research policies and procedures. 
 
Broader indications for the implant of cardiac implantable electronic devices (CIED) and 
population aging are the main reasons for the continuous increase in the use of pacemakers, 
implantable cardioverter-defibrillators, and devices for cardiac resynchronization therapy.  
The rate of infection is out of proportion to the increase in implantation rate. This is primarily 
due to the comorbidities in CIED patients, the greater complexity of the devices, and the 
increased duration of procedures.1,2,3   
 
2. Study Design and Methods 
 
Clinical records will be reviewed and data collected for up to 700 subjects who underwent 
implantation of a CIED.   All sets of subjects will have data reviewed for any visits on or 
after March 27, 2017. No subject will be excluded from the study based on gender, racial, or 
ethnic origin. Patients will not be contacted and only de-identified data will be collected. A 
waiver of Informed Consent and HIPAA authorization will be requested from the IRB.   
 
Each patient’s medical records will be reviewed by the investigator or designated personnel 
for basic clinical data, including demographic information, risk factors for infection, 
information about the surgical procedure, type of device implanted, and post procedure 
information on infection, pocket related issues, and hematoma information will all be 
collected for each subject. Data will be collected retrospectively using Electronic Data 
Capture (Medrio). 
 
CIED infections are defined as (1) superficial cellulitis in the region of the CIED pocket with 
wound dehiscence, erosion, or purulent drainage, (2) deep incisional or organ/space 
(generator pocket) surgical site infection that meets the Centers for Disease Control and 
Prevention criteria, independent from time of surgery, (3) persistent bacteremia, or (4) 
endocarditis. 
Major CIED infections are defined as a CIED infection resulting in one or more of the 
following: 
 
CIED system removal 
 
Any invasive procedure (e.g., pocket opened) without system removal 

 
 
 
TYPE:    Protocol 
Document CPR-2212 
TITLE:  RETROSPECTIVE EXPERIENCE OF CIED 
IMPLANTATION WITH PIEDMONT ATHENS 
REGIONAL ELECTROPHYSIOLOGY 
Revision  C 
Page   6   of   9 
 
 
 
CONFIDENTIAL 
DCR-01058 
 
 
Release Date: 12/02/20 
 
Treatment with antibiotic therapy if the subject is not a candidate for system removal 
and infection recurrence after completion of antibiotic therapy or evidence of deep 
infection with wound dehiscence, erosion, or purulent drainage 
 
Death 
 
Any serious adverse event that requires a Medical Device Report will be reported by the 
Sponsor to the FDA in accordance with Sponsor’s Medical Device Reporting SOP. The site 
should contact: 
 
Stephanie Richardson 
678-492-4712 
srichardson@aziyo.com 
 
A code will be used to protect patient confidentiality. The key to the code will be kept 
separate from the data.   
 
2.1 Schedule of Assessments 
 
 
Pre-Procedure 
Screening Visit
Procedure 
Visit 
Follow-up Visits 
(up to 
12 mo.) 
Unscheduled 
Visit 
Inclusion Determination 
X 
 
 
 
Baseline Demographics  
X 
 
 
 
Medical History/Risk Factors 
X 
 
 
 
Type of Device Implanted 
 
X 
 
 
Envelope Soak Solution Used 
 
X 
 
 
Procedure Details 
 
X 
 
 
Documentation of Complications 
 
X 
 
 
Post-Operative Events  
 
 
X 
X 
Infection Information/Culture 
Results 
 
 
X 
X 
 Pocket Related Issues 
 
 
X 
X 

 
 
 
TYPE:    Protocol 
Document CPR-2212 
TITLE:  RETROSPECTIVE EXPERIENCE OF CIED 
IMPLANTATION WITH PIEDMONT ATHENS 
REGIONAL ELECTROPHYSIOLOGY 
Revision  C 
Page   7   of   9 
 
 
 
CONFIDENTIAL 
DCR-01058 
 
 
Release Date: 12/02/20 
 
3. Study Objectives 
 
The objective of the study is to: 
1. The objective of this study is to retrospectively gather information on patients who 
underwent a CIED procedure with either a CanGaroo, Tyrx envelope, or no envelope.   
Endpoints 
The endpoints are defined as: 
1. The incidence of major post procedure infection (as defined above)  
2. Any pocket related issues that prompted an office visit which include but are not limited 
to pain, swelling, redness, migration and/or hematoma 
4. Risks and Benefits 
4.1.Risks 
As this is a retrospective study, there are no physical potential risks to research subjects.   
There may be risks associated with loss of privacy. 
4.2. Benefits 
As this is a retrospective study, there are no physical benefit to individual research subjects; 
however, society and physicians will benefit from the knowledge gained. 
 
5. Data Analysis   
Since this is a retrospective 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 between the groups of subjects, contemporary literature, and similar studies.  
Statistical comparisons between treatment groups (CanGaroo versus Tyrx versus no 
envelope) will be performed using Fisher’s exact test or Chi-square tests for categorical 
variables.  Continuous variables will be analyzed using ANOVA.  A log rank test will be 
performed to compare the time to infection between the CanGaroo, Tyrx, and no envelope 
treatment groups at all of the follow-up visits.  
 
 
 
 
 
 
 
 
 

 
 
 
TYPE:    Protocol 
Document CPR-2212 
TITLE:  RETROSPECTIVE EXPERIENCE OF CIED 
IMPLANTATION WITH PIEDMONT ATHENS 
REGIONAL ELECTROPHYSIOLOGY 
Revision  C 
Page   8   of   9 
 
 
 
CONFIDENTIAL 
DCR-01058 
 
 
Release Date: 12/02/20 
 
6. Ethical Considerations 
6.1.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.   
 
6.2.Institutional Review Board Approval and Oversight 
 
This protocol, or any subsequent modifications, will be reviewed and approved by an 
Institutional Review Board. A Waiver of Informed Consent and HIPAA due to the 
retrospective nature of this study will be requested. 
 
The confidentiality of the identity of subjects enrolled in the study and the information 
contained in their study records will be maintained. 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 IRB; however to the extent possible, the subject’s 
identity will not be disclosed.   
 
A subject identification number will be used during data collection and the patient name, 
date of birth, medical record number and/or address will NOT appear anywhere. 
 
 
 
 
 
 

 
 
 
TYPE:    Protocol 
Document CPR-2212 
TITLE:  RETROSPECTIVE EXPERIENCE OF CIED 
IMPLANTATION WITH PIEDMONT ATHENS 
REGIONAL ELECTROPHYSIOLOGY 
Revision  C 
Page   9   of   9 
 
 
 
CONFIDENTIAL 
DCR-01058 
 
 
Release Date: 12/02/20 
 
7. Bibliography  
 
1. Mond HG, Proclemer A. The 11th world survey of cardiac pacing and implantable  
cardioverter-defibrillators: calendar year 2009 – a World Society of Arrhythmia’s project, 
Pacing Clin Electrophysiol 2011; 34:1013–27.  DOI: 10.1111/j.1540 8159.2011.03150.x; 
PMID: 21707667. 
 
2. Beck H, Boden WE, Patibandla S, et al. 50th anniversary of the first successful 
permanent pacemaker implantation in the United States: historical review and future 
directions. Am J Cardiol 2010; 106:810–8. PMID: 21391322. 
 
3. Khaldoun G Tarakji, Christopher R Ellis, Pascal Defaye and Charles Kennergren Cardiac 
Implantable Electronic Device Infection in Patients at Risk, ARRHYTHMIA & 
ELECTROPHYSIOLOGY REVIEW 2016.