Bridge Occlusion Balloon Initial Use in Humans Study
Phase: NA
Conditions: C.Surgical Procedure; Cardiac, Cardiac Dysrhythmia, Disorder of Pacing Function
Sponsor: Yale University

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NCT02714153 
Bridge Occlusion Balloon in Lead Extraction Procedure 
8/8/2016 
 

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YALE UNIVERSITY 
HUMAN INVESTIGATION COMMITTEE 
Application to Involve Human Subjects in Biomedical Research 
100 FR1 (2015-2) 
 
 
 
 
 
 
 
Title of Research Project: Bridge Occlusion Balloon in Lead Extraction Procedure 
Principal Investigator: 
Jude Clancy, MD 
Yale Academic Appointment: 
Assistant Professor of Medicine 
Department: Internal Medicine, Section of Cardiology 
Campus Address: 330 Cedar Street, Dana 3 New Haven, CT 06520 
Campus Phone: 785-4126 
Fax: 785-6506 
Pager: 
E-mail: jude.clancy@yale.edu 
Protocol Correspondent Name & Address (if different than PI): 
Bemen Habashi  
789 Howard Ave, DANA 345 New Haven CT 06520 
Campus Phone: 737-1330 
Fax: 785-6457 
E-mail: bemen,habashi@yale.edu 
Yale Cancer Center CTO Protocol Correspondent Name & Address (if applicable): 
Campus Phone: 
Fax: 
E-mail: 
Business Manager: 
Campus Phone : 
Fax : 
E-mail 
 
ntment: 
 
 
 
 
 
 
 
 
 
Investigator Interests: 
Does the principal investigator, or do any research personnel who are responsible for the design, 
conduct or reporting of this project or any of their family members (spouse or dependent child) 
have an incentive or interest, financial or otherwise, that may affect the protection of the human 
subjects involved in this project, the scientific objectivity of the research or its integrity? Note: 
The Principal Investigator (Project Director), upon consideration of the individual’s role and 
degree of independence in carrying out the work, will determine who is responsible for the 
design, conduct, or reporting of the research. 
See Disclosures and Management of Personal Interests in Human Research  
http://www.yale.edu/hrpp/policies/index.html#COI 
■ Yes 
⧠  No 
SECTION I: ADMINISTRATIVE INFORMATION 
Faculty Advisor:(required if PI is a student, 
resident, fellow or other trainee)
 
N
Campus Address: 
Campus Phone: 
Fax: 
Pager: 
E-mail: 

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Do you or does anyone on the research team who is determined by you to be responsible for the 
design, conduct or reporting of this research have any patent (sole right to make, use or sell an 
invention) or copyright (exclusive rights to an original work) interests related to this research 
protocol? 
 Yes 
No 
 
If yes to either question above, list names of the investigator or responsible person: 
Jude Clancy, relationships with industry have been disclosed to COI office 
The Yale University Principal Investigator, all Yale University co-investigators, and all Yale 
University individuals who are responsible for the design, conduct or reporting of research must 
have a current financial disclosure form on file with the University’s Conflict of Interest Office. 
Yale New Haven Hospital personnel who are listed as co-investigators on a protocol with a Yale 
University Principal Investigator must also have a current financial disclosure form on file with 
the University’s Conflict of Interest Office. If this has not been done, the individual(s) should 
follow this link to the COI Office Website to complete the form:  http://www.yale.edu/coi/ 
 
NOTE: The requirement for maintaining a current disclosure form on file with the University’s 
Conflict of Interest Office extends primarily to Yale University and Yale-New Haven Hospital 
personnel. Whether or not they are required to maintain a disclosure form with the 
University’s Conflict of Interest Office, all investigators and individuals deemed otherwise 
responsible by the PI who are listed on the protocol are required to disclose to the PI any 
interests that are specific to this protocol. 
 
 
 
1. Performing Organizations: Identify the hospital, in-patient or outpatient facility, school or 
other agency that will serve as the location of the research. Choose all that apply: 
 
a. Internal Location[s] of the Study: 
Magnetic Resonance Research Center 
Yale University PET Center 
(MR-TAC) 
YCCI/Church Street Research Unit (CSRU) 
Yale Cancer Center/Clinical Trials Office (CTO) 
YCCI/Hospital Research Unit (HRU) 
Yale Cancer Center/Smilow 
YCCI/Keck Laboratories 
Yale-New Haven Hospital 
Yale-New Haven Hospital—Saint Raphael Campus 
Cancer Data Repository/Tumor Registry 
Specify Other Yale Location: 
 
 
b. External Location[s]: 
APT Foundation, Inc. 
Haskins Laboratories 
Connecticut Mental Health Center 
John B. Pierce Laboratory, Inc. 
Clinical Neuroscience Research Unit (CNRU) 
Veterans Affairs Hospital, West Haven 
Other Locations, Specify: 
International Research Site 
(Specify location(s)): 
SECTION II: GENERAL INFORMATION 

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c. Additional Required Documents (check all that apply): 
N/A 
*YCCI-Scientific and Safety Committee (YCCI-SSC) 
Approval Date: 
*Pediatric Protocol Review Committee (PPRC) 
Approval Date: 
*YCC Protocol Review Committee (YRC-PRC) 
Approval Date: 
*Dept. of Veterans Affairs, West Haven VA HSS 
Approval Date: 
*Radioactive Drug Research Committee (RDRC) 
Approval Date: 
YNHH-Radiation Safety Committee (YNHH-RSC) 
Approval Date: Pending 
Yale University RSC (YU-RSC) 
Approval Date: 
Magnetic Resonance Research Center PRC (MRRC-PRC) 
Approval Date: 
*Nursing Research Committee 
Approval Date: 
YSM/YNHH Cancer Data Repository (CaDR) 
Approval Date: 
Dept. of Lab Medicine request for services or specimens form 
Imaging on YNHH Diagnostic Radiology equipment request form (YDRCTO request) found 
at http://radiology.yale.edu/research/ClinTrials.aspx) 
*Approval from these committees is required before final HIC approval is granted. See instructions 
for documents required for initial submission and approval of the protocol. Allow sufficient time for 
these requests. Check with the oversight body for their time requirements. 
 
2. Probable Duration of Project: State the expected duration of the project, including all 
follow-up and data analysis activities. 
1 Year. 
 
3. Research Type/Phase: (Check all that apply) 
a. Study Type 
Single Center Study 
Multi-Center Study 
Does the Yale PI serve as the PI of the multi-site study? Yes 
No 
Coordinating Center/Data Management 
Other: 
 
 List of the other sites: 
 
Dr. Bruce L. Wilkoff 
Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 
Dr. Laurence M. Epstein 
Brigham and Women’s Hospital, 75 Francis St, Boston, MA 
Dr. Roger G. Carrillo 
University of Miami Health System, 1295 NW 14th St, Miami, FL 
Dr. Jonathan Piccini Sr. 
Duke University Hospital, 2301 Erwin rd, Durham, NC 
Dr. John A. Andriulli 
Cooper University Hospital, 1 Cooper Plaza, Camden, NJ 
Dr. Pierce Vatterott 
United Hospital, 333 N Smith Ave, St. Paul, MN 
Dr. Rohit Mehta 
Carolinas HealthCare System, Charlotte, North Carolina, United States, 28203 

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b. Study Phase 
N/A 
Pilot 
Phase I 
Phase II 
Phase III 
Phase IV 
Other (Specify): Investigator initiated, post market study. 
 
 
4. Area of Research: (Check all that apply) Note that these are overlapping definitions and 
more than one category may apply to your research protocol. Definitions for the following 
can be found in the instructions section 4c: 
Clinical Research: Patient-Oriented 
Clinical Research: Outcomes and 
Clinical Research: Epidemiologic and Behavioral 
 
Health Services 
Translational Research #1 (“Bench-to-Bedside”) 
Interdisciplinary Research 
Translational Research #2 (“Bedside-to-Community”) 
Community-Based Research 
 
 
5. Is this study a clinical trial? Yes 
No 
NOTE the current ICMJE (International Committee of Medical Journal Editors) definition of a 
clinical trial: “any research study that prospectively assigns human participants or groups of humans 
to one or more health-related interventions to evaluate the effects on health outcomes.” Health-related 
interventions include any intervention used to modify a biomedical or health-related outcome (for 
example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and 
process-of-care changes). Health outcomes include any biomedical or health-related measures 
obtained in patients or participants, including pharmacokinetic measures and adverse events” 
If yes, where is it registered? 
Clinical Trials.gov registry 
Other (Specify) 
 
Registration of clinical trials at their initiation is required by the FDA, NIH and by the ICMJE. 
 
If this study is registered on clinicaltrials.gov, there is new language in the consent form and compound 
authorization that should be used. 
 
