VAscular Closure for Cardiac Ablation Registry (VACCAR)
Conditions: Atrial Fibrillation
Sponsor: Saint Luke's Health System

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SAINT LUKE’S HOSPITAL 
RESEARCH PROTOCOL INVOLVING HUMAN SUBJECTS  
 
Version date: 03/07/2018 
Principal Investigator: Sanjaya Gupta, MD 
Study Title: VAscular Closure for Cardiac Ablation Registry (VACCAR) 
Co- Investigator(s): Rakesh Ponnapureddy, MD 
 
 
I. Purpose, Background and Rationale 
A. Aim and Hypotheses  
Vascular Closure Devices (VCD) have been used to achieve hemostasis of arterial access 
sites following cardiac catheterization procedures. There is extensive literature available 
supporting the use of these devices for arterial access site closure, showing reduced time to 
hemostasis, earlier ambulation and reduced length of hospital stay in comparison to manual 
compression which is the traditional approach to achieve access site hemostasis. In 
contrast, there is not significant evidence supporting the use of these devices for closure of 
femoral venous access site, partly due to limited use of VCD in cardiac electrophysiology 
procedures, such as catheter ablation for atrial fibrillation and atrial flutter.  Another 
alternative to manual compression, the Figure of 8 stitch has also been used to achieve 
vascular closure follow catheter ablation of atrial fibrillation and atrial flutter, however it 
has not been studied formally.   
The aim of this registry is to better understand the ‘real-world’ utilization of VCD or Figure 
of 8 stitch(F08S) in cardiac ablation procedures and to understand any potential difference 
between VCD or F08S and manual compression. The outcomes of interest are vascular 
access site complication rate, time to ambulation and patient perception of pain and overall 
satisfaction, which is assessed via a survey. The hypothesis of this registry is that there will 
be an increased patient satisfaction and decreased rate of vascular and bleeding 
complications with use of either Perclose Proglide system or Figure of 8 stitch for venous 
closure post atrial fibrillation ablation and atrial flutter ablation procedures in comparison 
to standard manual compression. 
 
B. Background and Significance 
Vascular access site complications are an important cause of morbidity following cardiac 
catheterization procedures. These include recurrent access site bleeding, hematoma 

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formation, pseudoaneurysm, arterio-venous fistula, acute vascular thrombosis and distal 
embolization. Manual compression (MC) for 15- 30 minutes has been the ‘gold standard’ in 
achieving hemostasis of the access site after these procedures. However, this approach is 
limited by the need for transient interruption of heparin anticoagulation to perform sheath 
removal, prolonged bed rest of several hours post sheath removal, patient discomfort, and 
increased time demand for health care providers to perform manual closure. Vascular 
Closure Devices (VCD) were introduced into clinical practice in the mid-1990s with the aim 
of reducing access site bleeding associated with percutaneous coronary intervention 
procedures. [1]  
 
Several trials, involving patients who had arterial access, have demonstrated increased 
efficacy of VCD in comparison to MC as evidenced by a reduced time to hemostasis, earlier 
ambulation and reduced length of hospital stay. However, there are two studies that 
demonstrated an increased risk of vascular complications associated with use of these 
vascular closure devices, in particular groin hematoma and arterial pseudoaneurysm.[2,3] A 
larger meta-analysis that included 30 studies involving 37,066 patients concluded that the 
risk of complications was dependent upon the specific vascular closure device used and 
whether the procedure was a diagnostic catheterization or a percutaneous coronary 
intervention. In the overall analysis, these studies demonstrate a 2.25 fold increase in risk of 
complications with a VCD.[4]  
 
Despite this finding, the size of each of these individual trials included in the meta-analysis 
was modest (100-500 patients) and these studies were not powered for safety end points 
such as access site bleeding and pseudoanerysm. Hence, it is difficult to draw conclusions 
about safety end points from this meta-analysis. To address this issue, recently, a large 
multicenter randomized controlled trial (RCT) compared VCD to MC and concluded that VCD 
was non-inferior in terms of vascular access site complications and was associated with 
reduced time to hemostasis.[5,6]  
 
