Hemodynamics Measurement in Radiofrequency Catheter Ablation
Phase: NA
Conditions: Cardiac Arrhythmia
Sponsor: Emory University

IRB Protocol Version 1- 12/5/2019 
Full study title:  Hemodynamics Measurement in Radiofrequency Catheter Ablation 
Protocol version date:  December 5, 2019 
NCT Number: NCT04227119 
Emory University Investigator 
Anand Shah, MD, Assistant Professor of Medicine, Department of Cardiology 
 
 
 

IRB Protocol Version 1- 12/5/2019 
Introduction/Background: Catheter ablation of cardiac arrhythmia is performed to offer 
symptomatic relief from a variety of atrial, ventricular and atrio-ventricular rhythms.  Irrigated 
ablation catheters are commonly used for ablation of arrhythmias arising from the left heart 
and coronary sinus, to mitigate potentials risks of catheter ablation, including char formation on 
the catheter tip2. These catheters contain internal channels allowing for infusion of an external 
fluid directly to the tip of the catheter, where the fluid is sprayed through numerous end holes 
allowing for cooling of the catheter ablation tip2,3.  Normal and half normal saline are the most 
commonly used irrigant fluids. 
Fluid filled catheters are also the primary tool utilized to assess intravascular and intracardiac 
pressures and hemodynamics in the cardiac catheterization suite and intensive care unit.  
Intravascular hemodynamics allow assessment and diagnosis of a variety of cardiac conditions 
which are commonly found in patient undergoing catheter ablation, including congestive heart 
failure, diastolic dysfunction, and valvular heart disease4.   However, the fluid filled catheters 
commonly used for these assessments are single lumen and generally have a minimal diameter 
of 5 French for intracardiac catheters.  Principles of fluid mechanics are characterized by 
Poiseuille’s law and Bernoulli’s law, which suggest that the radius of the fluid filled catheter will 
impact the reliability of the reading.  “Dampening” of pressure waveforms are observed in 
smaller diameter catheters and may lead to underestimation of peak pressure and 
overestimation of the nadir pressure gradient. 
It is unknown if transduction of pressures from the tip of an irrigated ablation catheter will yield 
equivalent results compared to use of a single 5F lumen catheter. 
The purpose of this study is to test the hypothesis that transduction of intracardiac pressures 
using an irrigated ablation catheter placed as standard of care for the ablation procedure is 
equivalent to transduction of pressures using a standard 5F balloon tipped PA catheter placed 
only for this research study. 
Objectives: 
The main objective of this study is to take intracardiac pressure measurements and pressure 
waveforms with both a “gold standard” balloon tipped pulmonary artery catheter placed for 
this study and an irrigated ablation catheter placed as standard of care for the procedure in 
order to evaluate the following 2 questions: 
1. Determine accuracy of intracardiac pressure measurements as assessed by the balloon 
tipped pulmonary artery catheter and by an irrigated ablation catheter. 
2. Determine accuracy of intracardiac pressure waveforms measured by the balloon tipped 
pulmonary artery catheter and by an irrigated ablation catheter. 

IRB Protocol Version 1- 12/5/2019 
Research Design: The study will occur in patients undergoing routine cardiac ablation of his/her 
arrhythmia with planned use of an irrigated ablation catheter.  The irrigation port of the 
irrigated ablation catheter will be connected via a three way stop cock to the irrigation tubing 
via 1 port and to a pressure transducer via the second port (see figure 1).  All ports will be 
flushed through to the tip of the catheter to ensure no air in the line, per standard protocol.  
The pressure transducer will be leveled and “zeroed” per routine using CARDIOLAB software.  A 
5F MPA catheter will be prepared in similar fashion to the ablation, without an irrigant line 
running.  “Zero” will be confirmed by positioning each catheter next to each other and 
assessing for equal waveform values. 
Ablation and catheter manipulation will be done per routine under the supervision of a 
qualified electrophysiologist.  The pressure line will be left “off” with the stopcock during the EP 
study and ablation, and whenever pressure assessment is not being performed. 
After completion of ablation/study, the ablation catheter will be serially positioned in the 
cardiac chambers (left OR right atrium, left OR right ventricle).  Because pressure values, slopes 
and characteristics are similar between the atria and ventricles, all 4 chambers will not be 
sampled.  The stop cock will be turned to the pressure transducer and waveforms will be stored 
corresponding to each chamber.  Next, the catheter will be removed and replaced with a 5F 
balloon tipped PA catheter which will be positioned under fluoroscopic guidance in each 
previously evaluated chamber.  The placement of the balloon tipped PA catheter and 
measurements for this study will take about 10 additional minutes.   
Figure 1: Stop cock connected to irrigant port of ablation catheter.  In current position, standard irrigant 
is flowing through catheter via manufacturer pump. 

IRB Protocol Version 1- 12/5/2019 
 
 
 
Figure 2: Stop cock is now turned to open the irrigant port to the pressure sensing line.  In this 
configuration, pressure is transduced from the tip of the catheter. 
 