For more information on registering clinical trials, including whether your trial must be 
registered, see the YCCI webpage, http://ycci.yale.edu/researchers/ors/registerstudy.aspx 
or contact YCCI at 203.785.3482) 
 
 
6. Does the Clinical Trials Agreement (CTA) require compliance with ICH GCP (E6)? 
Yes 
No 
 
 
7. Will this study have a billable service? A billable service is defined as any service rendered to 
a study subject that, if he/she was not on a study, would normally generate a bill from either 
Yale-New Haven Hospital or Yale Medical Group to the patient or the patient’s insurer. The 
service may or may not be performed by the research staff on your study, but may be provided by 
professionals within either Yale-New Haven Hospital or Yale Medical Group (examples include 

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x-rays, MRIs, CT scans, specimens sent to central labs, or specimens sent to pathology). Notes: 
1. There is no distinction made whether the service is paid for by the subject or their insurance 
(Standard of Care) or by the study’s funding mechanism (Research Sponsored). 2. This generally 
includes new services or orders placed in EPIC for research subjects. 
 
Yes 
No 
If answered, “yes”, this study will need to be set up in OnCore, Yale’s clinical research 
management system, for Epic to appropriately route research related charges. Please contact  
oncore.support@yale.edu 
8.. Are there any procedures involved in this protocol that will be performed at YNHH or one of 
its affiliated entities? Yes    X_ No   
 If Yes, please answer questions a through c and note 
instructions below.  If No, proceed to Section III. 
a. Does your YNHH privilege delineation currently include the specific procedure that you will 
perform?   Yes 
b. Will you be using any new equipment or equipment that you have not used in the past for 
this procedure?   Yes 
 
c. Will a novel approach using existing equipment be applied?  Yes 
 
If you answered “no” to question 8a, or "yes" to question 8b or c, please contact the YNHH 
Department of Physician Services (688-2615) for prior approval before commencing with your 
research protocol. 
 
Please note that if this protocol includes Yale-New Haven Hospital patients, including patients at 
the HRU, the Principal Investigator and any co-investigators who are physicians or mid-level 
practitioners (includes PAs, APRNs, psychologists and speech pathologists) who may have direct 
patient contact with patients on YNHH premises must have medical staff appointment and 
appropriate clinical privileges at YNHH. If you are uncertain whether the study personnel meet 
the criteria, please telephone the Physician Services Department at 203-688-2615. By signing 
this protocol as a PI, you attest that you and any co-investigator who may have patient contact 
has a medical staff appointment and appropriate clinical privileges at YNHH. 
 
 
 
 
1. Funding Source: Indicate all of the funding source(s) for this study. Check all boxes that apply. 
Provide information regarding the external funding source.  This information should include 
identification of the agency/sponsor, the funding mechanism (grant or contract), and whether 
the award is pending or has been awarded. Provide the M/C# and Agency name (if grant- 
funded).  If the funding source associated with a protocol is “pending” at the time of the 
protocol submission to the HIC (as is the case for most NIH submissions), the PI should note 
“Pending” in the appropriate section of the protocol application, provide the M/C# and 
Agency name (if grant-funded) and further note that University (departmental) funds support 
the research (until such time that an award is made). 
SECTION III: FUNDING, RESEARCH TEAM AND TRAINING 

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PI 
Title of Grant 
Name of Funding Source 
Funding 
Funding Mechanism 
Jude Clancy, MD 
Bridge occlusion 
balloon initial use 
in humans – 
Investigator 
Initiated Study 
Spectranetics 
P
Federal 
State 
Non Profit 
Industry 
Other For 
rofit 
Other 
I
Grant-M# 
Contract# 
Contract Pending 
Investigator/Department 
nitiated 
Sponsor Initiated 
Other, Specify: 
P
Federal 
State 
Non Profit 
Industry 
Other For 
rofit 
Other 
I
Grant-M# 
Contract# 
Contract Pending 
Investigator/Department 
nitiated 
Sponsor Initiated 
Other, Specify: 
P
Federal 
State 
Non Profit 
Industry 
Other For 
rofit 
Other 
I
Grant-M# 
Contract# 
Contract Pending 
Investigator/Department 
nitiated 
Sponsor Initiated 
Other, Specify: 
 
IRB Review fees are charged for projects funded by Industry or Other For-Profit Sponsors. 
Provide the Name and Address of the Sponsor Representative to whom the invoice should be 
sent.  Note: the PI’s home department will be billed if this information is not provided. 
 
Send IRB Review Fee Invoice To: 
Name: 
ATT: Rashmi Ram 
Company:  Spectranetics Corporation 
Address: 9965 Federal Drive, Colorado Springs, CO 80921 
 
 
2. Research Team:  List all members of the research team. Indicate under the affiliation column whether 
the investigators or study personnel are part of the Yale faculty or staff, or part of the faculty or staff 
from a collaborating institution, or are not formally affiliated with any institution. ALL members of 
the research team MUST complete Human Subject Protection Training (HSPT) and Health 
Insurance Portability and Accountability Act (HIPAA) Training before they may be listed on the 
protocol. See NOTE below. 

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NOTE: The HIC will remove from the protocol any personnel who have not completed required training. 
 
Name 
Affiliation: Yale/Other 
Institution (Identify) 
NetID 
Principal Investigator 
Jude Clancy, MD 
Yale 
JFC25 
Role: Investigator 
Ryan Donovan PA-C 
Yale 
RJD43 
Role: Investigator 
Medhat Abdelmessih, MD 
Yale 
MA648 
 
A personnel protocol amendment will need to be submitted when training is completed. 
SECTION IV: 
PRINCIPAL INVESTIGATOR/FACULTY ADVISOR/ DEPARTMENT CHAIR AGREEMENT 
As the principal investigator of this research project, I certify that: 
 The information provided in this application is complete and accurate. 
 I assume full responsibility for the protection of human subjects and the proper conduct of the 
research. 
 Subject safety will be of paramount concern, and every effort will be made to protect subjects’ 
rights and welfare. 
 The research will be performed according to ethical principles and in compliance with all federal, 
state and local laws, as well as institutional regulations and policies regarding the protection of 
human subjects. 
 
All members of the research team will be kept apprised of research goals. 
 I will obtain approval for this research study and any subsequent revisions prior to my initiating the 
study or any change and I will obtain continuing approval of this study prior to the expiration date of 
any approval period. 
 I will report to the HIC any serious injuries and/or other unanticipated problems involving risk to 
participants. 
 I am in compliance with the requirements set by the University and qualify to serve as the 
principal investigator of this project or have acquired the appropriate approval from the 
Dean’s Office or Office of the Provost, or the Human Subject Protection Administrator at 
Yale-New Haven Hospital, or have a faculty advisor. 
 
I will identify a qualified successor should I cease my role as principal investigator and facilitate a 
smooth transfer of investigator responsibilities. 
 
 
PI Name (PRINT) and Signature 
Date 

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As the faculty advisor of this research project, I certify that: 
 
The information provided in this application is complete and accurate. 
 
This project has scientific value and merit and that the student or trainee investigator has the necessary 
resources to complete the project and achieve the aims. 
 
I will train the student investigator in matters of appropriate research compliance, protection of human 
subjects and proper conduct of research. 
 
The research will be performed according to ethical principles and in compliance with all federal, state 
and local laws, as well as institutional regulations and policies regarding the protection of human 
subjects. 
 
The student investigator will obtain approval for this research study and any subsequent revisions prior to 
initiating the study or revision and will obtain continuing approval prior to the expiration of any approval 
period. 
 
The student investigator will report to the HIC any serious injuries and/or other unanticipated 
problems involving risk to participants. 
 
I am in compliance with the requirements set forth by the University and qualify to serve as 
the 
faculty advisor of this project. 
 
I assume all of the roles and responsibilities of a Principal Investigator even though the student may be 
called a PI. 
 
 
Advisor Name (PRINT) and Signature 
Date 
 
 
 
 
Department Chair’s Assurance Statement 
Do you know of any real or apparent institutional conflict of interest (e.g., Yale ownership of a 
sponsoring company, patents, licensure) associated with this research project? 
Yes (provide a description of that interest in a separate letter addressed to the HIC.) 
No 
 
As Chair, do you have any real or apparent protocol-specific conflict of interest between yourself and 
the sponsor of the research project, or its competitor or any interest in any intervention and/or method 
tested in the project that might compromise this research project? 
Yes (provide a description of that interest in a separate letter addressed to the HIC) 
No 
 
I assure the HIC that the principal investigator and all members of the research team are qualified by 
education, training, licensure and/or experience to assume participation in the conduct of this research 
trial. I also assure that the principal investigator has departmental support and sufficient resources to 
conduct this trial appropriately. 
 
 
Chair Name (PRINT) and Signature 
Date 
 
 
Department 

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YNHH Human Subjects Protection Administrator Assurance Statement 
Required when the study is conducted solely at YNHH by YNHH health care providers. 
 
 
 
 
 
1. Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested. 
 
To evaluate the use of an occlusion balloon (Bridge Occlusion Balloon, Spectranetics) within the 
SVC in lead extraction patients. 
 
2. Background: Describe the background information that led to the plan for this project. 
Provide references to support the expectation of obtaining useful scientific data. 
 