There have been only a few studies assessing patient comfort and satisfaction with VCD.  A 
RCT showed VCD to be associated with greater patient satisfaction compared to 
compression. It also allowed for earlier hemostasis and ambulation compared with both 
compression and VCD. [9] A study comparing one brand of VCD with compression showed 
significantly increased patient comfort, assessed by visual analogue scales, with VCD use. 
[10] A prospective study involving 1500 patients undergoing PCI procedures, followed by 
access site closure with MC, or two brands of VCD showed that patients treated with 1 
brand (Angio- Seal) reported greater overall satisfaction, better wound healing and lower 
discomfort in comparison to the other brand of VCD (Perclose Proglide) and MC.[11]  
Overall, the increase in patient satisfaction and decreased time to hemostasis with VCD use, 

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with no significant increase in complications provided a sound rationale for use of VCD over 
MC in daily clinical practice for arterial closure. 
 
In contrast to the arterial access studies summarized above, only a few small scale studies 
assessing the use of VCD for femoral venous access closure site have been published. A 
retrospective analysis of 26 patients undergoing deployment of VCD following cardiac 
electrophysiology procedures, published in 2015, showed successful deployment of 75 out 
of 76 vascular closure devices and they were no complications reported. [7] Another study 
involving 761 VCD deployments in the femoral vein following catheter ablation for atrial 
fibrillation procedure showed no significant reduction in vascular or non-vascular bleeding 
rate in comparison to MC. [8] 
 
Catheter ablation for treatment of atrial fibrillation/atrial flutter is a commonly performed 
procedure involving placement of 3 or 4 large (8-14 French) sheaths in the femoral vein. The 
procedure is performed on uninterrupted anticoagulation, which indicates that for warfarin 
and rivaroxaban the procedure is performed without holding any doses of anticoagulant 
medication.  For apixaban, dabigatran and edoxaban, the procedure is performed with 
holding the dose of anticoagulant the night before the procedure and the morning of the 
procedure.  The current standard of care is that at the conclusion of atrial fibrillation or 
atrial flutter ablation procedure, all venous sheaths are kept in place and the patient is 
transported to a recovery unit. Upon arrival in the recovery unit, the nursing staff will assess 
the ACT. Sheaths are not removed via manual compression until the ACT is < 165 seconds. 
During this time period, which may take several hours, the patients are lying flat on their 
back with their legs straight.  Once the ACT is <165 seconds, the nurses will apply manual 
compression for 15 to 20 minutes. Following hemostasis, the patients lie flat with their legs 
straight for 3-4 hours.  At that point, the access sites are rechecked to ensure hemostasis, 
and then the patient is allowed to ambulate. 
 
In contrast, the patient receiving a vascular closure device (VCD) undergoes sheath removal 
at the conclusion of the procedure and hemostasis is achieved before the patient is 
removed from the table. When the patient is transported to recovery, they must lie flat on 
their back for 1 hour and then they are permitted to ambulate, irrespective of their ACT.  
Both patients receiving MC and VCD are monitored overnight for any post op complications 
such as recurrent bleeding, hematoma, pain or swelling from vascular access site.  
 
Similarly, the Figure of 8 stitch has been used to achieve vascular closure following 
procedures involved access to the femoral vein, including leadless pacemaker implantation 
as well as catheter ablation of atrial fibrillation and atrial flutter.  The process involves 
placing 0 silk suture through the skin and subcutaneous tissue below the lowest venous 

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access site and then through the skin and subcutaneous tissue above the highest venous 
access site in a Figure of 8 pattern.  The Figure of 8 stitch requires administration of 
protamine a few minutes prior to sheath removal, removing the sheaths and the tying the 0 
silk suture which pulls together the skin and tissue above and below the access site and 
then holding pressure at the groin for 5 minutes after application of the F08S.  The following 
day, the F08S has to be cut prior to discharge. In a study of 200 patients undergoing 
cryoablation, patients were allocated to receive manual compression or F08S.  There was no 
significant difference in incidence of hematoma or re-bleeding at the access site between 
the two groups [12] .    
 