IRB Protocol Version 1- 12/5/2019 
 
Risks/benefits: Risks of this procedure are related to insertion of the balloon tipped pulmonary 
catheter into the heart.  The catheter will be placed through access sites in the right and left 
femoral vein which are used for the ablation (no new vein access is required for this study) 
Insertion risks include <1% risk of stroke, infection, damage to heart or valves or damage to 
conduction centers of heart. 
Potential benefits to the subject include assessment and analysis of intracardiac pressures by 
the ‘gold-standard’ technique which can be useful in diagnosing conditions such as congestive 
heart failure, valve disease and diseases of the pericardium.  Some patients develop shortness 
of breath after ablation procedures, and this can be prevented with assessment of intracardiac 
pressures after ablation.  Although the purpose of this study is to assess the accuracy of these 
measurements from the ablation catheter, any unexpectedly abnormal patient findings such as 
elevated pressures or evidence of valve disease will be evaluated further per standard practice 
(echo, overnight observation, administering diuretic medications).   
Potential benefits not to the subject include improved safety and monitoring during ablation 
procedures for future patients undergoing ablation. 
Data to be collected: The patients’ demographics, ablation indication, and prior 
echocardiogram study (when available) will be retrieved from chart review. The systolic, 
diastolic, and mean pressure values and wavform tracings for each heart chamber assessed will 
be collected during the procedure.  
Data Storage: Data will be stored on Emory HIPAA compliant servers. All documents and 
information will be password protected with no information saved to personal computers.  
Patient selection: Study patients will be recruited among all patients older than 18 years old 
undergoing elective ablation for an arrhythmia at Emory University Hospital.  Up to 15 patients 
will be enrolled in order to obtain a minimum of 10 useable comparison datasets.  
Informed Consent: Following education on the study protocol, patients will be offered the 
option to enroll. Informed consent will be obtained by approved research personnel in a private 
area. If the patient agrees to participate, consent will be documented. Consent will occur the 
day of the scheduled ablation procedure.   
Compensation for time and effort: There is no compensation for participation in this study.  
This research will add about 10 minutes to the standard of care procedure.  . 

IRB Protocol Version 1- 12/5/2019 
Data analysis: The systolic, diastolic and mean pressure values for each chamber assessed will 
be compared between the RF ablation catheter derived measurement and the MPA catheter 
measurement.  Measurements will be made in duplicate for each value.  Comparison will be 
made using T – Test and a Kappa statistic.   
Waveforms will be compared using a MACLAB system, by determining a mean gradient 
between the two wavforms.  These values will be compared using a T –Test.  All analyses will be 
performed using Microsoft Excel and Graphpad Prism. 
Safety: Positioning of both catheters (ablation catheter and PA catheter ) will be done under 
continuous ultrasound guidance to ensure positioning of the catheter without secondary 
damage to the heart, heart valves or heart muscle.  Fluoroscopy and 3-dimensional computer 
mapping will be used or immediately available for use in assisting positioning when needed.  All 
catheter manipulation will be done by an experienced, Board certified cardiologist with greater 
than 10 years of experience in PA catheter manipulation and positioning (AS). 
The tip of the PA catheter has a balloon which will be inflated whenever advancing the balloon 
forward.  This reduces risk of perforation as the catheter will bounce off the walls of the heart 
when encountered. 
The catheter will be primarily position with use of guiding catheters which are already position 
in the chamber of interest(s) for the purpose of the catheter ablation procedure itself.  This will 
also help minimize risk and time associated with PA catheter manipulation. 
Equipment necessary to treat potential complications of catheter manipulation such as fluid or 
bleeding around the heart will be immediately available in the procedure suite.  Operators will 
be experienced and qualified to perform stabilizing and treating procedures in case of such 
emergency. 
Safety analysis: Safety assessments will consist of monitoring and recording all adverse events 
and serious adverse events. While they are not anticipated, adverse events will be summarized 
using the frequency of subjects for each level.  
Data and Safety Monitoring Plan: Oversight of the progress and safety of the trial will be 
provided by the PI. Adverse events are not anticipated, but any occurring will be reported to 
Emory IRB policies and procedures.   
Monitoring will be conducted on-site as self-monitoring using the Emory IRB (CTAC) self-
monitoring tool.  Self-monitoring will occur after the first subject is enrolled and will also occur 
after 5, 10, and 15 subjects (study completion) have been enrolled.  As stated the CTAC self-
monitoring tool will be followed, with special emphasis on examining procedural safety 

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associated with the PA catheter manipulation and ensuring compliance with the measurement 
technique as stated in the protocol.  Any reportable safety event or reportable protocol 
deviation will be promptly reported to the Emory IRB. 
Confidentiality: Patients will be assigned an identifier number. Data will be stored on a secure 
drive supported by Emory healthcare. Only pertinent members of Emory Healthcare/ SOM who 
have undergone HIPAA training will have access to the spreadsheet. PHI information including 
the informed consent forms will be stored in a locked space in the PI’s office.  
 
References: 
1. Page RL et. al. 2015 ACC/AHA/HRS guideline for the management of adult patients with 
supraventricular tachycardia: a report of the American College of Cardiology/American Heart 
Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll 
Cardiol 2016;67;e27–115. 
2. Thomas SP et. al. A comparison of open irrigated and non-irrigated tip catheter ablation for 
pulmonary vein isolation.  Europace. 2004 Jul;6(4):330-5. 
3. Chinitz LA et. al. Safety and efficiency of porous-tip contact-force catheter for drug-refractory 
symptomatic paroxysmal atrial fibrillation ablation: results from the SMART SF trial.  Europace. 
2018 Nov 1;20(FI_3):f392-f400. doi: 10.1093/europace/eux264. 
4. Nossaman BD, et. al. History of Right Heart Catheterization: 100 Years of Experimentation 
and Methodology Development Cardiol Rev. 2010 Mar–Apr; 18(2): 94–101.