Chronically implanted pacemaker and ICD leads often are encased in dense adherent fibrous 
tissue growth. This can lead to significant difficultly in extracting these leads and major 
complications and death may occur during transvenous lead extraction. A recent study of 
catastrophic complications occurring during lead extraction demonstrated a rate of 0.8% major 
complication and 0.4% for procedural mortality over a 16-year period in patients requiring an 
intervention (1). Injury to the superior vena cava (SVC), a major thoracic vessel is uncommon 
and occurs at the rate of 0.4 % (2). However, an SVC tear can be associated with hemodynamic 
instability, hemothorax, and tamponade. This is a life-threatening and potentially fatal 
complication if not recognized and treated promptly. Expeditious control of bleeding is of 
paramount importance to achieve a reasonable long-term outcome. Repair of an SVC 
perforation requires an open chest approach with emergency sternotomy or thoracotomy. 
According to the Heart Rhythm Society guidelines (3), a delay from the time of injury to open 
access to the heart (patient related comorbidities or re-operative open access) of more than 5- 
10 minutes was associated with a fatal outcome. Initiation of rescue efforts within this time 
period with prompt endovascular management with a device such as the Bridge occlusion 
balloon can result in a successful outcome. Inflating the Bridge device immediately when a 
tear is suspected can provide temporary occlusion in the tear area, resulting in control of 
hemorrhage, and maintenance of patient’s hemodynamics prior to definitive surgical repair. 
 
(1) Brunner MP, Cronin EM, Wazni O, Baranowski B, Saliba WI, Sabik JF, Lindsay BD, Wilkoff BL, Tarakji 
KG. Outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic 
complications during transvenous lead extraction. Heart Rhythm. 2014 Mar;11(3):419-25 
As Human Subject Protection Administrator (HSPA) for YNHH, I certify that: 

I have read a copy of the protocol and approve it being conducted at YNHH. 

I agree to notify the IRB if I am aware of any real or apparent institutional conflict of interest. 

The principal investigator of this study is qualified to serve as P.I. and has the support of the hospital 
for this research project. 
YNHH HSPA Name (PRINT) and Signature 
Date 
SECTION V: RESEARCH PLAN 

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(2) Wazni, O et al. (2010). Lead extraction in the contemporary setting: the LExICon study: an observational 
retrospective study of consecutive laser lead extractions. J Am Coll Cardiol. Feb 9;55(6):579-86 
 
(3) Wilkoff BL, Love CJ, Byrd CL, Bongiorni MG, Carrillo RG, Crossley GH 3rd, Epstein LM, Friedman RA, 
Kennergren CE, Mitkowski P, Schaerf RH, Wazni OM; Heart Rhythm Society; American Heart Association. 
Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and 
patient management: this document was endorsed by the American Heart Association (AHA). Heart Rhythm. 
2009 Jul;6(7):1085-104. 
 
3. Research Plan: Summarize the study design and research procedures using non-technical 
language that can be readily understood by someone outside the discipline. Be sure to 
distinguish between standard of care vs. research procedures when applicable, and 
include any flowcharts of visits specifying their individual times and lengths. Describe 
the setting in which the research will take place. 
 
This study will evaluate the use of an occlusion balloon (Bridge Occlusion Balloon, 
Spectranetics) within the SVC (Superior Vena Cava) in lead extraction patients. This will be 
performed in a non-emergent setting to allow for evaluation of how best to integrate this new 
technology into our clinical practice. The study will focus on the effect of the Bridge balloon 
on the patient preparation clinical workflow, ease of insertion/positioning/deployment, and the 
ability to recognize proper inflation and vein sealing under fluoroscopy. Understanding these 
factors will help build a more robust clinical workflow with the goal of better patient outcomes 
in the case of an injury to SVC. The images and data generated during this study can help in 
dissemination of the practical use knowledge to fellow lead extractors. 
 
The study procedure steps will be as follow: 
 
1. Record baseline vital signs (HR, BP, SPO2) and ABG post intubation but prior to study 
initiation 
2. Obtain baseline cine of superior vena cava (SVC) to document SVC integrity before using 
the balloon. 
3. Place a compatible guidewire via the right femoral vein and confirm position of the 
guidewire with fluoroscopy. Obtain cine of guidewire position from access vein to 
destination vein. 
4. Use a 12F sheath over the guidewire in the right femoral vein. 
5. Start time recording with a stopwatch (time=0); Open the sterile balloon packaging. Insert 
and advance the balloon until the proximal marker band (radiopaque mark) is located at 
the SVC/RA junction. Use cine to document balloon position. 
6. Record vital signs (HR, BP, SPO2) prior to balloon inflation. 
7. Using fluoroscopic guidance, properly inflate the balloon with 20/80 contrast/saline mix 
using the recommended 60cc syringe until the balloon conforms to the vasculature. 
8. Record the time to balloon deployment (i.e. complete conformance of the balloon to the 
vasculature based on fluoroscopy). 
9. Use fluoroscopy and cine to confirm and record the position of the balloon. 
10. Record vital signs (HR, BP, SPO2) post balloon inflation but prior to contrast injection. 

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11. Inject contrast from superior venous access and record cine to assess occlusion of the SVC. 
12. Allow one repositioning of balloon if occlusion not obtained and record additional cine to 
reassess occlusion of SVC. 
13. Record vital signs (HR, BP, SPO2) 1 min after occlusion has been confirmed. 
14. Deflate the balloon fully using the 60cc syringe and remove the balloon from the body. 
Leave guidewire and femoral sheath in place (can be used to deliver a bridge balloon 
catheter in case if SVC tear occurred during the extraction procedure – this is a clinical 
indication and is not an investigational part). Repeat venogram after balloon deflation and 
removal to document SVC area post occlusion. 
15. Record vital signs (HR, BP, SPO2) and ABG 5,10,15,20,25, and 30 minutes post balloon 
deflation. 
16. Record all vital signs (HR,BP,SPO2) that is out of the expected reange for the patient within 
30 minutes post balloon deflation. 
17. Continue with the lead extraction procedure. 
 
The extraction procedure itself is a standard of care procedure, it is clinically indicated in the 
targeted patient population. The deployment and use of the Balloon Bridge is a research related 
activity, will be done for the research purposes only. 
 
All the procedures pertaining to lead extraction is standard of care and routinely used. The 
research portion of the study will consist of balloon inflation prior to initiation of the lead 
extraction procedure. There will be no control group for this study. The device itself will be 
provided at no cost. 
 
This study will evaluate the use of the Bridge occlusion balloon in 3-5 lead extraction patients 
scheduled for lead extraction (patients indicated for lead extraction). This study will be 
performed prior to lead extraction in an intact SVC without prior SVC occlusion. 
The following data will be collected: 
 Cine at baseline and after removal of the Bridge occlusion balloon. 
 Cine of the insertion/positioning/inflation of the Bridge occlusion balloon. 
 Venogram:  pre-occlusion,  during  occlusion  confirming  vein  occlusion,  and  post- 
occlusion to evaluate vein integrity. 
 Hemodynamics (BP, HR, and SPO2) at a pre-occlusion baseline, during occlusion, and 
post-occlusion and recovery time (5min). 
 Time to insert, position, and deploy Bridge from sterile packaging. 
 Any perioperative and post-24hr clinical complications the PI at each center feels is 
directly related to deployment of the Bridge occlusion balloon. 
 
Study Endpoints: 
Primary Endpoints 
 
 Robust clinical workflow is established 
 The Bridge occlusion balloon will: 
 Fit within an acceptable patient preparation clinical workflow. 
 Will be easy to insert, position, and deploy in vivo. 

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 Will be successful to achieve intact SVC occlusion with the Bridge balloon. 

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15 | P a g e 
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Occlusion Balloon Catheter Description 
 
The Bridge Occlusion Balloon catheter is designed to be delivered percutaneously to the superior 
vena cava (SVC) for the purpose of providing occlusion of the SVC and providing emergency 
control of hemorrhage and perioperative occlusion in the event of an SVC tear or perforation 
during a lead extraction procedure. 
The Bridge Occlusion Balloon catheter is constructed of a compliant 
polyurethane balloon mounted on a dual lumen polyurethane shaft. The 
hub port, marked BALLOON, is connected to the balloon inflation lumen. 
The unmarked hub port is connected to the central lumen of the catheter, 
which terminates at the distal tip. This lumen is used to pass the catheter 
over a guidewire. A strain relief is mounted to the catheter shaft just distal 
of the proximal hub. Three platinum-iridium radiopaque markers are 
placed within the balloon segment of the catheter to provide visual 
reference points for balloon positioning within the SVC prior to inflation. 
 
Plan to ensure training of staff at all sites: 
 
 All site study coordinators are required to attend study protocol training over the phone 
(web conference). This training will be provided by the investigators at Yale and will cover 
the study purpose, the study protocol, and the data collection process in detail. This training 
will be documented in “Bridge Balloon Study – Protocol Training” form. 
 All site study coordinators are then required to train their site physician(s) (if the 
physician(s) are unable to the phone training) on the study protocol. This training will be 
documented in the “Bridge Balloon Study – Protocol Training” form. 
 Time will be given after each training session for questions and more clarification as 
needed. 
 All site physicians are required to be trained on the Bridge Occlusion Balloon Catheter. 
This training will be performed by a qualified Spectranetics’ sales representative and will 
be documented in the “Bridge Balloon Study – Device Training” form. 
 Documentation of protocol and device training is required prior to enrolling patients. 
 Documentation of the training will be kept in the regulatory binder. 
 