It is not known if routine use of VCD or F08S would lead to increased patient satisfaction, 
earlier ambulation, earlier discharge and decreased rate of complications. 
 
This registry is Investigator initiated. 
 
 
C. Rationale 
The rationale of this registry is to better understand the ‘real-world’ utilization of VCD and 
F08S in cardiac ablation procedures and to understand any potential difference between 
VCD/ F08S and manual compression.  The outcomes of interest are vascular access site 
complication rate, time to ambulation and patient perception of pain and overall 
satisfaction, which is assessed via a survey. 
The aim of this registry to assess difference in patient satisfaction and rate of vascular and 
bleeding complications with use of either Perclose Proglide system or F08S for venous 
closure post atrial fibrillation ablation and atrial flutter ablation procedures in comparison 
to standard manual compression. If they are found to increase patient satisfaction as 
hypothesized, cardiac electrophysiologists can use VCD or F08S for access site closure 
instead of manual compression. 
 
II. Research Plan and Design 
 
A. Study Objectives: The objective of this registry is to find out if there is a difference 
in patient satisfaction and rate of vascular and bleeding complications with use of 
Perclose Proglide system or F08S for venous closure post atrial fibrillation and atrial 
flutter procedures in comparison to manual compression.  
 
B. Study Type and Design: The design will be a prospective observational registry 
collecting data on patients who underwent catheter ablation for atrial fibrillation and 
atrial flutter, including administration of a patient survey. 

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C. Sample size, statistical methods, and power calculation 
      As a registry, there is no targeted enrollment, however it is expected that approximately             
120 patients would be enrolled in 6 months.  
         
D. Subject Criteria (See Vulnerable Populations appendix, if applicable): 
1. Inclusion criteria:  
• Patients undergoing a catheter ablation procedure (radiofrequency ablation  
                or cryoablation) to treat symptomatic paroxysmal atrial fibrillation or atrial flutter. 
 
• Patients willing to participate in a short written survey. 
2. Exclusion criteria: 
•  Patients undergoing ablation for an arrhythmia other than atrial fibrillation/atrial 
flutter or who are not candidates for an ablation procedure for treatment of atrial 
fibrillation/atrial flutter. 
• Patients who are not able to read or understand the English language. 
 
• Patients who had recent access site complications within the same hospitalization.  
 
• Patients who have baseline thrombocytopenia (platelet count less than 80) or 
known coagulopathy (INR > 1.5). 
 
3. Withdrawal/Termination criteria:  
 
No necessary safety precautions are to be applied to those who withdraw. 
A study subject may participate in any another research study while participating in this 
registry.  
 
E. Specific methods and techniques used throughout the study  
 

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 Once approval from the Institutional Review Board is obtained, patients who underwent 
catheter ablation for atrial fibrillation or atrial flutter will be approached for inclusion in this 
registry. The morning after the procedure, patients will be requested to fill out informed 
consent documents, followed by a survey (Appendix A).  This survey will include parameters 
such as their perception of pain following the procedure, discomfort experienced, any 
complications that may have occurred after the procedure, their preference if a repeat 
procedure was to be performed, as well the patient’s overall satisfaction with the recovery 
process. A retrospective chart review of these patients would be done to assess for any 
complications in the post procedure period, such as bleeding, hematoma formation, 
pseudo-aneurysm, arterio-venous fistula etc. Other parameters to be measured include the 
time to achieve hemostasis, time to ambulate and length of hospital stay.  These 
parameters are all recorded in the patient’s clinical record as part of the standard of care.   
 
 
F. Risk/benefit assessment:  
 Patients in this registry will not be exposed to any additional procedural risks as all      
treatments are in accordance with accepted clinical practice.  The only potential risk would 
be a breach of Protected Health Information (PHI) confidentiality. 
The potential benefit of participating in the study would be for the future  
patients undergoing catheter ablation procedures for atrial fibrillation and atrial  
flutter.                 
 