 
Plan to ensure IRB approval is in place prior to starting: 
 
 IRB approval tracking system is in place, excel sheet is created to track the IRB approvals 
at each site. 
 Each site is required to send to Yale a copy of the IRB approval letter. 
 Authorization letter will be sent out to start enrollment at other sites after receiving the 
appropriate IRB documentation. 

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Mechanism for registering each subject at Yale: 
 
 Each subject has two different registration codes; 
 First ID: is done by each site which includes the site ID (2digits) and subject ID (3 
digits) e.g. [XX-XXX] - This will allow us to know the enrolling site and 
enrollment order of each subject. 
 Second ID: is done here at Yale based on the order of receiving the data collection 
form e.g. [XXX] 
 
Mechanism for routine communication with site investigators: 
 
 The PI will send a weekly mass e-mail for the site investigators to discuss the study 
progress. 
 A copy of the email communication will be kept in the regulatory binder. 
 
Plan to ensure ongoing IRB approval at all sites and approval of any amendments: 
 
 Based on the IRB approvals tracking system, 1st email reminder will be sent 3 months 
before study expiration date as a reminder of study reapproval. Follow up emails each week 
until a documentation of IRB submission is received. 
 All sites are required to update the central site with any amendments submissions and a 
copy of the approval will be saved in the regulatory binder. 
 
 
 
 
4.   Genetic Testing   N/A 
 
 
 
 
5. Subject Population: Provide a detailed description of the types of human subjects who will 
be recruited into this study. 
 
Patients indicated for lead extraction.  5 patients per site can be tested as part of this 
study. 
 
6. Subject classification: Check off all classifications of subjects that will be specifically 
recruited for enrollment in the research project. Will subjects who may require additional 
safeguards or other considerations be enrolled in the study? If so, identify the population of 
subjects requiring special safeguards and provide a justification for their involvement. 
 
Children 
Healthy 
Fetal material, placenta, or dead fetus 
Non-English Speaking 
Prisoners 
Economically disadvantaged persons 
Decisionally Impaired 
Employees 
Pregnant women and/or fetuses 
Yale Students 
Females of childbearing potential 

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NOTE: Is this research proposal designed to enroll children who are wards of the state as 
potential subjects? 
Yes 
No (If yes, see Instructions section VII #4 for further 
requirements) 
 
 
7. Inclusion/Exclusion Criteria: What are the criteria used to determine subject inclusion or 
exclusion? 
Inclusion: 
 Subject age more than 18 years. 
 Lead extraction patients. 
Exclusion: 
Lead extraction patients with 
 SVC occlusion or stenosis. 
 Significant vegetation. 
 Hemodynamic instability. 
 Class IV NYHA heart failure 
 Creatinine > 2.0mg/dL 
 Mechanical assist devices 
 Patients > 85 years old 
 Patients felt to be high risk due to degree of acute illness or systemic comorbidities  
 Patients who are placed on a heparin bridge, and are felt to be high risk for even brief 
discontinuation of anticoagulation  
 
8. How will eligibility be determined, and by whom? 
 
Eligibility will be determined by the PI and investigators based on the exclusion/inclusion 
criteria. Clinical evaluation will be done to evaluate the patient’s eligibility for the study. 
 
9. Risks: Describe the reasonably foreseeable risks, including risks to subject privacy, 
discomforts, or inconveniences associated with subjects participating in the research. 
 
The adverse events associated with an occlusion balloon procedure include, but are not limited 
to the following: 
 Allergic Reactions 
 Death 
 Embolization / thromboembolic episodes 
 Hematoma 
 Hemorrhage 
 Sepsis/infection 
 Short term hemodynamic deterioration 
 Vascular thrombosis 
 Vessel dissection 
 Vessel Perforation 
 Vessel Spasm 
 

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There is a potential risk of privacy breach will be avoided by following HIPPA rules. All 
patients’ personal information will be kept in safe encrypted devices. All the collected data will 
be kept on a protected device connected to secure server networks located in locked office. 

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10. Minimizing Risks: Describe the manner in which the above-mentioned risks will be 
minimized. 
 
Risks can be minimized through compliance with this protocol, using the devices in accordance 
with their applicable directions for use, performing the procedures following recommended 
standard practices/guidelines, performing procedures in the appropriate hospital environment, 
adherence to subject selection criteria, close monitoring of the subject’s physiologic status during 
research procedures and/or follow-ups. 
 
All the data will be kept in protected computers that are located in locked offices. 
 
11. Data and Safety Monitoring Plan: Include an appropriate Data and Safety Monitoring Plan 
(DSMP) based on the investigator’s risk assessment stated below. (Note: the HIC will make 
the final determination of the risk to subjects.) For more information, see the Instructions, 
page 24. 
a. 
What is the investigator’s assessment of the overall risk level for subjects 
participating in this study? 
The risk assessment is greater than minimal. 
b. 
If children are involved, what is the investigator’s assessment of the overall risk 
level for the children participating in this study? 
No children will be enrolled in this study. 
c. 
Include an appropriate Data and Safety Monitoring Plan. Examples of DSMPs are 
available here http://www.yale.edu/hrpp/forms-templates/biomedical.html  for 
i. Minimal risk 
ii. Greater than minimal 
 
Greater Than Minimal Risk DSMP 
 
1. Personnel responsible for the safety review and its frequency: 
 
The principal investigator will be responsible for monitoring the data, assuring protocol 
compliance, and conducting the safety reviews at the specified frequency, which must be 
conducted at a minimum of every 6 months (including when reapproval of the protocol is sought). 
During the review process, the principal investigator (monitor) will evaluate whether the study 
should continue unchanged, require modification/amendment, or close to enrollment. Either the 
principal investigator, the IRB or have the authority to stop or suspend the study or require 
modifications. 
 
All sites are required to document all the adverse events and complication in the data collection 
form with the site PI assessment. Each site will send de-identified source documents to the central 
site through secured academic email or fax to the central site. The fax is located in a locked office, 
to which only the research team has access. 
 
Through the remote monitoring plan, the central PI will review all the adverse events and 
perioperative complication within 1 day of receiving the data collection form. Additional source 

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documents will be requested from the site. All the source documents will be stored in a locked 
research office in the cardiology department. 
 
 
2. The risks associated with the current study are deemed greater than minimal for the 
following reasons: (choose those that apply) 
 
1. We do not view the risks associated with the Bridge Balloon as minimal risks. 
Although we have assessed the proposed study as one of greater than minimal risk, the potential 
exists for anticipated and/or unanticipated adverse events, serious or otherwise, to occur since it is 
not possible to predict with certainty the absolute risk in any given individual or in advance of 
first-hand experience with the proposed study methods. Therefore, we provide a plan for 
monitoring the data and safety of the proposed study as follows: 
 
An independent study monitor will have the oversight of the study. A remote monitoring plan is 
in place to validate the information collected from all sites. 
 
The monitor will receive the documents form each site and will check the accuracy and 
completeness of the data entries, source documents, and other trial-related records against each 
other. The monitor specifically will verify that the data required by the protocol are reported 
accurately on the data collection sheet and are consistent with the source data/documents. 
 
The study monitor will verify that all the adverse events, concomitant medications, and current 
illnesses are reported in accordance with the protocol. In addition, the monitor will determine 
whether all adverse events (AEs) are appropriately reported within the time periods. 
 
The appointed monitor will verify that source documents and other trial records are accurate, 
complete, kept up-to-date, and maintained. Also will verifying that the investigator is enrolling 
only eligible subjects and report the subject recruitment rate. 
 
The monitor will submit a written report to the sponsor after each monitoring action. The report 
will include a summary of what the monitor reviewed and the monitor's statements concerning the 
significant findings, deviations and deficiencies, conclusions, actions taken or to be taken. 
 
Review of documentation will begin for each site after the first subject's data is sent to the 
coordinating center. The review will take place within 5 days of receipt of the information. The 
monitor, after reviewing the data, will email the investigator with any queries. When all queries 
are responded to satisfactorily, the monitor will review additional subjects after the third subject 
is enrolled at the site. 
 
 
All the qualification of the appointed monitor will be kept in the master binder. 
 
 
3. Attribution of Adverse Events: 

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Adverse events will be monitored for each subject participating in the study and attributed to the 
study procedures / design by the principal investigator (Dr. Jude Clancy) according to the 
following categories: 
 
a.) Definite: Adverse event is clearly related to investigational procedures(s)/agent(s). 
b.) Probable: Adverse event is likely related to investigational procedures(s)/agent(s). 
c.) Possible: Adverse event may be related to investigational procedures(s)/agent(s). 
d.) Unlikely: Adverse event is likely not to be related to the investigational 
procedures(s)/agent(s). 
e.) Unrelated: Adverse event is clearly not related to investigational procedures(s)/agent(s). 
 
4. Plan for Grading Adverse Events: 
 
The following scale will be used in grading the severity of adverse events noted during the study: 
 
1. Mild adverse event 
2. Moderate adverse event 
3. Severe 
5. Plan for Determining Seriousness of Adverse Events: 
Serious Adverse Events: 
In addition to grading the adverse event, the PI will determine whether the adverse event meets 
the criteria for a Serious Adverse Event (SAE). An adverse event is considered serious if it 
results in any of the following outcomes: 
 
1. Death; 
2. A life-threatening experience in-patient hospitalization or prolongation of existing 
hospitalization; 
3. A persistent or significant disability or incapacity; 
4. A congenital anomaly or birth defect; OR 
5. Any other adverse event that, based upon appropriate medical judgment, may jeopardize 
the subject’s health and may require medical or surgical intervention to prevent one of 
the other outcomes listed in this definition. 
 
An adverse event may be graded as severe but still not meet the criteria for a Serious Adverse 
Event.  Similarly, an adverse event may be graded as moderate but still meet the criteria for an 
SAE.  It is important for the PI to consider the grade of the event as well as its “seriousness” 
when determining whether reporting to the IRB is necessary. 
 
6. Plan for reporting UPIRSOs (including Adverse Events) to the IRB 
 
The principal investigator will report the following types of events to the IRB: 
Any incident, experience or outcome that meets ALL 3 of the following criteria: 
1. Is unexpected (in terms of nature, specificity, severity, or frequency) given (a) the 
research procedures described in the protocol-related documents, such as the IRB- 

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approved protocol and informed consent document and (b) the characteristics of the 
subject population being studied; AND 
2. Is related or possibly related to participation in the research (possibly related means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); AND 
3. Suggests that the research places subjects or others at greater risk of harm (including 
physical, psychological, economic, legal, or social harm) than was previously known 
or recognized. 
Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs) may be medical or 
non-medical in nature, and include – but are not limited to – serious, unexpected, and related 
adverse events and unanticipated adverse device effects. Please note that adverse events are 
reportable to the IRB as UPIRSOs only if they meet all 3 criteria listed above. 
 
These UPIRSOs/SAEs will be reported to the IRB in accordance with IRB Policy 710, using the 
appropriate forms found on the website. All related events involving risk but not meeting the 
prompt reporting requirements described in IRB Policy 710 should be reported to the IRB in 
summary form at the time of continuing review. If appropriate, such summary may be a simple 
brief statement that events have occurred at the expected frequency and level of severity as 
previously documented. In lieu of a summary of external events, a current DSMB report can be 
submitted for research studies that are subject to oversight by a DSMB (or other monitoring entity 
that is monitoring the study on behalf of an industry sponsor). 
 
7. Plan for reporting adverse events to co-investigators on the study, as appropriate the 
protocol’s research monitor(s), e.g., industrial sponsor, Yale Cancer Center Data and 
Safety Monitoring Committee (DSMC), Protocol Review Committee (PRC), DSMBs, study 
sponsors, funding and regulatory agencies, and regulatory and decision-making bodies. 
 
For the current study, the following individuals, funding, and/or regulatory agencies will be 
notified (choose those that apply): 
 
■ All Co-Investigators listed on the protocol. 
□ Yale Cancer Center Data and Safety Monitoring Committee (DSMC) 
□ National Institutes of Health 
□ Food and Drug Administration (Physician-Sponsored IND # 
) 
□ Medical Research Foundation (Grant          _) 
■ Study Sponsor 
■ Other Data Safety Monitoring Board (DSMB) or Committee (DSMC) 

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An independent DSMC has been established to oversight the study. The members of the 
DSMC are as follow: 
 
Rachel Lampert, MD 
Professor of Medicine, Yale University 
 
Lynda Rosenfeld, MD 
Professor of Medicine, Yale University 
 
Charles Love, MD 
Professor of Medicine, New York University 
 
The committee will meet within the 1st week after the study initiation to establish a reviewing 
plan and a standard operating procedure for what the rules are for stopping the study and how 
adverse events will be reviewed. In addition, the committee will meet as frequent as needed to 
review any emerging safety issues and adverse events and finally at the time of study closure. 
Minutes will be maintained. 
 
The data monitoring committee will review all the data after half the subjects in the study are 
enrolled according to the stopping and continuance rules established by the Committee. 
 
The committee recommendations will be communicated to other sites on a regular basis. 
The central PI, Dr. Jude Clancy will create a secured Yale Box for data and document transfer. 
A copy of the committee members’ CV and qualifications will be kept in the master file. 
 
 
The principal investigator (Dr. Jude Clancy) will conduct a review of all adverse events upon 
completion of every study subject. The principal investigator will evaluate the frequency and 
severity of the adverse events and determine if modifications to the protocol or consent form are 
required. 
 
d. For multi-site studies for which the Yale PI serves as the lead investigator: 
i. How will adverse events and unanticipated problems involving risks to subjects or 
others be reported, reviewed and managed? 
 Any perioperative and post-24hr clinical complications the PI at each 
center feels is directly related to deployment of the Bridge occlusion 
balloon must be reported to the PI, the local site IRB and Yale HIC. 
 The PI will evaluate any unanticipated problems, will submit it to the 
HIC immediately. 
 Any adverse events or complications will be communicated to the co 
investigators through the weekly emails. 
The anticipated risks: 
 Sudden drop in arterial blood pressure. 
 Venous stasis that can induce arrhythmias and/or cardiac arrest. 
 Cerebral venous hypertension. 
 Temporary facial edema or facial cyanosis (bluish discoloration of the face). 

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 Groin hematoma or bleeding. 
 Thrombus within SVC. 
There is a section in the data collection form to document any other unknown 
adverse events. 
 
ii. What provisions are in place for management of interim results? 
 The PI and investigators will review the data quarterly for safety issues. 
No statistical claims are being made with the data being collected, and 
there is no minimum  
 
 

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  
 
 

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 sample size required. 
 
iii. What will the multi-site process be for protocol modifications? 
 
 The PI will request any protocol modifications to be applied to all sites. 
Protocol amendment will be requested with the need of local IRB 
acknowledgements to be collected from all sites. 
 All the IRB related documentations are kept in the master regulatory 
binder in the research office. Copies of the PIs curriculum vitae and 
qualifications are kept in the regulatory binder. 
 All sites are required to send their IRB approvals to the central site. 
 
12. Statistical Considerations: Describe the statistical analyses that support the study design. 
 
A sample size of 3-5 patients per site was selected to allow for a sufficient physician experience 
to generate an ease of use and efficacy of occlusion determination (target 25 total) 
No statistical claims are being made with the data being collected, there is no minimum sample 
size required. 
 
 
 
If this section (or one of its parts, A or B) is not applicable, state N/A and delete the rest of the 
section. 
 
 
A. DRUGS, BIOLOGICS and RADIOTRACERS  N/A 
 
B. DEVICES 
 
1. 
Are there any investigational devices used or investigational procedures performed at Yale- 
New Haven Hospital (YNHH) (e.g., in the YNHH Operating Room or YNHH Heart and 
Vascular Center)?  ☐Yes   ☒No 
If Yes, please be aware of the following requirements: 
 
a. A YNHH New Product/Trial Request Form must be completed via EPIC: Pull down the 
Tools tab in the EPIC Banner, Click on Lawson, Click on “Add new” under the New 
Technology Request Summary and fill out the forms requested including the “Initial 
SECTION VI: RESEARCH INVOLVING DRUGS, BIOLOGICS, RADIOTRACERS, PLACEBOS AND 
DEVICES 

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Request Form,” “Clinical Evidence Summary, “ and attach any other pertinent 
documents. Then select “save and submit” to submit your request; and 
 
b. Your request must be reviewed and approved in writing by the appropriate YNHH 
committee before patients/subjects may be scheduled to receive the investigational device 
or investigational procedure. 
 
 
2. What is the name of the device to be studied in this protocol? 
Bridge Occlusion Balloon Catheter. 
Has this device been FDA approved? 
Yes 
No 
If yes, state for what indication. 
 
Bridge Occlusion Balloon received FDA 510(k) clearance on 02/05/2016 for temporary vessel 
occlusion in cardiac lead extraction procedures (K153530). 
 
Indication: The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel 
occlusion of the superior vena cava in applications including perioperative occlusion and 
emergency control of hemorrhage. 
Any use for procedures other than those indicated in these instructions is not recommended. 
 
 
 
 
Background Information: Provide a description of previous human use, known risks, and any 
other factors that might influence risks. If this is the first time this device is being used in 
humans, include relevant data on animal models. 
 
Five animal studies comprise the pre-clinical data sources. The study IDs are NGX017 
(Intravascular Tear Model), NGX021 (Efficacy of Occlusion Balloon Shape), NGX023 (Safety 
of Occlusion Balloon Deployment), NGX027 (Efficacy of Bridge Occlusion Balloon), and 
NGX028 (Safety of Bridge Occlusion Balloon). 
 