G. Location where study will be performed:  
The morning after the procedure, patients in the cardiovascular recovery unit will be 
requested to fill out informed consent documents, followed by a survey (Appendix A). Each 
survey will be assigned a randomly generated confidential ID number and the data from the 
survey will be entered and analyzed into a spreadsheet that does not contain any patient 
identification information. A separate password protected spreadsheet will be maintained 
with an index of the randomly generated confidential ID numbers and the corresponding 
patient name and date of birth, however this will be stored separately and only the principal 
investigator will have access to this file.     
 
H. Collaboration (with another institution, if applicable): N/A 

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I. Single IRB Review for a Multi-site study (if applicable): N/A 
 
J. Community-Based Participatory Research (if applicable): N/A 
 
K. Personnel who will conduct the study, including: 
1. Indicate, by title, who will be present during study procedure(s): Sanjaya Gupta, 
MD 
2. Primary responsibility for the following activities, for example:  
3. Determining eligibility: Sanjaya Gupta, MD 
4. Obtaining informed consent: Rakesh Ponnapureddy, MD 
5. Providing on-going information to the study sponsor and the IRB:  EP Research 
Coordinator and Regulatory Specialist 
6. Maintaining participant's research records:  EP Research Coordinator 
7. Completing physical examination: Sanjaya Gupta, MD 
8. Taking vital signs, height, weight: Rakesh Ponnapureddy, MD 
9. Drawing / collecting laboratory specimens: N/A 
10. Performing / conducting tests, procedures, interventions, questionnaires: 
Rakesh Ponnapureddy, MD  
11. Completing study data forms: Rakesh Ponnapureddy, MD 
12. Managing study database: Rakesh Ponnapureddy, MD 
 
L. Assessment of Subject Safety and Development of a Data and Safety 
Monitoring Plan 
 
 
 
III. Subject Participation 
 

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A. Recruitment: The morning after the procedure, Dr. Ponnapureddy will approach 
patients who underwent an ablation on the previous day and provide detailed 
information about the registry to the patients. 
B. Screening Procedures or Interview/questionnaire: N/A 
C. Informed consent process and timing of obtaining of consent 
If the patient is agreeable to participate, Dr. Ponnapureddy will request they fill out 
informed consent documents, followed by a survey (Appendix A).   Patients will not be 
coerced into participation and it will be emphasized to the patient that participation is 
voluntary.  If patients are unable to provide informed consent due to cognitive or 
psychiatric impairment, they will not be enrolled in the registry.   
D. Alternatives to Participation: If patients decline participation, they will continue 
to receive post-procedure care in the usual manner.   
E. Costs to Subjects:  There are no costs to the subject that could be incurred as part 
of this research study 
F. How new information will be conveyed to the study subject and how it 
will be documented: If new information becomes available that may potentially 
impact the study subject, they will be notified by the principal investigator, Dr. 
Sanjaya Gupta.   
G. Payment, including a prorated plan for payment: Patients will not receive any 
payment for the study.  
H. Payment for a research-related injury: There is no possibility of injury in this 
study. 
IV. Data Collection and Protection 
A. Data Management and Security: The morning after the procedure, patients will 
be requested to fill out informed consent documents, followed by a survey (Appendix 
A).  This survey will include parameters such as their perception of pain following the 
procedure, discomfort experienced, any complications that may have occurred after 
the procedure, their preference if a repeat procedure was to be performed, as well 

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the patient’s overall satisfaction with the recovery process.  Each survey will be 
assigned a randomly generated confidential ID number and the data from the survey 
will be entered an analyzed into a spreadsheet that does not contain any patient 
identification information.  A separate password protected spreadsheet will be 
maintained with an index of the randomly generated confidential ID numbers and the 
corresponding patient name and date of birth, however this will be stored separately 
and only the principal investigator will have access to this file. Once the survey data 
has been entered and confirmed, the original survey will be destroyed.  A 
retrospective chart review of these patients would also be done to assess for any 
complications in the post procedure period, such as bleeding, hematoma formation, 
pseudo-aneurysm, arterio-venous fistula etc. Other parameters to be measured 
include the time to achieve hemostasis, time to ambulate and length of hospital stay.  
These parameters are all recorded in the patient’s clinical record as part of the 
standard of care. All documentation related to the procedure will keep in a locked, 
secure file cabinet at St. Luke’s Hospital and/or an encrypted, protected electronic 
storage device that can only be accessed by participating investigators. 
 