Results Summary: 
 
Five pre-clinical animal studies were conducted at American Preclinical Services (APS), 
located in Minneapolis, MN, USA. Three of the animal studies were used to develop the 
clinical model, and to assess device design and safety. Two of the animal studies were 
conducted in accordance with FDA GLP regulations to assess the efficacy and safety of the 
final device design. 
All studies were conducted in the porcine animal model due to the anatomical and 
physiological similarities to the human cardiovascular system. Study results demonstrated that 
the Bridge Occlusion Balloon significantly reduced blood loss when deployed at the site of a 
SVC tear, which allowed all animals to be kept in a clinically stable condition for the full 

28 | P a g e 
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duration of every procedure. Deployment of the Bridge Occlusion Balloon did not produce any 
clinically significant histological findings or neurological or physical deficiencies. Taken 
together, these results suggest that the Bridge Occlusion balloon is safe and effective for 
temporary occlusion of the SVC. 
 
The Bridge occlusion balloon is designed based on human SVC (superior vena cava) 
measurements to inflate and cover the entire SVC with a single device with a balloon working 
length of 80mm. 
 
Clamping a patent unobstructed SVC can have adverse hemodynamic consequences such as a 
sudden drop in mean arterial blood pressure and venous stasis that can induce arrhythmias 
and/or cardiac arrest. Additional consequences may be cerebral venous hypertension, decrease 
in cerebral perfusion, and alteration of cerebral arteriovenous gradient leading to brain 
damage(1, 2, and 3) While there is limited evidence for temporary balloon occlusion during an 
SVC tear, the efficacy of temporary venous occlusion to minimize or stop blood flow during a 
cardiac surgical repair, reconstruction, or a minimally invasive procedural treatment with little 
to no neurological impairment or cerebral damage has been studied in the literature. Although 
there is a risk to occluding the SVC, the studies described herein demonstrate that such 
procedures can be done safely. (4) 
 
Snaring of the caval veins to occlude flow prior to right atrial incision during tricuspid valve 
surgery is associated with a risk of sudden injury and untreatable bleeding. As an alternative, 
Foley and Fogarty balloon catheters (5, 6) and Swan-Ganz (7) catheters have been described in 
the use of temporary SVC occlusion. The utility of Swan-Ganz catheter with SVC clamping 
was described in 7 patients undergoing thoracic surgical SVC reconstruction or replacement 
with SVC bypass. This system allowed hemodynamic stability with no overall change in blood 
pressure, heart rate, and oxygen saturation values. In one patient, facial edema and cyanosis 
was observed during SVC clamping, although this rapidly resolved following SVC 
reconstruction. Clinical postoperative neurological examination after extubation revealed no 
neurological impairment or deficit in any patient. One patient presented with severe agitation 
during awakening and required additional sedation and extubation time. There was no 90 day 
postoperative mortality. The mean SVC occlusion time was 24±3 minutes in this study. 
 
Other uses for occlusion balloon in the SVC have been described during minimally invasive 
surgical procedure for removal of migrated foreign bodies. Lu et al. (8) reported placement of 
a balloon catheter in the internal jugular vein and SVC to keep a foreign body from embolizing 
to the heart or pulmonary arteries during surgical removal. The entire procedure took 30 
minutes, including 15 minutes for balloon inflation. The patient made an uneventful 
postoperative recovery and was discharged at day 5 post-procedure with no evidence of 
complication. 
 
 
Finally, it is also pertinent to recognize the presence of collateral routes of the SVC in humans 
for maintenance of venous drainage in the event of SVC occlusion (9, 10). The azygos- 
hemiazygos pathway is the predominant system and includes the azygos (that drains directly 
into the SVC), hemiazygos, intercostal, and lumbar veins. Accidental ligation of the SVC 

29 | P a g e 
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during pneumonectomy has been reported to be tolerated for a few hours before being noticed 
and repaired (11). 
 
Given the Bridge device is a temporary occlusion balloon for deployment within the SVC, it 
can be safely inflated for up to 30 minutes. Other collateral pathways are the internal thoracic, 
vertebral, and lateral thoracic venous systems. The internal thoracic venous system drains into 
the inferior vena cava from the internal thoracic vein through the superior epigastric vein, 
inferior epigastric vein, external iliac vein, and common iliac vein. The vertebral venous 
system drains blood from the sinus venous and bilateral brachiocephalic veins into the 
intercostal vein, lumbar vein, and sacral vein into the inferior vena cava. 
The lateral thoracic venous system is the superficial collateral circulatory system where blood 
from the subclavian and axillary vein reaches the lateral thoracic vein and drains into the 
femoral vein. Since the collateral pathways maintain flow in the presence of an SVC 
obstruction, a temporary occlusion to the SVC, as demonstrated above, appears to be safe and 
achievable within a limited timeframe and is critical in the event of an SVC tear for 
maintenance of hemostasis and patient stabilization. 
 
The literature summarized here supports the conclusion that the SVC can be occluded for 30 
minutes without negatively affecting physiologic or neurologic states and therefore should be 
considered a safe procedure for timely rescue of the patient. 
 
1 Gonzalez-Fajardo JA, Garcia-Yuste M, Florez S, Ramos G, Alvarez T, et al. Hemodynamic and cerebral repercussions 
arising from surgical interruption of the superior vena cava. Experimental model. J Thorac Cardiovasc Surg 1994;107: 1044- 
1049 
 
2 Galatoudis Z, Soumpasis I, Vretzakis G. Anesthetic considerations for surgery involving clamping of superior vena cava. 
Greek E-Journal Perioper Med 2005;3:49-59 
 
3 Leo F, Della Grazia L, Tullii M, Gasparri R, Borri A, Venturino M, Spaggiari L. Hemodynamic instability during superior vena 
cava cross-clamping: predictors, management, and clinical consequences. J Thorac Cardiovasc Surg 2007;133:1105–1106 
 
4 Ishiguchi T, Nishikimi N, Usui A, Ishigaki T. Endovascular stent-graft deployment: temporary vena caval occlusion with 
balloons to control aortic blood flow-experimental canine study and initial clinical experience. Radiology. 2000 May;215(2):594- 
9. 
 
5 Sansone F, del Ponte S, Zingarelli E, Casabona R. Internal snaring of the caval veins by Foley catheters in case of 
reoperation via right thoracotomy. Interact Cardiovasc Thorac Surg. 2011 Oct;13(4):370-2. 
 
6 Capestro F, Matteucci S, Rescigno G, Torracca L. A simplified technique for caval occlusion in reoperative small 
thoracotomies. J Thorac Cardiovasc Surg. 2011 Aug;142(2):460-2. 
 
7 Perentes JY, Erling CC, Ris HB, Corpataux JM, Magnusson L. A simple bypass technique for superior vena cava 
reconstruction. Interact Cardiovasc Thorac Surg. 2011 Jan;12(1):15-9. 
 
8 Lu G, Bao J, Pei Y, Jing Z. Temporary balloon occlusion of both the superior vena cava and the internal jugular vein to 
achieve removal of a migrated foreign body. Ann Vasc Surg 2009;23:687.e9-13. 
9 McIntire FT, Sykes EM Jr. Obstruction of the superior vena cava; a review of the literature and report of two personal cases. 
Ann Intern Med. 1949 May;30(5):925-60. 

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10 Dahan H, Arrivé L, Monnier-Cholley L, Le Hir P, Zins M, Tubiana JM. Cavoportal collateral pathways in vena cava 
obstruction: imaging features. Am J Roentgenol. 1998 Nov;171(5):1405-11. 
 
11 Ohri SK, Lawrence DR, Townsend ER. Homograft as a conduit for superior vena cava syndrome. Ann Thorac Surg 1997; 
64: 531-533 
 
 
 
3. Source: 
a) Identify the source of the device to be used. 
Bridge Occlusion Balloon. 
 
b) Is the device provided free of charge to subjects? 
Yes 
No 
 
4.  What is the PI’s assessment of risk level (significant or non-significant) associated with the 
use of the device? 
 
Significant Risk (SR) Device Study: A study of a device that presents a potential for serious 
risk to the health, safety, or welfare of a participant and 1) is intended as an implant; 2) is used in 
supporting or sustaining human life; or otherwise prevents impairment of human health; 3) is of 
substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise prevents 
impairment of human health; or 4) otherwise presents a potential for serious risk to the health, 
safety, or welfare of a participant. 
 
Significant Risk Devices require an Investigational Device Exemption (IDE) issued by the FDA. 
What is the IDE number assigned by the FDA? 
Did the FDA approve this IDE as Category A (experimental/investigational) or as Category B 
(non-experimental/investigational)? 
Who holds the IDE? 
Non-Significant Risk (NSR) Device Study: A study of a device that does not meet the 
definition for a significant risk device and does not present a potential for serious risk to the health, 
safety, or welfare of participants.  Note that if the HIC concurs with this determination, an IDE is 
not required. 
 
5. Abbreviated IDE or Exempt IDE: There are abbreviated requirements for an IDE and 
there also are exemptions to the requirement for an IDE.  See the criteria in the HIC 
Application Instructions, Section VI.B.4 at  
http://www.yale.edu/hrpp/resources/docs/100FR1aHICProtocol_Application_Instructions5-   
25-11.pdf to determine if these pertain to this study. 
 