B. Sample / Specimen Collection: N/A 
C. Tissue Banking Considerations: N/A 
D. Procedures to protect subject confidentiality: All documentation related to the 
procedure will be kept in a locked, secure file cabinet at St. Luke’s Hospital and/or 
encrypted, protected electronic storage device that can only be accessed by 
participating investigators.  
E. Quality Assurance / Monitoring 
1. 
At the time of data collection, Drs. Gupta and Ponnapureddy will review the 
data together to ensure that it is entered correctly from the survey into the 
spreadsheet.  Any discrepancy will be analyzed before the original paper 
form is discarded.   
 
V.Data Analysis and Reporting 
A. Statistical and Data Analysis:  Categorical variables will be compared with Chi-
Square analysis.  The patient factors that may contribute to the outcomes listed 

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below will be analyzed via logistic regression with subsequent multivariate logistic 
regression designed to compare these risk factors.   
B. Outcome: The main outcomes of interest are  
                 Perception of pain during recovery process 
                 Overall satisfaction with recovery process 
                 Time to achieve hemostasis 
                 Time to ambulate following hemostasis 
                 Bleeding and vascular complications 
                 Need for additional manual compression following initial hemostasis 
                 Use of protamine sulfate to reverse anticoagulation 
                 Length of hospital stay 
                
                 We expect patients who received the vascular closure device to have a reduced 
perception of pain, increased overall satisfaction, reduced time to achieve hemostasis, 
reduced time to ambulate following hemostasis, reduced bleeding and vascular 
complications, reduced need for additional manual compression following initial hemostasis 
and reduced length of hospital stay. 
              
I. Study results to participants: If new information becomes available that may 
potentially impact the study subject, they will be notified by the principal 
investigator, Dr. Sanjaya Gupta.    
J. Publication Plan: The intent is to publish this study in a peer-reviewed 
cardiology journal 
 
VI. Bibliography / References / Literature Cited 
 
1]  Dauerman HL, Applegate RJ, Cohen DJ. Vascular closure devices: the second decade. J 
Am Coll Cardiol. 2007;50(17):1617-1626. 
2]Koreny M, Riedmuller E, Nikfardjam M, Siostrzonek P, Mullner M. Arterial puncture 
closing devices compared with standard manual compression after cardiac catheterization: 
systematic review and meta analysis. JAMA. 2004. 291930:350-357. 