Abbreviated IDE or Exempt IDE – If criteria set forth in the HIC Application Instructions 
are met, copy and paste the completed relevant section from the Instructions into this application. 
b.)  Does the device fulfill one of the IDE exemption categories  (21 CFR 812.2(c))? 

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• The device, other than a transitional device, was introduced into commercial distribution on 
or after May 28, 1976, the FDA determined the device to be substantially equivalent to a 
device in commercial distribution immediately before May 28, 1976, and the device will be 
used or investigated in accordance with the indications in the labeling FDA reviewed under 
subpart E of part 807 in determining substantial equivalence. 
_X     Yes 
No 
 
 
6. 
Investigational device accountability: 
State how the PI, or named designee, ensures that an investigational device is used only in 
accordance with the research protocol approved by the HIC, and maintains control of the 
investigational device as follows: 
The PI and research staff will receive training regarding the device prior to the start of the 
study. Training will include protocol specific handling of the device. 
Maintains appropriate records, including receipt of shipment, inventory at the site, dispensation 
or use by each participant, and final disposition and/or the return of the investigational device (or 
other disposal if applicable): 
Receipt of device shipment, inventory at the site, device dispensation/participant use, and 
return of the investigational device will be documented and maintained by research staff in 
the on-site study binder/files. 
Documents pertinent information assigned to the investigational device (e.g., date, quantity, batch 
or serial number, expiration date if applicable, and unique code number): 
The Principal Investigator or an authorized designee shall keep records documenting the 
receipt, storage, use, return and disposal of the investigational devices/equipment, which 
shall include the following: 
• Date of receipt 
• Identification of each investigational device/piece of equipment (batch number or unique 
code) 
• Expiration date, as applicable 
• Date of use 
• Subject identification 
• Date on which the investigational device/piece of equipment was returned, if applicable 
• Date of return of unused 
Study spreadsheets documenting site inventory and device dispensation will be maintained 
and updated with each new participant/procedure. These files will be kept on a server that 
is back up daily. 
Stores the investigational device according to the manufacturer's recommendations with respect to 
temperature, humidity, lighting, and other environmental considerations: 
The devices will be kept in the EP lab under environmental conditions that are prescribed by 
the sponsor. 
Ensures that the device is stored in a secure area with limited access in accordance with applicable 
regulatory requirements: 

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The Bridge Balloon will be stored in the Operative Room at YNHH. It will be stored in a locked 
cabinet. Access to this cabinet will only be available to PI and the investigators. 
Distributes the investigational device to subjects enrolled in the IRB-approved protocol: 
The devices will be distributed to the PI prior to the extraction procedure. The enrollment 
status will also be confirmed as the participants enrollment will be highlighted on EPIC. 
 
 
 
1. Targeted Enrollment: Give the number of subjects: 
a. 
targeted for enrollment at Yale for this protocol_5   
b. If this is a multi-site study, give the total number of subjects targeted across all 
sites_25_ (8 sites including Yale) 
 
2. Indicate recruitment methods below.  Attach copies of any recruitment materials that will be used. 
 
Flyers 
Internet/Web Postings 
Radio 
Posters 
Mass E-mail Solicitation 
Telephone 
Letter 
Departmental/Center Website 
Television 
Medical Record Review 
Departmental/Center Research Boards 
Newspaper 
Departmental/Center Newsletters 
Web-Based Clinical Trial Registries 
YCCI Recruitment database 
Clinicaltrials.gov Registry (do not send materials to HIC) 
Other (describe): Patients who are already scheduled for elective lead extraction. 
 
3. Recruitment Procedures: 
a. Describe how potential subjects will be identified. 
 
The patients will be identified through the clinic evaluation and the EP schedule. 
Patients who are eligible or scheduled for Lead Extraction will be approached to participate 
in the study. The investigators will review the patients’ charts and they will determine eligible 
patients based on inclusion and exclusion criteria. 
 
b. Describe how potential subjects are contacted. 
 
The patients will be approached by the study team in the clinic or before the procedure to 
explain the study and to answer any questions. 
 
c. Who is recruiting potential subjects? 
All the investigators will be involved in recruiting potential subjects 
 
 
4. Screening Procedures 
a. Will email or telephone correspondence be used to screen potential subjects for 
eligibility prior to the potential subject coming to the research office? 
Yes 
No 
b. If yes, identify below all health information to be collected as part of screening and 
check off any of the following HIPAA identifiers to be collected and retained by the 
research team during this screening process. 
SECTION VII: RECRUITMENT/CONSENT AND ASSENT PROCEDURES 

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HEALTH INFORMATION TO BE COLLECTED: 
 
HIPAA identifiers: 
Names 
All geographic subdivisions smaller than a State, including: street address, city, county, precinct, zip codes and their 
equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly-available data from 
the Bureau of the Census: (1) the geographic unit formed by combining all zip codes with the same three initial digits contains 
more than 20,000 people, and (2) the initial three digits of a zip code for all such geographic units containing 20,000 or fewer 
people is changed to 000. 
Telephone numbers 
Fax numbers 
E-mail addresses 
Social Security numbers 
Medical record numbers 
Health plan beneficiary numbers 
Account numbers 
All elements of dates (except year) for dates related to an individual, including: birth date, admission date, discharge 
date, date of death, all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages 
and elements may be aggregated into a single category of age 90 or older 
Certificate/license numbers 
Vehicle identifiers and serial numbers, including license plate numbers 
Device identifiers and serial numbers 
Web Universal Resource Locators (URLs) 
Internet Protocol (IP) address numbers 
Biometric identifiers, including finger and voice prints 
Full face photographic images and any comparable images 
Any other unique identifying numbers, characteristics, or codes 
 
 
 
 
 
5. Assessment of Current Health Provider Relationship for HIPAA Consideration: 
Does the Investigator or any member of the research team have a direct existing clinical 
relationship with any potential subject? 
Yes, all subjects 
Yes, some of the subjects 
No 
 
If yes, describe the nature of this relationship. 
All  the  patients  at  YNHH  will  be  under  the  care  of  Dr.  Clancy  in  the  clinic  or 
electrophysiology service. 
 
 
 
6. Request for waiver of HIPAA authorization: (When requesting a waiver of HIPAA Authorization 
for either the entire study, or for recruitment purposes only. Note: if you are collecting PHI as part of 
a phone or email screen, you must request a HIPAA waiver for recruitment purposes.) 
 
Choose one: 

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□ For entire study 
☒ For recruitment purposes only 
□ For inclusion of non-English speaking subject if short form is being used 
 
i. Describe why it would be impracticable to obtain the subject’s authorization for 
use/disclosure of this data; 
Review of records is required to determine who would be eligible for the study. 
 
ii. If requesting a waiver of signed authorization, describe why it would be 
impracticable to obtain the subject’s signed authorization for use/disclosure of this 
data; N/A 
 
By signing this protocol application, the investigator assures that the protected 
health information for which a Waiver of Authorization has been requested will not 
be reused or disclosed to any person or entity other than those listed in this 
application, except as required by law, for authorized oversight of this research 
study, or as specifically approved for use in another study by an IRB. 
 
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of the Yale 
HIPAA-Covered entity must be accounted for in the “accounting for disclosures log”, by subject 
name, purpose, date, recipients, and a description of information provided.  Logs are to be 
forwarded to the Deputy HIPAA Privacy Officer. 
 
7. Required HIPAA Authorization: If the research involves the creation, use or disclosure of 
protected health information (PHI), separate subject authorization is required under the 
HIPAA Privacy Rule. Indicate which of the following forms are being provided: 
Compound Consent and Authorization form 
HIPAA Research Authorization Form 
 
8. Consent Personnel: List the names of all members of the research team who will be obtaining 
consent/assent. 
 
Jude Clancy, MD, Ryan Donovan, PA-C, Medhat Abdelmessih, MD 
 
9. Process of Consent/Assent: Describe the setting and conditions under which consent/assent will 
be obtained, including parental permission or surrogate permission and the steps taken to ensure 
subjects’ independent decision-making. 
 
The patient will be approached by the study team to explain the study, and to answer any 
questions. If the patient is in agreement, will sign the consent form and then will be enrolled 
in the study. 

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10. Evaluation of Subject(s) Capacity to Provide Informed Consent/Assent: Indicate how the 
personnel obtaining consent will assess the potential subject’s ability and capacity to consent to the 
research being proposed. 
 
The investigator will evaluate the subject’s capacity to consent base on the communication 
with the subject, his/her age (adult), no history of significant psychiatric illnesses. 
 
 
11. Documentation of Consent/Assent: Specify the documents that will be used during the 
consent/assent process. Copies of all documents should be appended to the protocol, in the same 
format that they will be given to subjects. 
 
The patient will sign a consent form, will be given a copy of the signed consent form. 
A consent process note will be signed by the consenting personnel and the PI. 
12. Non-English Speaking Subjects: Explain provisions in place to ensure comprehension for 
research involving non-English speaking subjects. If enrollment of these subjects is anticipated, 
translated copies of all consent materials must be submitted for approval prior to use. 
 