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3] Biancari F, D’Andrea V, Di Marco C, Savino G, Tiozzo V, Catania A. Meta-analysis of 
randomized trials on the efficacy of vascular closure dvices after diagnostic angiography and 
angioplasty . Am Heart J. 2010;159(4):518-531. 
4]Nikolsky E, Mehran R, Halkin A, et al. Vascular Complications Associated With 
Arteriotomy Closure Devices in Patients Undergoing Percutaneous Coronatry Procedures. A 
meta analysis. J Am Coll Cardiol 2004;44:1200. 
5] Stefanie Schulz-Schüpke, MD1,2; Sandra Helde, cand med1; Senta Gewalt, cand med1; et 
al. Comparison of Vascular Closure Devices vs Manual Compression After Femoral Artery 
Puncture. The ISAR-CLOSURE Randomised Clinical Trial. JAMA. 2014;312(19):1981-
1987. doi:10.1001/jama.2014.15305 
6] Vaitkus PT. A meta analysis of percutaneous vascular closure devices after diagnostic 
catheterization and percutaneous coronary intervention. J Invasive Cardiol 2004;16:243-246. 
7] Maraj I, Budzikowski AAS, Ali W, Mitre CA, Kassotis J. Use of vascular closure device 
is safe and effective in electrophysiological procedures. J Interv Card Electrophysiol. 2015. 
Aug;43(2):193-5. doi: 10.1007/s 10840-015-0005-5. Epub 2015 Apr 29. 
8]Abo-Salem E, Miller B, Wexler L, Attari M. Vascular Closure Devices for venous accesses 
in anticoagulated patients after catheter ablation for Atrial Fibrillation. JACC March 17,2015. 
Volume 65, Issue 10S. 
9] Martin J, Pratsos A, Magargee E, Mayhew K, Pensyl C, Nunn M, Day F, Shapiro T. A 
Randomised Trial Comparing Compression, Perclose Proglide and Angio- Seal VIP for 
Arterial Closure Following Percutaneou Coronary Intervention: The CAP trial. 
Catheterisation and Cardiovascular Interventions 71:1-5 (2008)  
doi 10.1002/ccd.21333 
10] Noguchi T, Miyazaki S, Yasuda S, Baba T, Sumida H, Morii I, Daikoku S, Goto Y, 
Nonogi H. A randomized Controlled Trial of Prostar Plus for Haemostasis in Patients After 
Coronary Angioplasty. Eur J Vasc Endovasc Surg 19,451-455(2000) 
doi:10.1053/ejvs.1999.1071. 
11] Duffin DC, Muhlestein JB, Allisson SB, et al. Femoral arterial puncture management 
after percutaneous coronary procedures: a comparison of clinical outcomes and patient 
satisfaction between manual compression and two different vascular closure devices. J 
Invasive Cardiol 2001;13:354-62. 
12] Aytemir K, Canpolat U, Yorgun H, Evranos B, Kaya EB, Sahinger ML, Ozer N. 
Usefulness of ‘figure-of-eight’ suture to achieve haemostasis after removal of a 15-French 
calibre femoral venous sheath in patients undergoing cryoablation.  Europace 18(10), 1545-
1550 (2016) 
 
 

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Post Ablation Procedure Patient Survey 
(please circle one answer per question) 
 
Confidential ID: __________ 
 
 
 
1. Please rate your pain during post-procedure recovery period, was your pain: 
 
 
 
 
 
2. Please rate your discomfort experienced while walking after your procedure.  Was it: 
 
 
 
 
 
 
 
 
 
3. Please rate your overall satisfaction with your post-procedure recovery.  Are you: 
 
 
 
  
 
 
4. Have you had an ablation procedure in the past, which was followed by manual  
compression at the groin site?  
 
    
Yes 
No 
 
 
A. If you answerd yes, and if you had a closure device used for this procedure, would you prefer 
this method over manual compression: 
 
Yes 
No 
 
 
 
5. Please rate your level of concern for having a bleeding event after the procedure, are you: 
 
       
 
Much worse than 
anticipated 
Worse than 
anticipated 
About what you 
anticipated 
Better than 
anticipated 
Much better than 
anticipated 
Much worse than 
anticipated 
Worse than 
anticipated 
About what you 
anticipated 
Better than 
anticipated 
Much better than 
anticipated 
 
 
 
 
 
Extremely 
dissatisfied 
Dissatisfied 
Neither satisfied or 
dissatisfied 
Satisfied 
Extremely satisfied 
Extremely 
concerned 
Very concerned 
Concerned 
 Slightly 
concerned 
Not concerned 

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6. Would you have been comfortable being discharged home, about 4 hours after you were allowed 
to sit up, on the same day as your ablation?   
 
Yes 
No 
  
 
7. Please write any additional comments regarding your post-procedure recovery below: 
 
        ____________________________________________________________________________ 
 
        ____________________________________________________________________________ 
 
       ____________________________________________________________________________ 
 
       ____________________________________________________________________________ 
 
       Thank you for your participation in this survey.