 
 
 
12(a) As a limited alternative to the above requirement, will you use the short form* for 
consenting process if you unexpectedly encounter a non-English speaking individual interested 
in study participation and the translation of the long form is not possible prior to intended 
enrollment? 
YES ☐ NO ☒ 
 
Non- English speaking individual will not be considered for the study. 
 
Note* If more than 2 study participants are enrolled using a short form translated into the same 
language, then the full consent form should be translated into that language for use the next time 
a subject speaking that language is to be enrolled. 
 
Several translated short form templates are found on our website 
at: http://www.yale.edu/hrpp/forms-templates/biomedical.html. If the translation of the short 
form is not available on our website, then the translated short form needs to be submitted to the 
IRB office for approval via amendment prior to enrolling the subject. Please review the 
guidance and presentation on use of the short form available on the HRPP website. 
 
If using a short form without a translated HIPAA Research Authorization Form, please 
request a HIPAA waiver in the section above. 
 
 
13. Consent Waiver: In certain circumstances, the HIC may grant a waiver of signed consent, or 
a full waiver of consent, depending on the study. If you will request either a waiver of consent, 
or a waiver of signed consent for this study, complete the appropriate section below. 

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Not Requesting a consent waiver 
Requesting a waiver of signed consent 
Requesting a full waiver of consent 
 
 
A. Waiver of signed consent: (Verbal consent from subjects will be obtained. If PHI is 
collected, information in this section must match Section VII, Question 6) 
Requesting a waiver of signed consent for Recruitment/Screening only 
If requesting a waiver of signed consent, please address the following: 
a. Would the signed consent form be the only record linking the subject and the research? 
Yes 
No 
b. Does a breach of confidentiality constitute the principal risk to subjects? 
Yes 
No 
 
OR 
 
c. Does the research activity pose greater than minimal risk? 
Yes If you answered yes, stop. A waiver cannot be granted. Please note: 
Recruitment/screening is generally a minimal risk research activity 
No 
AND 
d. Does the research include any activities that would require signed consent in a non- 
research context? 
Yes 
No 
 
Requesting a waiver of signed consent for the Entire Study (Note that an information 
sheet may be required.) 
If requesting a waiver of signed consent, please address the following: 
a. Would the signed consent form be the only record linking the subject and the research? 
Yes 
No 
b. Does a breach of confidentiality constitute the principal risk to subjects? 
Yes 
No 
 
OR 
 
c. Does the research pose greater than minimal risk? 
Yes If you answered yes, stop. A 
waiver cannot be granted. 
No 
AND 
d. Does the research include any activities that would require signed consent in a non- 
research context? 
Yes 
No 
 
B. Full waiver of consent: (No consent from subjects will be obtained for the activity.) 
Requesting a waiver of consent for Recruitment/Screening only 
a. Does the research activity pose greater than minimal risk to subjects? 
Yes If you answered yes, stop. A waiver cannot be granted. Please note: 
Recruitment/screening is generally a minimal risk research activity 
No 

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b. Will the waiver adversely affect subjects’ rights and welfare? 
Yes 
No 
c. Why would the research be impracticable to conduct without the waiver? 
Review of records is required to determine who would be eligible for the study. 
d. Where appropriate, how will pertinent information be returned to, or shared with 
subjects at a later date? 
The results from the study sites will be generated as a single manuscript to be 
published in the Heart Rhythm Journal. 
 
Requesting a full waiver of consent for the Entire Study (Note: If PHI is 
collected, information here must match Section VII, question 6.) 
 
If requesting a full waiver of consent, please address the following: 
 
a. Does the research pose greater than minimal risk to subjects? 
Yes If you answered yes, stop. A waiver cannot be granted. 
No 
b. Will the waiver adversely affect subjects’ rights and welfare? 
Yes 
No 
c. Why would the research be impracticable to conduct without the waiver? 
d. Where appropriate, how will pertinent information be returned to, or shared with 
subjects at a later date? 
 
 
 
 
 
 
Confidentiality & Security of Data: 
a. 
What protected health information (medical information along with the HIPAA identifiers) 
about subjects will be collected and used for the research? 
 
For each patient, the investigators will obtain the following baseline information: 
demographics information (age, sex, MRN, address, emergent contact, referring 
physician), medical history, Extraction procedure’s information and post-operative 
follow up information to determine the occurrence of any adverse events. 
 
b. How will the research data be collected, recorded and stored? 
 
All data will be collected and stored using encrypted digital forms 
 
c. How will the digital data be stored? 
CD 
DVD 
Flash Drive 
Portable Hard 
Drive 
Secured Server 
Laptop Computer 
Desktop Computer 
 Other 
d. What methods and procedures will be used to safeguard the confidentiality and security of 
the identifiable study data and the storage media indicated above during and after the subject’s 
participation in the study? 
SECTION VIII: PROTECTION OF RESEARCH SUBJECTS 

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1. Data on the excel spreadsheet will be stored in a in an encrypted format, 
password protected, on an encrypted Yale University computer/laptop connected 
to a secure server. 
 
2. If there be any reason to transfer data from one location to another, an encrypted 
data stick (iron key) issued by the Yale IT department, will be used. This will 
ensure data in encrypted format and not readable to others in the event it does 
fall into the wrong hands. 
 
3. The research data will be coded; all data used in the analysis and reporting of 
this study will be without identifiable reference to specific subject name. 
 
Do all portable devices contain encryption software? 
Yes 
No 
If no, see http://hipaa.yale.edu/guidance/policy.html 
e. What will be done with the data when the research is completed? Are there plans to destroy 
the identifiable data? If yes, describe how, by whom and when identifiers will be destroyed. If 
no, describe how the data and/or identifiers will be secured. 
The data will be secured in the department data base using secured encrypted computers 
on secured servers. 
 
f. Who will have access to the protected health information (such as the research sponsor, the 
investigator, the research staff, all research monitors, FDA, Yale Cancer Center Data and Safety 
Monitoring Committee (DSMC), SSC, etc.)? (please distinguish between PHI and de-identified 
data) 
Only the investigators and research staff. 
 
g. If appropriate, has a Certificate of Confidentiality been obtained? N/A 
 
h. Are any of the study procedures likely to yield information subject to mandatory reporting 
requirements? (e.g. HIV testing – reporting of communicable diseases; parent interview -incidents 
of child abuse, elderly abuse, etc.). Please verify to whom such instances will need to be reported. 
 
NO 
 
 
 
Potential Benefits: Identify any benefits that may be reasonably expected to result from the 
research, either to the subject(s) or to society at large. (Payment of subjects is not considered a 
benefit in this context of the risk benefit assessment.) 
 
There is no direct benefit for the subjects in this study. Also in the unlikely event the patient 
has an SVC tear the balloon is FDA approved and would be used in the emergent management of 
SVC tear. 
The study will focus on the effect of the Bridge balloon on the patient preparation clinical 
workflow, ease of insertion/positioning/deployment, and the ability to recognize proper 
inflation and vein sealing under fluoroscopy. 
SECTION IX: POTENTIAL BENEFITS 

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Understanding these factors will help build a more robust clinical workflow with the goal 
of better patient outcomes in the case of an SVC injury. The images and data generated 
during this study can help in dissemination of the practical use knowledge to fellow lead 
extractors. 
 
 
 
 
 
 
 
 
 
1. 
Alternatives: What other alternatives are available to the study subjects outside of the research? 
 
Outside of this research, there is no utility of the balloon unless there is an SVC tear as a 
complication of the lead extraction procedure. 
 
2. 
Payments for Participation (Economic Considerations): Describe any payments that will be 
made to subjects, the amount and schedule of payments, and the conditions for receiving this 
compensation. 
 
No compensation will be provided. 
 
3. 
Costs for Participation (Economic Considerations): Clearly describe the subject’s costs 
associated with participation in the research, and the interventions or procedures of the study that 
will be provided at no cost to subjects. 
 
All the procedures are standard of care and routinely used during the lead extraction 
procedures except the use of balloon which is the research part of this study. The device 
itself will be provided at no cost. 
 
4. 
In Case of Injury: This section is required for any research involving more than minimal risk. 
a. 
Will medical treatment be available if research-related injury occurs?   YES 
b. 
Where and from whom may treatment be obtained? 
Treatment will be obtained from the study doctor, Dr. Jude Clancy at Yale-New Haven 
Hospital 
c. 
Are there any limits to the treatment being provided? NO 
d. 
Who will pay for this treatment? 
 
If patients are injured while on study, they should seek treatment and contact the study doctor as 
soon as possible. Yale School of Medicine and Yale-New Haven Hospital do not provide funds 
for the treatment of research-related injury. If patient is injured as a result of their participation in 
this study, treatment will be provided. The patient or their insurance carrier will be expected to 
pay the costs of this treatment. No additional financial compensation for injury or lost wages is 
available. Patients do not give up any of your legal rights by signing this form. 
SECTION X: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS 

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e. 
How will the medical treatment be accessed by subjects? 
In the event of research related injury; subjects should contact Dr. Jude Clancy or any 
member of the research team.